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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).

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.

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

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.

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

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.

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Indications and Usage

Juvenile Idiopathic Arthritis (JIA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular JIA. ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX).

Important Limitations of Use: ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

Results from the AMPLE 2-Year Study, a head-to-head noninferiority study of 646 biologic-naïve moderate to severe RA patients1

  • STUDY
    DESIGN
  • SYMPTOM
    RELIEF
  • DISEASE
    ACTIVITY
  • RADIOGRAPHIC
    PROGRESSION
  • PHYSICAL
    FUNCTION

AMPLE 2-Year Study: A head-to-head noninferiority study of ORENCIA vs adalimumab1,2

The AMPLE 2-Year Study is a multinational, prospective, randomized, Phase IIIb study of adult MTX-IR, biologic-naïve moderate to severe RA patients.1

The AMPLE study is not contained within the Full Prescribing Information. It is a supportive clinical trial to the ORENCIA registrational trial, AGREE, which was a 12-month, multinational, double-blind, randomized, Phase IIIb study of MTX-naïve patients with moderate to severe RA. However, these trials had different comparators.

For information on AGREE, please see the Full Prescribing Information.

KEY PATIENT DISEASE CHARACTERISTICS1,2

  ORENCIA +
MTX (n=318)
adalimumab +
MTX (n=328)
Mean disease duration 1.9 years 1.7 years
Anti-CCP+* 45% 47%
RF+ 75.5% 77.4%
Mean DAS28-CRP 5.5 5.5
Joint erosion 93% 96%

*Anti-CCP+ status was reported by patient’s medical history for 488 of the 646 patients.2

Seropositive for RF antibodies as reported by patient's medical history.

Radiographic evidence of joint erosion.

INCLUSION CRITERIA3,4

  • ≥18 years of age with moderate to severe active RA for ≤5 years
  • Inadequate response to MTX and biologic naïve
  • ≥3.2 DAS28-CRP and a history of one or more of the following
    • Seropositivity for anti-CCP or RF
    • If seronegative for anti-CCP and RF, patients had to have an elevated ESR or CRP level

Anti-CCP, anti-cyclic citrullinated peptide; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; MTX-IR, inadequate responders to methotrexate; RF, rheumatoid factor (as reported by patient’s medical history).

KEY EXCLUSION CRITERIA4

  • Previous treatment with an investigational or approved biologic for RA
  • History of active or chronic hepatitis B
  • Subjects with any other rheumatic disease or with active vasculitis of a major organ

PRIMARY ENDPOINT1,3

  • Noninferiority of ORENCIA SC vs adalimumab SC, assessed by ACR 20 at 1 year

SELECTED SECONDARY ENDPOINTS1,3

  • ACR (20, 50, 70) scores through 2 years
  • Proportion of patients achieving DAS28-CRP <2.6 through 2 years
  • Proportion of patients achieving a ≥0.3 improvement from baseline in HAQ-DI through 2 years
  • Radiographic nonprogression at Year 1 and Year 2 as measured by change in total modified Sharp score

LIMITATIONS OF THE STUDY1

Double-blinding for the study drugs was not feasible due to the difficulty masking the adalimumab administration. Patients were not blinded with regard to study drug. To mitigate this limitation, the study used clinical assessors and radiographic readers, who were blinded with regards to each patient’s treatment.

The Important Safety Information is derived from the clinical trial safety data contained within the Full Prescribing Information.

Selected Important Safety Information

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 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.

ORENCIA ACR results were comparable to adalimumab in biologic-naïve moderate to severe RA patients1

At baseline in the AMPLE 2-Year Study, 75.5% of ORENCIA SC + MTX patients and 77.4% of adalimumab SC + MTX patients were RF+; 45% of ORENCIA SC + MTX patients and 47% of adalimumab SC + MTX patients were anti-CCP+.1-3

Anti-CCP, anti-cyclic citrullinated peptide; MTX-IR, inadequate responders to methotrexate; RF, rheumatoid factor.

AMPLE 2-YEAR STUDY: PRIMARY ENDPOINT

Noninferiority as measured by ACR 20 at 1 year was achieved: ORENCIA SC + MTX 64.8% (95% CI, 59.5% to 70.0%) relative to adalimumab SC + MTX 63.4% (95% CI, 58.2% to 68.6%).2

The percentage of patients achieving ACR 20 at 2 years was 59.7% for ORENCIA SC + MTX (95% Cl, 54.4% to 65.1%) and 60.1% for adalimumab SC + MTX (95% Cl, 54.8% to 65.4%).1

ACR Results1

Selected Important Safety Information

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. 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.

