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Pooled Safety

AMPLE 2-Year

ASSURE

NORD-STAR

Pooled Safety

AMPLE 2-Year

ASSURE

NORD-STAR

In a broad population with moderate to severe RA

ORENCIA demonstrated a proven safety profile1-14

13 clinical trials for more than 6700 patients 13 clinical trials for more than 6700 patients

Of these 13 trials, 7 are included in the clinical trials section of the Full Prescribing Information (103-002, 101-100, AIM, ATTAIN, ASSURE, AGREE, and ACQUIRE).

Pooled safety results1

Based on treatment of 2944 patients (1955 patients treated with ORENCIA IV, 989 with placebo) across 6 double-blind, placebo-controlled studies of 6 months or 1 year (103-002, 101-100, AIM, ATTAIN, ASSURE, AGREE). A subset of these patients received concomitant biologic DMARD therapy, such as a TNF antagonist (204 patients with ORENCIA, 134 with placebo). The concomitant use of ORENCIA with a TNF antagonist is not recommended.

Most common adverse reactions1

Adverse reactions occurring in 3% or more of patients and at least 1% more frequently in patients treated with ORENCIA IV during placebo-controlled RA studies are shown in the chart.

Pooled safety table of most common adverse reactions among 1955 ORENCIA patients and 989 placebo patients. Pooled safety table of most common adverse reactions among 1955 ORENCIA patients and 989 placebo patients.

*Includes 204 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).1

†Includes 134 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).1

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No Boxed Warning

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No new safety signals identified
in supporting studies8,10,12-14‡

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No lab monitoring required

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No contraindications1

Warnings and precautions1

Concomitant use with a TNF antagonist can increase the risk of infections and serious infections. Hypersensitivity and anaphylaxis have occurred. Serious infections have been reported. Screen for latent TB infection and viral hepatitis prior to initiating therapy. Update vaccinations prior to initiating ORENCIA. COPD patients may develop more frequent respiratory adverse reactions.

Most serious adverse reactions1

The most serious adverse reactions associated with ORENCIA therapy were serious infections and malignancies. In patients taking ORENCIA IV (n=1955),§ the rate of serious infections was 3.0% and the rate of malignancies was 1.3%. In patients taking placebo (n=989),¶ the rate of serious infections was 1.9% and the rate of malignancies was 1.1%.

Adverse reactions most frequently resulting in clinical intervention1

The adverse reactions most frequently resulting in clinical intervention (interruption or discontinuation of ORENCIA) were due to infection. The most frequently reported infections resulting in dose interruption were upper respiratory tract infection (1%), bronchitis (0.7%), and herpes zoster (0.7%). The most frequent infections resulting in discontinuation were pneumonia (0.2%), localized infection (0.2%), and bronchitis (0.1%).

Infections1

In placebo-controlled trials, infections were reported in 54% of ORENCIA-treated patients and 48% of placebo-treated patients. The most commonly reported infections (5%-13% of patients) were upper respiratory tract infection, nasopharyngitis, sinusitis, urinary tract infection, influenza, and bronchitis.

  • The safety experience of ORENCIA SC was consistent with that of ORENCIA IV

COPD, chronic obstructive pulmonary disease; DMARD, disease-modifying antirheumatic drug; IV, intravenous; RA, rheumatoid arthritis; SC, subcutaneous; TB, tuberculosis; TNF, tumor necrosis factor.

‡Post-approval double-blind, randomized studies that enrolled 1651 patients and evaluated the efficacy and safety of ORENCIA include AMPLE, ACCOMPANY, ATTUNE, AVERT, and ATTEST. The primary endpoints of ATTEST and ACCOMPANY were related specifically to evaluation of the safety and/or immunogenicity of ORENCIA for use in moderate-to-severe RA.8,10,12-14

§Includes 204 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).1

Includes 134 patients on concomitant biologic DMARDs (adalimumab, anakinra, etanercept, or infliximab).1

AMPLE 2-YEAR

ORENCIA SC + MTX vs adalimumab SC + MTX in a broad population of MTX-IR patients with moderate to severe RA

Safety summary at 2 years14

The AMPLE 2-Year Trial was a randomized, Phase IIIb, head-to-head noninferiority trial of adult MTX-IR patients, and is not contained within the Full Prescribing Information. It is a supportive trial to AGREE, which was studied in MTX-naïve patients and had a different comparator. Patients were randomized to ORENCIA SC + MTX (n=318) or adalimumab SC + MTX (n=328).7,14

Over half of patients had
≥1 comorbid condition15

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At 2 years, SAEs occurred in 13.8% of
ORENCIA patients and 16.5% of
patients taking adalimumab14

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Discontinuations due to AEs occurred
in 3.8% of ORENCIA patients and
9.5% of adalimumab patients. These
AEs included opportunistic infections,
serious infections, and autoimmune
events14*

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No patients discontinued due to
injection-site reactions in the ORENCIA
group and 3 patients discontinued in
the adalimumab group14

Safety summary of 318 ORENCIA and 328 adalimumab patients at 2 years. Safety summary of 318 ORENCIA and 328 adalimumab patients at 2 years.

