Active Psoriatic Arthritis (PsA) | ORENCIA® (abatacept) (2022)

Important Safety Information
for ORENCIA® (abatacept)

Increased Risk of Infection with Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult moderate to severe rheumatoid arthritis (RA) patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in &lt0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Increased Risk of Adverse Reactions When Used in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should
be undertaken with caution, and such
patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in
patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. The range of time to onset of the event was 49 to 89 days post-transplant. Monitor patients for EBV reactivation in accordance with institutional practices. Before administering ORENCIA, provide recommended prophylaxis for EBV infection and continue for 6 months post-transplantation to prevent EBV-associated PTLD. Cytomegalovirus (CMV) invasive disease occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 7% (n=8) experienced CMV invasive diseases up to day 225 post-transplant. The median time to onset of the event was 91 days post-transplant. CMV invasive diseases predominantly involved the gastrointestinal tract. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation during treatment and for six months following HSCT.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

Most Serious Adverse Reactions: In controlled clinical trials, adult RA patients experienced serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In the GVHD-1 study, serious adverse reactions reported in >5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal
pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%).

Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in <10% of patients who received ORENCIA in combination with calcineurin inhibitor and methotrexate in Study GVHD-1 included EBV reactivation.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested. ORENCIA may only be administered as an intravenous (IV) infusion for the prophylaxis of aGVHD in patients undergoing HSCT. The safety and effectiveness of ORENCIA have not been established in pediatric patients younger than 2 years of age for prophylaxis of aGVHD.

Please click here for Full Prescribing Information Active Psoriatic Arthritis (PsA) | ORENCIA® (abatacept) (1)

Reference: ORENCIA [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.

(Video) ASTRAEA follow-up results support sustained benefits of abatacept in PsA | Oliver FitzGerald

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Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA® (abatacept) is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Adult Psoriatic Arthritis:
ORENCIA® (abatacept) is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Prophylaxis for Acute Graft versus Host Disease: ORENCIA® (abatacept) is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Important Safety Information for ORENCIA® (abatacept)

Increased Risk of Infection with Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult moderate to severe rheumatoid arthritis (RA) patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Increased Risk of Adverse Reactions When Used in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. The range of time to onset of the event was 49 to 89 days post-transplant. Monitor patients for EBV reactivation in accordance with institutional practices. Before administering ORENCIA, provide recommended prophylaxis for EBV infection and continue for 6 months post-transplantation to prevent EBV-associated PTLD. Cytomegalovirus (CMV) invasive disease occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 7% (n=8) experienced CMV invasive diseases up to day 225 post-transplant. The median time to onset of the event was 91 days post-transplant. CMV invasive diseases predominantly involved the gastrointestinal tract. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation during treatment and for six months following HSCT.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed
with abatacept.

Most Serious Adverse Reactions: In controlled clinical trials, adult RA patients experienced serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In the GVHD-1 study, serious adverse reactions reported in >5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%).

Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in <10% of patients who received ORENCIA in combination with calcineurin inhibitor and methotrexate in Study GVHD-1 included EBV reactivation.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested. ORENCIA may only be administered as an intravenous (IV) infusion for the prophylaxis of aGVHD in patients undergoing HSCT. The safety and effectiveness of ORENCIA have not been established in pediatric patients younger than 2 years of age for prophylaxis of aGVHD.

Please click here for Full Prescribing Information Active Psoriatic Arthritis (PsA) | ORENCIA® (abatacept) (5)

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Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA® (abatacept) is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Adult Psoriatic Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with active psoriatic
arthritis (PsA).

Prophylaxis for Acute Graft versus Host Disease: ORENCIA® (abatacept) is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients 2 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Important Safety Information for ORENCIA® (abatacept)

Increased Risk of Infection with Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult moderate to severe rheumatoid arthritis (RA) patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In postmarketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

