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Indications 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.

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.

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

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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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.

ORENCIA Is Indicated for Adult Patients With Active Psoriatic Arthritis1

Identifying Patients With Active Psoriatic Arthritis (PsA)

Patients with active PsA may experience a largely musculoskeletal disease course involving joint erosion/damage, enthesitis, dactylitis, tenderness and swelling, and may present with skin lesions. Irreversible joint damage and PsA progression begin within the first 2 years after disease onset.1-4

psoriatic arthritis patients may exhibit joint erosion and damage in elbows, neck, ankles, toes, knees, shoulders, wrists, and/or handspsoriatic arthritis patients may exhibit joint erosion and damage in elbows, neck, ankles, toes, knees, shoulders, wrists, and/or hands

Patients may present with:

    • Worsening symptoms2
    • Synovitis2,4
    • Dactylitis2,4
    • Enthesitis2,4
    • Skin lesions1

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.

Study Design1,2

ASTRAEA: A 24-week, Phase III, multicenter, double-blind, randomized study of ORENCIA SC (125 mg) with an open-label extension up to 24 months.

ASTRAEA Study DesignASTRAEA Study Design

ASTRAEA (PsA-II) Study Details1,2

STUDY DESIGN

  • Patients were randomized 1:1 to ORENCIA SC (125 mg once/week without loading dose) or placebo for 24 weeks, followed by open-label ORENCIA 125 mg SC weekly
  • Randomization was stratified by MTX use (60.4% of patients), prior TNFi use (61% of patients), and skin lesions (≥3% of body surface area)
  • Treatment arms: ORENCIA SC (n=213), placebo SC (n=211)
  • Patients not achieving ≥20% improvement in swollen and tender joint counts by Week 16 were switched to open-label ORENCIA SC
  • Patients could receive stable doses of concomitant MTX, sulfasalazine, leflunomide, hydroxychloroquine, low-dose corticosteroids (equivalent to ≤10 mg of prednisone), and/or nonsteroidal anti-inflammatory drugs

KEY PATIENT BASELINE CHARACTERISTICS1,2

  • 424 patients with active PsA
  • Limited skin lesions with ≥3% of BSA
  • Baseline PASI of 7.4 for ORENCIA and 7.2 for placebo
  • 61% of patients had prior exposure to TNF inhibitors
  • Mean disease duration of 8.5 (8.2) years
  • 51 years of age (mean)

KEY INCLUSION CRITERIA1,2

  • ≥3 tender and ≥3 swollen joints
  • ≥2 cm target lesion of plaque psoriasis
  • Inadequate response or intolerance to ≥1 nonbiologic DMARD

TREATMENT ARMS1,2

ORENCIA SC (n=213)

Placebo (n=211)

PRIMARY ENDPOINT1,2

ACR 20 response at Week 24

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. 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.

KEY PATIENT BASELINE
CHARACTERISTICS2*

Key patient baseline characteristics Key patient baseline characteristics
  • 61% of patients had prior exposure to TNF inhibitors
    • 44% had prior exposure to 1 TNF inhibitor; 16% to 2 TNF inhibitors, and 1% to ≥3 TNF inhibitors
  • 84% of patients had the presence of joint erosion on radiograph

*Data are presented as mean (SD) unless indicated otherwise.

PsA-I (IV): A dose-ranging study; 170 patients received study drug IV at Day 1, 15, 29, and then every 28 days thereafter in a double-blind manner for 24 weeks, followed by open-label ORENCIA IV every 28 days

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.

ORENCIA Improved Signs and Symptoms
in Patients With Active PsA1

IN THE ASTRAEA 24-WEEK, PHASE III STUDY

WITH ORENCIA, SIGNIFICANTLY MORE PATIENTS ACHIEVED THE PRIMARY ENDPOINT OF AN ACR 20 RESPONSE COMPARED WITH PLACEBO.1

ASTRAEA Trial Results ASTRAEA Trial Results
  • The proportion of patients with a decrease of ≥0.35 from baseline HAQ-DI on ORENCIA was 31%, compared with 24% on placebo
  • ORENCIA demonstrated the ability to induce complete resolution of enthesitis and dactylitis in 32.9% and 44.3% of patients (versus placebo, 21.2% and 34.0%, respectively)2
  • There was a numerical increase in the proportion of PASI 50 responders with ORENCIA compared with placebo: 26.7% versus 19.6% (estimated difference [95% CI], 7.3 [-2.2 to 16.7]; nominal P=0.137)2

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. 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.