Over half of patients had
≥1 comorbid condition15

*AEs causing discontinuation included opportunistic infections (0 in the ORENCIA arm and 2 in the adalimumab arm, both due to TB). In addition, 9 adalimumab patients discontinued for the category of "serious infections." Autoimmune events led to discontinuation in 2 cases of plaque psoriasis in the ORENCIA arm and one anti-dsDNA seroconversion in the adalimumab arm.14

†Most common local injection-site reactions reported were erythema, pruritus, pain, hematoma, reaction, and rash.14

‡There was one death in each of these arms; patients each experienced a cardiovascular event.14

dsDNA, double-stranded deoxyribonucleic acid; MTX, methotrexate; MTX-IR, inadequate response to methotrexate.

See the efficacy from AMPLE:
head-to-head
study of ORENCIA vs adalimumab

Some of the observed safety rates for ORENCIA and adalimumab in AMPLE 2-year data may differ from those previously reported; please refer to the Full Prescribing Information for each product.

Study Design14

Study Design14

646 patients were randomized into the ORENCIA SC + MTX arm with 318 patients taking 125 milligrams per week or the adalimumab SC + MTX arm with 328 patients taking 40 milligrams bi-weekly. 646 patients were randomized into the ORENCIA SC + MTX arm with 318 patients taking 125 milligrams per week or the adalimumab SC + MTX arm with 328 patients taking 40 milligrams bi-weekly.
  • 86.2% of patients using ORENCIA and 82% of those using adalimumab completed Year 1 of the study
  • 79.2% of patients using ORENCIA and 74.7% of those using adalimumab completed the study at Year 2

Primary Endpoint14

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

Selected Secondary Endpoint14

Proportion achieving remission* (DAS28-CRP <2.6)

  • 86.2% of patients using ORENCIA and 82% of those using adalimumab completed Year 1 of the study
  • 79.2% of patients using ORENCIA and 74.7% of those using adalimumab completed the study at Year 2

*Remission is defined as DAS28-CRP <2.6.16 Clinical remission does not mean drug-free remission or complete absence of disease activity.

Key Limitations of the Study14

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 regard to each patient’s treatment.

Key Inclusion Criteria14,16

  • ≥18 years of age with moderate to severe active RA with a confirmed diagnosis for ≤5 years
  • Inadequate response to MTX and biologic naïve
  • ≥3.2 DAS28-CRP and a history of ≥1 of the following:
    • Seropositivity for anti-CCP or RF
    • Elevated ESR or CRP level

Key Exclusion Criteria17

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

Baseline Characteristics14,15

  • Average age: 51.4 for ORENCIA-treated patients, 51 years for adalimumab-treated patients
  • Study reports did not always include detailed patient characteristic data for all individual patients. In patients for whom detailed characteristic data were available:
    • ORENCIA group (n=310): 62% had at least one comorbid condition, the most frequent being high blood pressure (42%) and high cholesterol (26%)
    • Adalimumab group: 315 patients had detailed patient characteristic data. 55% had at least one comorbid condition, the most frequent being high blood pressure (38%) and high cholesterol (26%)

The AMPLE 2-Year Trial (not included in the Full Prescribing Information) is supportive clinical trial to AGREE, a registrational trial in MTX-naïve patients with a different comparator.7,14

ACR, American College of Rheumatology; anti-CCP, anti-cyclic citrullinated peptide; CRP, C-reactive protein; DAS28, Disease Activity Score in 28 joints; ESR, erythrocyte sedimentation rate; RF, rheumatoid factor.

ASSURE

In MTX-IR/bDMARD-IR patients with moderate to severe RA

Incidence of AEs and SAEs with ORENCIA were similar to placebo6*

ASSURE was a 1-year, multinational, multicenter, randomized, double-blind trial of 1231 patients who had previously received a biologic and/or nonbiologic DMARD that assessed the safety of ORENCIA IV 10 mg/kg + DMARD (n=836) vs placebo + DMARD (n=395).† Patients with stable comorbid conditions including diabetes (6%-7%), asthma (6%), COPD (4%), and congestive heart failure (1%-2%) were included in the trial.