Increased Risk of Adverse Reactions When Used in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo, including COPD exacerbations, cough, rhonchi, and dyspnea. In the study, 97% of COPD patients treated with ORENCIA developed adverse events versus 88% treated with placebo. Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) Reactivation in aGVHD Prophylaxis after Hematopoietic Stem Cell Transplant (HSCT): Post-Transplant Lymphoproliferative Disorder (PTLD) occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 4 patients (3.4%) experienced PTLD. All the PTLD events were associated with Epstein-Barr virus (EBV) infection. The range of time to onset of the event was 49 to 89 days post-transplant. Monitor patients for EBV reactivation in accordance with institutional practices. Before administering ORENCIA, provide recommended prophylaxis for EBV infection and continue for 6 months post-transplantation to prevent EBV-associated PTLD. Cytomegalovirus (CMV) invasive disease occurred in patients who received ORENCIA for aGVHD prophylaxis during unrelated HSCT. Of 116 patients who received ORENCIA, 7% (n=8) experienced CMV invasive diseases up to day 225 post-transplant. The median time to onset of the event was 91 days post-transplant. CMV invasive diseases predominantly involved the gastrointestinal tract. Monitor patients for CMV infection/reactivation for 6 months post-transplant regardless of the results of donor and recipient pre-transplant CMV serology. Consider prophylaxis for CMV infection/reactivation during treatment and for six months following HSCT.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed
with abatacept.

Most Serious Adverse Reactions: In controlled clinical trials, adult RA patients experienced serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo). In the GVHD-1 study, serious adverse reactions reported in >5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%).

Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in <10% of patients who received ORENCIA in combination with calcineurin inhibitor and methotrexate in Study GVHD-1 included EBV reactivation.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested. ORENCIA may only be administered as an intravenous (IV) infusion for the prophylaxis of aGVHD in patients undergoing HSCT. The safety and effectiveness of ORENCIA have not been established in pediatric patients younger than 2 years of age for prophylaxis of aGVHD.

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Please click here for Full Prescribing Information Active Psoriatic Arthritis (PsA) | ORENCIA® (abatacept) (6)

(Video) Management Strategies for Psoriatic Arthritis

FAQs

Can ORENCIA be used for psoriatic arthritis? ›

Orencia (also known by its generic name abatacept) was approved by the FDA in July 2017 for the treatment of adults with active psoriatic arthritis. It is also approved to treat rheumatoid arthritis and juvenile idiopathic arthritis.

How effective is ORENCIA for psoriatic arthritis? ›

Reduced symptoms

48% of people felt symptom relief taking ORENCIA with or without methotrexate compared with 19% of people taking placebo with or without methotrexate.

How long does it take for abatacept to work? ›

How long will it take to work? As with all of the biologics, you may not feel the effects of abatacept right away. Some people begin to feel the effects of the medication in six to eight weeks; however, it may take three to six months to feel its full effect.

What is the drug of choice for psoriatic arthritis? ›

The most commonly used DMARD is methotrexate (Trexall, Otrexup, others). Others include leflunomide (Arava) and sulfasalazine (Azulfidine). Side effects can include liver damage, bone marrow suppression, and lung inflammation and scarring (fibrosis).

What is the best biologic for psoriatic arthritis? ›

New psoriatic arthritis treatment guidelines from the American College of Rheumatology say that most people with active psoriatic arthritis (PsA) should choose an anti-TNF drug, such as adalimumab (Humira) or infliximab (Remicade), as their first line of therapy.

How long can you stay on ORENCIA? ›

Orencia treats long-lasting diseases. So you may need to take it long term. For graft-versus-host disease prevention, you'll only take Orencia for about 1 month. Talk with your doctor about how long you should use this drug.

Does ORENCIA cause weight gain? ›

No, Orencia doesn't cause weight gain. This side effect wasn't seen during studies of the drug. In fact, nausea is a common side effect of Orencia, and it may reduce your appetite. This could lead to weight loss.

Does ORENCIA suppress the immune system? ›

Orencia (Abatacept) is a biologic medication used to treat rheumatoid arthritis, as well as some other types of arthritis. Orencia is a synthetic protein that suppresses the body's immune system. It prevents an important type of immune system cell, the T-cell, from turning on and becoming "activated".

Does ORENCIA cause sun sensitivity? ›

Photosensitivity may also be a serious side-effect of anti-TNF drugs such as Cimzia, Enbrel, Humira, Remicade, and Simponi, as well as sulfasalazine. It is not considered a side-effect of Actemra, Arava, Kineret, Orencia, or Rituxan.

Does Orencia reduce inflammation? ›

Abatacept (Orencia) is often prescribed after failure of a disease-modifying anti-rheumatic agent (DMARD), like methotrexate but it can be used as first-line therapy. Abatacept is used to reduce inflammatory symptoms such as swelling, pain, and stiffness.