STUDY DESIGN1,3

AMPLE 2-Year Study: A 2-year, multinational, prospective, randomized, Phase IIIb study of 646 adult MTX-IR, biologic-naïve moderate to severe RA patients. For more information, please see the Study Design tab above.

ORENCIA DAS28-CRP <2.6 results were comparable to adalimumab in biologic-naïve moderate to severe RA patients1,2

At baseline in the AMPLE 2-Year Study, 75.5% of ORENCIA SC + MTX patients and 77.4% of adalimumab SC + MTX patients were RF+; 45% of ORENCIA SC + MTX patients and 47% of adalimumab SC + MTX patients were anti-CCP+.1-3

AMPLE 2-Year Study: SECONDARY ENDPOINT

50.6% of patients taking ORENCIA SC + MTX (95% CI, 44.4% to 56.8%) achieved minimal disease activity (DAS28-CRP <2.6) at 2 years.1

CRP, C-reactive protein; DAS, Disease Activity Score.

DAS28-CRP <2.6 Results1,2

Selected Important Safety Information

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.

STUDY DESIGN1,3

AMPLE 2-Year Study: A 2-year, multinational, prospective, randomized, Phase IIIb study of 646 adult MTX-IR, biologic-naïve moderate to severe RA patients. For more information, please see the Study Design tab above.

ORENCIA radiographic results were comparable to adalimumab in biologic-naïve moderate to severe RA patients as
measured by modified total Sharp score1*

At baseline in the AMPLE 2-Year Study, 75.5% of ORENCIA SC + MTX patients and 77.4% of adalimumab SC + MTX patients were RF+; 45% of ORENCIA SC + MTX patients and 47% of adalimumab SC + MTX patients were anti-CCP+.1-3

AMPLE 2-Year Study: SECONDARY ENDPOINT

At Year 1, 87.8% (95% CI, 84.1% to 91.5%) of ORENCIA SC + MTX patients demonstrated no change in TSS from baseline.4

At Year 2, 84.8% (95% CI, 80.4% to 89.2%) of ORENCIA SC + MTX patients demonstrated no change in TSS from baseline.1

RADIOGRAPHIC RESULTS1

TSS, total Sharp score. Nonprogression was assessed using the modified Sharp/van der Heijde scoring system and was defined as ≤ the smallest detectable change.

*Based on readings at Year 1, the percentage of radiographic nonprogressors was 84.8% for ORENCIA and 88.6% for adalimumab. Graph shown is based on 2-year readings.

Selected Important Safety Information

Immunizations: Prior to initiating ORENCIA in 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.

STUDY DESIGN1,3

AMPLE 2-Year Study: A 2-year, multinational, prospective, randomized, Phase IIIb study of 646 adult MTX-IR, biologic-naïve moderate to severe RA patients. For more information, please see the Study Design tab above.

ORENCIA HAQ-DI results were comparable to adalimumab in biologic-naïve moderate to severe RA patients1

At baseline in the AMPLE 2-Year Study, 75.5% of ORENCIA SC + MTX patients and 77.4% of adalimumab SC + MTX patients were RF+; 45% of ORENCIA SC + MTX patients and 47% of adalimumab SC + MTX patients were anti-CCP+.1-3

AMPLE 2-Year Study: SECONDARY ENDPOINT

54.1% of patients taking ORENCIA SC + MTX (95% CI, 48.6% to 59.6%) achieved a HAQ-DI improvement of ≥0.3 at 2 years.1,2

HAQ-DI RESULTS1

HAQ-DI, Heath Assessment Questionnaire-Disability Index.

Selected Important Safety Information

Use 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.

STUDY DESIGN1,3

AMPLE 2-Year Study: A 2-year, multinational, prospective, randomized, Phase IIIb study of 646 adult MTX-IR, biologic-naïve moderate to severe RA patients. For more information, please see the Study Design tab above.

More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

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 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.

Use 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.

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: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

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.

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.

Please click here for Full Prescribing Information »

 More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

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 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.

Use 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.

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: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

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.

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.

Please see Full Prescribing Information »

References:

  • Schiff M, Weinblatt ME, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: two-year efficacy and safety findings from AMPLE trial. Ann Rheum Dis. 2014;73(1):86-94.
  • Data on File. ABAT 143. Princeton, NJ: Bristol-Myers Squibb.
  • Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. 2013;65(1):28-38.
  • Data on File. ABAT 142. Princeton, NJ: Bristol-Myers Squibb.