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Indication and Usage

Adult Rheumatoid Arthritis (RA): ORENCIA® (abatacept) is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

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.

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Indication 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.

IN MODERATE TO SEVERE RA

Sustained results in
MTX-inadequate responders

ORENCIA demonstrated efficacy in 2 double-blind studies, 101-100 and AIM, with open-label extensions1,2

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

101-100: 1 year + 2-year open-label extension

A 6-month, phase II, double-blind, randomized, placebo-controlled study1-3

PATIENTS1

Treating the Patient with Rapidly Progressing RA Treating the Patient with Rapidly Progressing RA

ORENCIA was administered on days 1, 15, and 29 and every 4 weeks thereafter. All patients remained on MTX and were permitted to add another DMARD (hydroxychloroquine, sulfasalazine, gold, or azathioprine) at 6 months.1,4

INCLUSION CRITERIA1

  • ≥18 years old with active RA for ≥1 year
  • Treated with MTX (10-30 mg/week) for ≥6 months, with a stable dose for 28 days prior to enrollment
  • Mandatory washout of all other DMARDs at least 28 days before enrollment
  • Active disease with ≥10 swollen joints, ≥12 tender joints
  • C-reactive protein (CRP) levels of ≥1 mg/dL at randomization

PRIMARY ENDPOINTS1

  • ACR 20 response at 6 months in the 10 mg/kg treatment arm

OPEN-LABEL PERIOD4

  • ACR 20, 50, and 70 responses over 3 years
  • HAQ-DI over 3 years

SCROLL FOR AIM STUDY DESIGN

Selected Important Safety Information

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

 

AIM: 1 year + 1-year open-label extension2

A 12 month, phase IIIb, randomized, multinational, double-blind, placebo-controlled study

PATIENTS2

Treating the Patient with Rapidly Progressing RA

ORENCIA was administered on days 1, 15, and 29 and every 4 weeks thereafter

INCLUSION CRITERIA2

  • ≥18 years old with active RA ≥1 year
  • Met ACR criteria for RA
  • Treated with MTX (≥15 mg/week) for 3 months or longer, with a stable dose for 28 days
  • Mandatory washout of all other DMARDs at least 28 days before randomization
  • ≥10 swollen joints, ≥12 tender joints
  • C-reactive protein (CRP) levels of ≥10.0 mg/L at randomization

PRIMARY ENDPOINTS2

  • Proportion of patients achieving an ACR 20 reponse at 6 months
  • Erosion score at 12 months based on Genant-modified Sharp score
  • Proportion of patients achieving a ≥0.3 improvement from baseline in HAQ-DI at 12 months

SECONDARY ENDPOINTS2

  • ACR 50 and ACR 70 responses at 6 months
  • ACR 20, ACR 50, and ACR 70 responses at 12 months
  • Major clinical response (ACR 70 for ≥6 consecutive months) at 12 months
  • Disease Activity Score-28 (DAS28) at 6 and 12 months

OPEN-LABEL PERIOD5

  • Radiographic data at 2 years

CRP, C-reactive protein.
HAQ-DI, Health Assessment Questionnaire-Disability Index.
TSS, total Sharp score.

Selected Important Safety Information

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid 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, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. 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 ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

ORENCIA maintained inhibition of radiographic progression over 2 years

AIM STUDY: CO-PRIMARY ENDPOINTS AND OTHER ENDPOINTS2,6

CHANGE IN EROSION SCORE AT 1 YEAR (CO‑PRIMARY ENDPOINT) AND 2 YEARS (OPEN‑LABEL EXTENSION)

CHANGE IN EROSION SCORE AT 1 YEAR (CO‑PRIMARY ENDPOINT) AND 2 YEARS (OPEN‑LABEL EXTENSION)

Treating the Patient with Rapidly Progressing RA

Inhibit further joint damage—51% of patients had no detectable progression of structural damage after 2 years of treatment with ORENCIA IV + MTX (defined as ≤0 change in TSS)6

STUDY DESIGN2

AIM: A 12-month, phase lll, randomized, multicenter, multinational, double-blind, placebo-controlled study of 652 adult patients with moderate to severe RA who had an inadequate response to MTX. For more information, please see the Study Design tab above.

TSS, total Sharp score.

Selected Important Safety Information

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. 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.

101-100 Study

ORENCIA IV + MTX maintained improvements in physical function (HAQ-DI) over 3 years7*

101-100 STUDY: OTHER ENDPOINTS

PROPORTION OF PATIENTS WHO ACHIEVED ≥0.3 IMPROVEMENT IN HAQ-DI OVER 3 YEARS

Treating the Patient with Rapidly Progressing RATreating the Patient with Rapidly Progressing RA

*The same patients may not have responded at each time point.
Data are based on an as-observed analysis performed on data available at the visit of interest without imputation.