What are the side effects of abatacept? ›

Abatacept may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
  • headache.
  • runny nose.
  • nausea.
  • diarrhea.
  • stomach pain.
  • dizziness.
  • heartburn.
  • back pain.
15 Aug 2022

What happens when you stop taking Orencia? ›

If you don't take it at all: If you don't take this medication your symptoms won't be controlled. You could have worse symptoms, such as bone or joint damage. If you don't take it on schedule: It's important to keep on schedule to ensure that the medication has the same effect on your symptoms and condition.

What is the newest treatment for psoriatic arthritis? ›

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (skyrizi) for the treatment of active psoriatic arthritis (PsA) in adults.

What is the safest medicine to take for psoriatic arthritis? ›

Nonsteroidal anti-inflammatory drugs (NSAIDs)

For both psoriasis and psoriatic arthritis, NSAIDs are a common first-line treatment. Typically available over the counter, NSAIDs include aspirin, ibuprofen (Advil), and naproxen sodium (Aleve). Your doctor may provide a prescription-strength NSAID if appropriate.

What is the first-line treatment for psoriatic arthritis? ›

First-line therapy in PsA includes the use of anti-inflammatory agents such as nonsteroidal anti-inflammatory drugs (NSAIDs) and at times low-dose prednisone given orally or by intra-articular glucocorticoid injections, always taking into account existing comorbidities, especially premature cardiovascular disease.

How long do you stay on biologics? ›

It should also be noted that treatment courses for each biologic agent varied, from 6 to 40 weeks of treatment. The treatment duration could have impacted the time to relapse, as many biologics are known to produce a sustained or improved response with longer treatment durations (Figure 3).

What is the least expensive biologic for psoriatic arthritis? ›

Infliximab is the least expensive biologic with the highest percentage of patients achieving PASI 75.

Is methotrexate safer than biologics? ›

Patients with plaque psoriasis taking apremilast, etanercept, and ustekinumab had a lower rate of serious infections than those who took methotrexate.

How effective is Orencia? ›

Effectiveness for rheumatoid arthritis

Orencia was given by IV infusion. Of those taking Orencia, 62% of people had at least a 20% reduction in their RA symptoms after 3 months of treatment.

What drugs interact with Orencia? ›

Some products that may interact with this drug include: anakinra, rituximab, TNF blocking agents (such as adalimumab, etanercept, infliximab).

How good is Orencia? ›

Orencia has an average rating of 6.1 out of 10 from a total of 57 ratings on Drugs.com. 46% of reviewers reported a positive experience, while 31% reported a negative experience.

Can ORENCIA affect the kidneys? ›

Orencia, like most of the biologics, does modestly increase the risk for infections. However, it is not associated with kidney stones.

Can ORENCIA cause neurological problems? ›

RA, which Orencia is used to treat, can cause neurological symptoms. These symptoms include peripheral neuropathy (nerve damage that causes numbness, weakness, and pain in your arms or legs). Some medications that treat conditions Orencia is used for can cause neurological side effects.

Can ORENCIA cause lymphoma? ›

In the cumulative intravenous ORENCIA clinical trials in patients with RA (placebo-controlled and uncontrolled, open-label) a total of 8 cases of lung cancer (0.21 cases per 100 patient-years) and 4 lymphomas (0.10 cases per 100 patient-years) were observed in 2688 patients (3827 patient-years).

Can Orencia cause depression? ›

And people with rheumatoid arthritis have a high risk of depression. So it's possible you may experience hair loss and depression while taking Orencia to treat these conditions. However, they're not necessarily caused by the drug. If you have hair loss or depression while taking Orencia, talk with your doctor.

What is abatacept target? ›

Abatacept is the only agent currently approved to treat rheumatoid arthritis (RA) that targets the co-stimulatory signal required for full T-cell activation.

Does Orencia raise blood sugar? ›

ORENCIA for intravenous infusion (given through a needle placed in a vein) contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of ORENCIA infusion.

Can ORENCIA cause lung problems? ›

You may experience breathing problems more often while taking ORENCIA. Call your healthcare provider if you experience any of the following: Worsened COPD. Cough.

How long has ORENCIA been on the market? ›

Orencia was first approved in the United States in December 2005 for the treatment of rheumatoid arthritis, and has been marketed in more than 50 countries around the world. The manufacturing and marketing approval for intravenous infusion was granted in Japan in July 2010.

Can you take prednisone with ORENCIA? ›

Interactions between your drugs

No interactions were found between Orencia and prednisone.