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Infection rates were similar in the
ORENCIA arm vs placebo6

Summary of adverse events, serious adverse events,
and serious infections (nonbiologic background therapy)6

25% had a comorbid condition6‡

Summary of adverse events, serious adverse events, and serious infections (nonbiologic background therapy)6

Summary of adverse events for 856 ORENCIA and 418 placebo patients both taking disease- modifying antirheumatic drugs. Summary of adverse events for 856 ORENCIA and 418 placebo patients both taking disease- modifying antirheumatic drugs.

bDMARD-IR, inadequate response to biologic disease-modifying antirheumatic drug; CHF, congestive heart failure.

*ASSURE was powered to detect AEs occurring at a rate of 0.2%. No formal tests were planned to compare AE incidence rates between treatment groups.6

†All patients continued background RA therapies (biologic DMARDs, nonbiologic DMARDs, or a combination of both) at study entry, including: MTX, hydroxychloroquine, leflunomide, gold, azathioprine, anakinra, etanercept, infliximab, and adalimumab. Stable, low-dose oral corticosteroids (10 mg/day or less) were allowed.6

‡The number of patients with CHF or asthma was too small to permit conclusions to be drawn.6

AEs in COPD Patients1,6

Among patients with COPD, adverse events were frequent among both those receiving ORENCIA and 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. Most AEs were of mild-to-moderate intensity.

bDMARD-IR, inadequate response to biologic disease-modifying antirheumatic drug; CHF, congestive heart failure.

*ASSURE was powered to detect AEs occurring at a rate of 0.2%. No formal tests were planned to compare AE incidence rates between treatment groups.6

†All patients continued background RA therapies (biologic DMARDs, nonbiologic DMARDs, or a combination of both) at study entry, including: MTX, hydroxychloroquine, leflunomide, gold, azathioprine, anakinra, etanercept, infliximab, and adalimumab. Stable, low-dose oral corticosteroids (10 mg/day or less) were allowed.6

‡The number of patients with CHF or asthma was too small to permit conclusions to be drawn.6

AEs in COPD Patients1,6

Among patients with COPD, adverse events were frequent among both those receiving ORENCIA and 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. Most AEs were of mild-to-moderate intensity.

ASSURE: Study Design

Inclusion Criteria6

  • ≥18 years of age
  • Met ACR criteria for active RA
  • Active disease despite receiving ≥1 biologic and/or nonbiologic for RA for ≥3 months prior to enrollment
  • Patient’s global assessment of disease activity by VAS measurements was ≥20 mm

Exclusion Criteria6

  • Pregnant or nursing women
  • Active or chronic bacterial infections
  • Active herpes zoster, hepatitis B or C infections
  • Active or latent TB
  • Unstable or uncontrolled conditions such as: cardiovascular, pulmonary, renal, endocrine, hepatic, hematologic, gastrointestinal, or neurologic diseases

VAS, visual analog scale.

Learn more about ORENCIA access and support
NORD-STAR

In moderate-to-severe, treatment-naïve, early RA patients with poor prognostic factors

Safety results in 3 biologics and active conventional therapy (ACT)18

NORD-STAR (N=795) was a 48-week, multicenter, randomized, blinded-assessor study in patients with early rheumatoid arthritis and seropositivity (RF+ or anti-CCP+) or CRP ≥10 mg/L and DAS28-CRP >3.2.

Safety results among 197 patients taking active conventional therapy, 202 patients taking certolizumab pegol, 204 patients taking ORENCIA, and 184 patients taking tocilizumab. Safety results among 197 patients taking active conventional therapy, 202 patients taking certolizumab pegol, 204 patients taking ORENCIA, and 184 patients taking tocilizumab.

Trial was designed to compare ACT to each biologic option. Comparisons cannot be drawn between ORENCIA and other biologics.

ORENCIA was studied in treatment-naïve, early RA patients with poor prognostic factors18

Patients were randomized into 4 treatment arms

  1. Active Conventional Therapy: prednisolone or triple therapy (MTX + csDMARDs) + glucocorticoids (n=200)*
  2. CTX: certolizumab pegol SC 200 mg (400 mg at 0, 2, 4 weeks) (n=203)
  3. ORENCIA SC 125 mg (n=204)
  4. TCL: tocilizumab IV 8 mg/kg/4 weeks or SC 162 mg/weekly (n=188)†

All patients received MTX starting on Day 1 (escalated to 25 mg/week within 4 weeks). MTX dose could be reduced in all treatment arms due to toxicity/intolerability, and subsequently re-escalated up to 20 mg/week.18