STUDY DESIGN3,4

101-100: A 12-month, multicenter, randomized, double-blind, placebo-controlled study of 339 patients with active RA who had inadequate response to MTX. Patients were randomly assigned to receive ORENCIA IV 2 mg/kg + MTX (n=105), ORENCIA IV 10 mg/kg + MTX (n=115), or placebo + MTX (n=119). After completion of the double-blind period, patients were given the option to enter a 12-month open-label extension period. All patients in the open-label period received ORENCIA IV 10 mg/kg + MTX. For more information, please see the Study Design tab above.

SCROLL FOR AIM HAQ-DI RESULTS

Selected Important Safety Information

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations.

 

AIM STUDY

AIM STUDY: CO-PRIMARY ENDPOINT2,7

PROPORTION OF PATIENTS WHO ACHIEVED ≥0.3 HAQ-DI IMPROVEMENT VS PLACEBO + MTX OVER 1 YEAR

Treating the Patient with Rapidly Progressing RA

HAQ-DI, Health Assessment Questionnaire-Disability Index.

STUDY DESIGN2

AIM: A 12-month, multinational, multicenter, randomized, double-blind, placebo-controlled, phase III study of 652 adult patients with moderate to severe RA who had an inadequate response to MTX. For more information, please see the Study Design tab above.

Selected Important Safety Information

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). 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 RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

ACR responses were maintained through 3 years in the 101-100 open-label extension study of MTX-inadequate responders

101-100 STUDY: OTHER ENDPOINTS

PROPORTION OF PATIENTS WHO ACHIEVED ACR 20/50/70 RESPONSES OVER 3 YEARS*

Treating the Patient with Rapidly Progressing RA Treating the Patient with Rapidly Progressing RA

*The same patients may not have responded at each time point.
Data are based on an as-observed analysis performed on data available at the visit of interest.

STUDY DESIGN3,4

101-100: A 6-month, phase ll, double-blind, randomized, placebo-controlled study of 339 patients with active RA who had inadequate response to MTX. Patients were randomly assigned to receive ORENCIA IV 2 mg/kg + MTX (n=105), ORENCIA IV 10 mg/kg + MTX (n=115), or placebo + MTX (n=119). After completion of the double-blind period, patients were given the option to enter a 12-month open-label extension period. All patients in the open-label period received ORENCIA IV 10 mg/kg + MTX. For more information, please see the Study Design tab above.

SCROLL FOR AIM ACR RESULTS

Selected Important Safety Information

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.

 

ORENCIA provided powerful symptom relief as measured by ACR

AIM STUDY: OTHER ENDPOINTS1,2

ORENCIA IV + MTX DEMONSTRATED SIGNIFICANT ACR 20/50/70 RESPONSES AT 1 YEAR VS MTX ALONE

Treating the Patient with Rapidly Progressing RA
STUDY DESIGN2

AIM: A 12-month, phase lll, multicenter, multinational, double-blind, placebo-controlled, randomized study of 652 adult patients with moderate to severe RA who had an inadequate response to MTX. For more information, please see the Study Design tab above.

Selected Important Safety Information

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.

In moderate to severe RA
Treating the patient with rapidly progressing RA

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Model—not an actual patient

More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid 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 JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. 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 ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. 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: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). 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 RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

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 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 JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.

Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJectTM Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

Please see Full Prescribing Information »

 More Important
Safety Information

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63%) and serious infections (4.4%) compared to patients treated with only TNF antagonists (43% and 0.8%, respectively), without an important enhancement of efficacy.

Hypersensitivity: Anaphylaxis or anaphylactoid reactions can occur during or after an infusion and can be life-threatening. There were 2 cases (<0.1%; n=2688) of anaphylaxis or anaphylactoid 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 JIA clinical trials (0.5%; n=190). In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA was reported. 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 ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, have been reported in patients receiving ORENCIA. 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: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation. The efficacy of vaccination in patients receiving ORENCIA is not known. ORENCIA may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). 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 RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

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 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 JIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric patients were similar in frequency and type to those seen in adult patients.

Note concerning ORENCIA administration options: Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of ORENCIA ClickJectTM Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

Please see Full Prescribing Information »

References: 1. Kremer JM, Westhovens R, Leon M, et al. Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med. 2003;349(20):1907-1915. 2. Kremer JM, Genant HK, Moreland LW, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006;144(12):865-876. 3. Data on File. ABAT 071. Princeton, NJ: Bristol-Myers Squibb. 4. Kremer JM, Dougados M, Emery P, et al. Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept. [published correction appears in Arthritis Rheum. 2005;52(10):3321]. Arthritis Rheum. 2005;52(8):2263-2271. 5. Kremer JM, Russell AS, Emery P, et al. Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis. 2011;70(10):1826-1830. 6. ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb. 7. Data on File. ABAT 119. Princeton, NJ: Bristol-Myers Squibb.