The Safety Profile Was Comparable Between Studies PsA-I (IV) and PsA-II (SC) and Consistent With the Safety Profile In RA1

Once-weekly subcutaneous injection Double Blind Period*
ORENCIA SC
(n=213)
Placebo
(n=211)
Deaths 0 0
SAEs 6 (2.8) 9 (4.3)
Leading to discontinuation 3 (1.4) 3 (1.4)
AEs 116 (54.5) 112 (53.1)
Leading to discontinuation 3 (1.4) 4 (1.9)
AEs reported in ≥5% of patients
Nasopharyngitis 9 (4.2) 11 (5.2)
Upper RTI 6 (2.8) 14 (6.6)
Bronchitis 7 (3.3) 5 (2.4)
AEs of special interest
Infections 57 (26.8) 63 (29.9)
Malignancies 0 2 (0.9)
Autoimmune events 0 0
Local ISR 1 (0.5) 1 (0.5)

Data are presented as n (%) of patients. Investigators were instructed not to report psoriasis or PsA as AEs unless they were new forms of psoriasis or SAEs.

*Includes data up to 56 days after the last dose in the double-blind period or the first dose in the open-label period, whichever occurred first.

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

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 adult PsA patients were similar in frequency and type to those seen in adult RA patients.



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, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and 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 adult RA 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.

ORENCIA Offers Flexibility With 3 Available Administration Options1

Patients switching from ORENCIA IV therapy to ORENCIA SC should administer the first SC dose instead of the next scheduled IV dose.

ORENCIA can be used with or without non-biologic DMARDs.

ORENCIA IV Is a 30-minute Infusion1

DOSING SCHEDULE

Dosing schedule

Every 4 weeks thereafter

Actual day of dosing may vary based on patient scheduling. After the initial dose, ORENCIA IV should be administered at 2 and 4 weeks, then every 4 weeks thereafter.
Any unused portions in the vials must be immediately discarded.

ORENCIA injection vial

ADULT WEIGHT-BASED DOSING

Each vial contains 250 mg of ORENCIA. The appropriate dose may require 2, 3, or 4 vials based on patient weight.

ORENCIA SC allows patients once-weekly self-injection at home1

ORENCIA SC MAY BE INITIATED WITHOUT AN IV LOADING DOSE.

125-mg injection is supplied in a prefilled syringe with BD UltraSafe PassiveTM Needle Guard (safety syringe device).

ORENCIA subcutaneous (SC) device ORENCIA subcutaneous (SC) device

ORENCIA ClickJectTM Autoinjector—automatically delivers the full dose with one push of a button1,2

ORENCIA SC MAY BE INITIATED WITHOUT AN IV LOADING DOSE.

Push-button operation and injection confirmation may reduce the possibility of administration errors.

ORENCIA ClickJect Autoinjector ORENCIA ClickJect Autoinjector

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.

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 RA 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, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and 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 adult RA 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 RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA 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 JIA and adult PsA patients were similar in frequency and type to those seen in adult RA 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 click here for 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 RA 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, including COPD exacerbations, cough, rhonchi, and dyspnea. In adult RA studies, 97% of COPD patients treated with ORENCIA developed adverse reactions versus 88% treated with placebo and 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 adult RA 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 RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in RA 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 JIA and adult PsA patients were similar in frequency and type to those seen in adult RA 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:

Ruperto N, Lovell DJ, Quartier P, et al; Paediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008;372(9636):383-391.

Ruperto N, Lovell DJ, Quartier P, et al; Paediatric Rheumatology International Trials Organization and the Pediatric Rheumatology Collaborative Study Group. Long-term safety and efficacy of abatacept in children with juvenile idiopathic arthritis. Arthritis Rheum. 2010;62(6):1792-1802.

ORENCIA (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb.

Lovell DJ, Ruperto N, Mouy R, et al; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Long-term safety, efficacy, and quality of life in patients with juvenile idiopathic arthritis treated with intravenous abatacept for up to seven years. Arthritis Rheumatol. 2015;67(10):2759-2770.

Data on file ABAT 148. Princeton, NJ; Bristol-Myers Squibb.

Data on file ABAT 147. Princeton, NJ; Bristol-Myers Squibb.

References:

Mease PJ, Gottlieb AB, van der Heijde D, et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017. doi: 10.1136/annrheumdis-2016-210724.

Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74:423-441.

Mease P, Genovese MC, Gladstein G, et al. Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis Rheum. 2011;63:939-948.

Mease P, Goffe BS. Diagnosis and treatment of psoriatic arthritis. J Am Acad Dermatol. 2005;52:1-19.

References:

ORENCIA® Princeton, NJ: Bristol-Myers Squibb.

Mease PJ, Gottlieb AB, van der Heijde D, et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017. doi: 10.1136/annrheumdis-2016-210724.

References:

ORENCIA® Princeton, NJ: Bristol-Myers Squibb.

Mease PJ, Gottlieb AB, van der Heijde D, et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017. doi: 10.1136/annrheumdis-2016-210724.

References:

ORENCIA® Princeton, NJ: Bristol-Myers Squibb.

Schiff M, Koo J, Jin E, et al. Usability and acceptability of abatacept pre-filled autoinjector for the subcutaneous treatment of rheumatoid arthritis. Adv Ther. 2016;33(2):199-213.