Key Inclusion Criteria18

  • 18 years or older
  • Symptom duration of <24 months
  • Poor prognostic factors:
    • Moderate-to-severe disease activity with DAS28-CRP >3.2
    • ≥2 (of 66) swollen ≥2 (of 68) tender joints
    • RF+ or anti-CCP+ or CRP of ≥10 mg/L
  • Patient’s global assessment of disease activity by VAS measurements was ≥20 mm

Key Exclusion Criteria18

  • Previous treatment with a DMARD
  • Women nursing or pregnant
  • Inflammatory diseases other than RA

Limitations18

  • The ACT arm comprised 2 different treatment strategies based on national recommendations for conventional RA therapy in the individual countries
  • Analyses were adjusted for country effects, whereas the study was not powered for subgroup analyses
  • The open-label design may influence certain subjective outcomes

*Oral prednisolone (tapered from 20 mg/day to 5 mg/day in 9 weeks and discontinuation after 9 months) or enterotablets sulfasalazine (2 g/day), hydroxychloroquine (35 mg/kg/week or 200 mg/day) and intra-articular triamcinolone hexacetonide injection (or equivalent) in all swollen joints at each visit (maximally 4 joints and 80 mg/visit).18

†17 Finnish patients randomized to arm 4 (tocilizumab + MTX) but not receiving it due to unavailability are not included. They were excluded from the ITT population to allow a fair analysis of the efficacy of tocilizumab. Robustness analyses showed comparable results.18

See NORD-STAR efficacy

Important Safety Information
for ORENCIA® (abatacept)

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

Hypersensitivity Reactions: 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. ORENCIA-treated patients may receive current non-live vaccines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations. In addition, it is unknown if the immune response of an infant who was exposed in utero to abatacept and subsequently administered a live vaccine is impacted. Risks and benefits should be considered prior to vaccinating such infants.

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

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

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

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

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

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

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

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

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

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

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

Please click here for Full Prescribing Information

References: 1. ORENCIA® [package insert]. Princeton, NJ: Bristol Myers Squibb.  2. Moreland LW, Alten R, Van den Bosch F, et al. Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion. Arthritis Rheum. 2002;46(6):1470-1479. doi:10.1002/art.10294.  3. Kremer JA, 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. doi:10.1056/NEJMoa035075.  4. Kremer JM, Peterfy C, Russell AS, et al. Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial. J Rheumatol. 2014;41(6):1077-1087. doi:10.3899/jrheum.130263.  5. Data on File. ABAT 166. Princeton, NJ: Bristol Myers Squibb.  6. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition [published correction appears in N Engl J Med. 2005 Nov 24;353(21):2311]. N Engl J Med. 2005;353(11):1114-1123. doi:10.1056/NEJMoa050524.  7. Westhovens R, Robles M, Ximenes AC, et al. Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis. 2009;68(12):1870-1877. doi:10.1136/ard.2008.101121.  8. Schiff M, Keiserman M, Codding C, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008;67(8):1096-1103. doi:10.1136/ard.2007.080002.  9. Genovese MC, Covarrubias A, Leon G, et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011;63(10):2854-2864. doi:10.1002/art.30463.  10. Nash P, Nayiager S, Genovese MC, et al. Immunogenicity, safety, and efficacy of abatacept administered subcutaneously with or without background methotrexate in patients with rheumatoid arthritis: results from a phase III, international, multicenter, parallel-arm, open-label study. Arthritis Care Res (Hoboken). 2013;65(5):718-728. doi:10.1002/acr.21876. 11. Kaine J, Gladstein G, Strusberg I, et al. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase IIIb ALLOW study). Ann Rheum Dis. 2012;71(1):38-44. doi:10.1136/annrheumdis-2011-200344. 12. Keystone EC, Kremer JM, Russell A, et al. Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study. Ann Rheum Dis. 2012;71(6):857-861. doi:10.1136/annrheumdis-2011-200355.  13. Emery P, Burmester GR, Bykerk VP, et al. Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period. Ann Rheum Dis. 2015;74(1):19-26. doi:10.1136/annrheumdis-2014-206106. 14. 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. doi:10.1136/annrheumdis-2013-203843.  15. Data on File. REF-01226-427. Princeton, NJ: Bristol Myers Squibb.  16. 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. doi:10.1002/art.37711.  17. Data on File. ABAT 143. Princeton, NJ: Bristol Myers Squibb.  18. Østergaard M, van Vollenhoven RF, Rudin A, et al; NORD-STAR study group. Certolizumab pegol, abatacept, tocilizumab or active conventional treatment in early rheumatoid arthritis: 48-week clinical and radiographic results of the investigator-initiated randomised controlled NORD-STAR trial. Ann Rheum Dis. 2023;82:1286-1295. doi:10.1136/ard-2023-224116.