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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.

Efficacy results from AGREE, a pivotal trial of 509 adult patients with rapidly progressing RA with poor prognostic factors1,2

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

AGREE: A Pivotal Trial

A 12-month, phase IIIb, multinational, double-blind, randomized study of MTX-naïve patients with moderate to severe RA1*

PATIENTS1

AGREE Study Design | ORENCIA® (abatacept)

 

ORENCIA IV was administered on days 1, 15, 29, and every 4 weeks thereafter.
*Or prior exposure to MTX ≤10mg/week for ≤3 weeks with none administered for 3 months prior to enrollment.

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

*Or prior exposure to MTX ≤10mg/week for ≤3 weeks with none administered for 3 months prior to enrollment.

KEY PATIENT DISEASE CHARACTERISTICS1

MEAN DISEASE
DURATION
6.5 MONTHS
ANTI-CCP+ 89% OF PATIENTS
RF+ 96.5% OF PATIENTS
MEAN
DAS28-CRP
6.3
JOINT EROSIONS 100% OF PATIENTS

Radiographic evidence of bone erosion of the hands, wrists, and feet.

INCLUSION CRITERIA1

  • Early (≤2 years) and active RA according to ACR criteria
  • ≥18 years old
  • MTX-naïve or MTX ≤10 mg/week for ≤3 weeks and no dose for 3 months prior to enrollment
  • ≥12 tender and ≥10 swollen joints
  • CRP ≥0.45 mg/dL
  • RF and/or anti-CCP2 seropositivity
  • Radiographic evidence of bone erosion of the hands, wrists, and feet

PRIMARY ENDPOINTS1

  • Proportion of patients achieving DAS28-CRP <2.6 at 12 months
  • Radiographic progression measured by Genant-modified TSS at 12 months

SELECTED SECONDARY ENDPOINTS1

  • ACR 50 response at 12 months
  • Major clinical response (ACR 70 for ≥6 consecutive months) at 12 months
  • Proportion of patients achieving a ≥0.3 improvement in HAQ-DI at 12 months
  • Anti-CCP2: Anti-cyclic citrullinated peptide 2.
  • CRP: C-reactive protein.
  • DAS: Disease activity score.
  • HAQ-DI: Health Assessment Questionnaire-Disability Index.
  • RF: Rheumatoid factor.
  • TSS: Total Sharp score.

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.

ORENCIA IV + MTX achieved minimal disease activity (DAS28-CRP <2.6) vs MTX alone

AGREE STUDY: CO-PRIMARY ENDPOINT1-3

DAS28-CRP <2.6 OF ORENCIA IV + MTX VS
MTX ALONE AT 1 YEAR

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.

STUDY DESIGN2

AGREE Study: A 12-month, phase lllb, multinational, double-blind, randomized, placebo-controlled study of 509 adult patients with moderate to severe RA who were MTX-naïve or had an inadequate response to MTX. For more information, please see the Study Design tab above.

ORENCIA provided significant inhibition of radiographic progression in patients with rapidly progressing RA

AGREE STUDY: CO-PRIMARY ENDPOINT1,2

ORENCIA IV + MTX SIGNIFICANTLY INHIBITED RADIOGRAPHIC PROGRESSION AT 1 YEAR VS
MTX ALONE

Treating the Patient with Rapidly Progressing RA

TSS, total Sharp score.

61% of patients had no detectable evidence of radiographic progression (TSS ≤0) with ORENCIA IV + MTX at 1 year vs 53% with MTX alone2

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.

STUDY DESIGN1

AGREE Study: A 12-month, phase lllb, multinational, double-blind, randomized, placebo-controlled study of 509 adult patients with moderate to severe RA who were MTX-naïve or had an inadequate response to MTX. For more information, please see the Study Design tab above.

ORENCIA IV + MTX achieved clinically meaningful HAQ-DI improvements (≥0.3) for patients with rapidly progressing RA

AGREE STUDY: SECONDARY ENDPOINT2,3

ORENCIA IV + MTX DEMONSTRATED
SIGNIFICANT HAQ-DI IMPROVEMENTS (≥0.3) AT
1 YEAR VS MTX ALONE

Treating the Patient with Rapidly Progressing RA

HAQ-DI, Health Assessment Questionnaire-Disability Index.

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.

STUDY DESIGN1

AGREE Study: A 12-month, phase llb, multinational, double-blind, randomized, placebo-controlled study of 509 adult patients with moderate to severe RA who were MTX-naïve or had an inadequate response to MTX. For more information, please see the Study Design tab above.

ORENCIA IV + MTX significantly improved symptom relief for patients with rapidly progressing RA

AGREE STUDY: SECONDARY ENDPOINT1-3

ORENCIA IV + MTX SIGNIFICANTLY IMPROVED THE ACR 70 RESPONSE RATE AT 1 YEAR VS MTX ALONE

Treating the Patient with Rapidly Progressing RA

SECONDARY ENDPOINTS1-3

Major clinical response: Proportion of patients who maintained an ACR 70 response for a continuous period of at least 6 consecutive months (P<0.001)

 

• 27% ORENCIA IV + MTX  
• 12% Placebo + MTX

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.

STUDY DESIGN1

AGREE Study: A 12-month, phase lllb, multinational, double-blind, randomized, placebo-controlled study of 509 adult patients with moderate to severe RA who were MTX-naïve or had an inadequate response to MTX. For more information, please see the Study Design tab above.

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

LEARN MORE

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. Westhovens R, Robles M, Ximenes AC, et al. Clinical efficacy and safety of abatacept in methotrexate-naïve patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis. 2009;68(12):1870-1877. 2. ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb. 3. Data on File. ABAT 032. Princeton, NJ: Bristol-Myers Squibb.