What's the difference between Humira and ORENCIA? ›

Orencia and Humira belong to different drug classes. Orencia is a recombinant DNA generated fusion protein and Humira is an injectable protein (antibody). Side effects of Orencia and Humira that are similar include headache, stomach pain, and cold symptoms such as stuffy head/nose, sneezing, sore throat, or cough.

What type of biologic is abatacept? ›

Introduction: Abatacept is a biologic drug that belongs to the class of T-cell co-stimulation modulators and is used for the treatment of rheumatoid arthritis (RA).

Is ORENCIA and methotrexate the same? ›

Otrexup (methotrexate) Calms down the immune system and prevents joint damage. Orencia (abatacept) slows the progress of rheumatoid arthritis, but can also cause serious side effects. Reduces inflammation and cell replication.

Can ORENCIA cause heart failure? ›

In a nutshell

This study investigated the risk of heart failure in patients treated with either etanercept (Enbrel) or abatacept (Orencia) for rheumatoid arthritis (RA). They found that these drugs do not increase the risk of heart failure.

What is abatacept made from? ›

Abatacept is a homodimeric fusion protein of two identical subunits covalently linked by one disulphide bond. Each subunit consists of amino acids similar to the extracellular domain of human cytotoxic lymphocyte associated antigen 4 (CTLA-4) and human immunoglobulin IgG1 hinge, CH2 and CH3 regions (Fc).

How long do you stay on biologics for psoriasis? ›

Most people have clearer skin within 3 to 4 months.

You may notice some decrease in psoriasis symptoms as soon as one week after starting the medication, but most of the benefits will be seen around 12 weeks.

Can biologics make arthritis worse? ›

Talk to Your Doctor

Stopping biologics could make your arthritis flare. A relapse not only affects your quality of life, but could also lead to more joint-damaging inflammation, Ghosh says. If your symptoms haven't improved on your biologic, or if you're having side effects, you do have other options, Haberman says.

Is psoriatic arthritis worse than RA? ›

A study published in 2015 in the journal PLoS One found that the overall pain, joint pain, and fatigue reported by psoriatic arthritis patients was significantly greater than that reported by people with rheumatoid arthritis.

What drugs reduce PsA levels? ›

Two of the most common classes of medication — statins and nonsteroidal anti-inflammatory drugs (NSAIDs) — may compromise cancer screenings by lowering serum prostate-specific antigen (PSA) levels, according to two studies.

What happens if psoriatic arthritis is not treated? ›

If left untreated, psoriatic arthritis (PsA) can cause permanent joint damage, which may be disabling. In addition to preventing irreversible joint damage, treating your PsA may also help reduce inflammation in your body that could lead to other diseases. These other diseases are often referred to as comorbidities.

Does psoriatic arthritis get progressively worse? ›

Is psoriatic arthritis progressive? Meaning: Does it get worse over time (particularly without adequate treatment)? For many patients, the answer can be yes, but the course of disease is not always straightforward.

What foods to avoid if you have psoriatic arthritis? ›

Foods like fatty red meats, dairy, refined sugars, processed foods, and possibly vegetables like potatoes, tomatoes, and eggplants (you might hear them called nightshades) may all cause inflammation. Avoid them and choose fish, like mackerel, tuna, and salmon, which have omega-3 fatty acids.

What is the most effective drug for psoriatic arthritis? ›

Conventional DMARDs .

These drugs can slow the progression of psoriatic arthritis and save joints and other tissues from permanent damage. The most commonly used DMARD is methotrexate (Trexall, Otrexup, others). Others include leflunomide (Arava) and sulfasalazine (Azulfidine).

What are the six signs of psoriatic arthritis? ›

Here are six symptoms you should watch out for.
  • It's hard to move in the morning. ...
  • Your fingers look like warm sausages. ...
  • You have lower back pain. ...
  • Your nails have grooves and ridges. ...
  • You experience eye problems. ...
  • You're always tired.
22 Jul 2021

What are the 5 types of psoriatic arthritis? ›

Psoriatic arthritis is categorized into five types: distal interphalangeal predominant, asymmetric oligoarticular, symmetric polyarthritis, spondylitis, and arthritis mutilans. The distal interphalangeal predominant type affects mainly the ends of the fingers and toes.

What is Orencia used for? ›

ORENCIA is used to reduce signs and symptoms of moderate to severe Rheumatoid Arthritis in adults 18 years and older. Taking ORENCIA may prevent further damage to your bones and joints, and may help your ability to perform daily activities.

What are the side effects of Orencia? ›

Common side effects of Orencia include:
  • headache,
  • nausea,
  • diarrhea,
  • stomach pain,
  • indigestion,
  • dizziness,
  • flushing,
  • back pain, or.

Does Tremfya help psoriatic arthritis? ›

In two medical studies, more than 5 out of 10 patients treated with TREMFYA® had at least a 20% improvement in active PsA symptoms (joint pain, stiffness, swelling) at 24 weeks compared to placebo. Learn how TREMFYA® can help adults with active psoriatic arthritis. Already have a TREMFYA® prescription?

Is Orencia a biologic drug? ›

Orencia (abatacept) is an injectable biologic drug that slows joint damage and reduces pain in rheumatoid arthritis and other autoimmune diseases. It's in a class of medications called immunomodulators or selective costimulation modulators.

Does Orencia weaken the immune system? ›

Serious infections. You may have a higher risk of serious infections while you're taking Orencia. This is because the drug makes your immune system less able to protect you from infections. In clinical studies, 54% of people taking Orencia had infections.

Does Orencia reduce inflammation? ›

Abatacept (Orencia) is often prescribed after failure of a disease-modifying anti-rheumatic agent (DMARD), like methotrexate but it can be used as first-line therapy. Abatacept is used to reduce inflammatory symptoms such as swelling, pain, and stiffness.

How good is Orencia? ›

Orencia has an average rating of 6.1 out of 10 from a total of 57 ratings on Drugs.com. 46% of reviewers reported a positive experience, while 31% reported a negative experience.

How good is abatacept? ›

Abatacept has an average rating of 6.2 out of 10 from a total of 59 ratings on Drugs.com. 48% of reviewers reported a positive experience, while 30% reported a negative experience. Reviews may be edited to correct grammar/spelling or to remove inappropriate language and content.

Does ORENCIA make you gain weight? ›

Is weight gain a side effect of Orencia treatment? No. People using Orencia in clinical studies didn't report weight gain as a side effect. Weight gain can be a side effect of certain medications that treat some of the same conditions as Orencia.

Can ORENCIA affect the kidneys? ›

Orencia, like most of the biologics, does modestly increase the risk for infections. However, it is not associated with kidney stones.

How quickly does TREMFYA work psoriatic arthritis? ›

Official answer. It takes about 16 weeks for Tremfya to start working in most people, which is two doses of Tremfya because each dose is given 8 weeks apart.

How quickly does Taltz work for psoriatic arthritis? ›

Some patients felt joint symptom relief in as early as 1 week. Individual results may vary. Of all the patients taking Taltz who achieved joint symptom improvement at 6 months, more than half maintained those results at 3 years with continued treatment.

What is psoriatic arthritis caused from? ›

Psoriatic arthritis occurs when your body's immune system attacks healthy cells and tissue. The immune response causes inflammation in your joints as well as overproduction of skin cells. It seems likely that both genetic and environmental factors play a role in this immune system response.

Does ORENCIA cause sun sensitivity? ›

Photosensitivity may also be a serious side-effect of anti-TNF drugs such as Cimzia, Enbrel, Humira, Remicade, and Simponi, as well as sulfasalazine. It is not considered a side-effect of Actemra, Arava, Kineret, Orencia, or Rituxan.

Can ORENCIA cause eye problems? ›

During your Orencia treatment, call your doctor right away if you experience seizures, changes in vision or hearing, or feelings of numbness or weakness. Your doctor may order tests to find the cause.

What is abatacept target? ›

Abatacept is the only agent currently approved to treat rheumatoid arthritis (RA) that targets the co-stimulatory signal required for full T-cell activation.

Videos

1. Expert Recommendations from EULAR on Psoriatic Arthritis/Ankylosing Spondylitis/Miscellaneous
(ClevelandClinicCME)
2. Clinical Assessment and Principles of Management of Psoriatic Arthritis
(ClevelandClinicCME)
3. Head-to-Head Comparison of SC Abatacept Versus Adalimumab on Background Methotrexate in RA...
(ProjectsInKnowledge)
4. Biologics in PsA and SpA
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5. Secukinumab in patients with psoriatic arthritis and axial manifestations
(Annals of the Rheumatic Diseases)
6. Update in Treatment of Psoriatic Arthritis
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