Bristol-Myers Squibb’s ORENCIA® (abatacept) Receives Second European Commission Approval in Less than a Year – New Approval for Treatment of Active Psoriatic Arthritis (PsA)1
- Category: Antibodies
- Published on Wednesday, 26 July 2017 18:43
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Patients demonstrated improved disease response in two clinical trials that included both TNF-naïve and challenging to treat TNF-exposed patients with active musculoskeletal involvement 1
PRINCETON, NJ, USA I July 26, 2017 I Bristol-Myers Squibb Company (NYSE: BMY) announced today that the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active Psoriatic Arthritis (PsA) in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.1
This approval, which allows for the expanded marketing of ORENCIA as a treatment for PsA in all 28 Member States of the EU, marks the second new indication for ORENCIA in less than a year; in September 2016, the European Commission approved ORENCIA, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. PsA becomes the third autoimmune condition, along with rheumatoid arthritis and juvenile idiopathic arthritis, for which ORENCIA is approved to treat in Europe.1
“This EC approval builds on the well-established profile of ORENCIA in Rheumatoid Arthritis and exemplifies our commitment to ongoing clinical research of ORENCIA as a potential treatment for autoimmune conditions where treatment options are limited or where patients have not been helped enough by other medications,” said Brian J. Gavin, Ph.D., Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “Despite the current availability of medications, there are many people with active Psoriatic Arthritis who are in need of a new treatment option; the approval of ORENCIA now provides a novel immunotherapy approach that may help these patients.”
The approval was based on results from two randomized, double-blind, placebo-controlled studies (Studies PSA-I and PSA-II) in which a higher proportion of patients achieved an ACR 20 response, the primary endpoint, after treatment with ORENCIA 10 mg/kg intravenous (IV) or 125 mg subcutaneous injection (SC) compared to placebo at Week 24: 47.5% versus 19.0% and 39.4% versus 22.3% (p< 0.05), respectively.1 Responses were seen regardless of prior tumor necrosis factor inhibitor (TNFi) treatment in both studies.1
In the phase 3 study, PsA-II, the proportion of radiographic non-progressors (≤0 change from baseline) in total PsA-modified SHS on x-rays at Week 24 was greater with ORENCIA 125 mg SC (42.7%) than placebo (32.7% (10.0 [1.0, 19.1] estimate of difference [95% CI]).1 There were no adverse reactions that occurred at ≥ 2% in either treatment group during the 24-week placebo-controlled period. The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis.1 Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events occurring at a rate of ≥ 10% in patients taking ORENCIA in the adult RA clinical studies.1
In PsA, the immune system attacks healthy joints and skin.3 T-cell activation is involved in the pathogenesis of PsA.4 The costimulation blockade of ORENCIA inhibits T-cell activation and the resulting cascade of events that contribute to joint destruction. Both IV and SC injection formulations of ORENCIA are now approved to treat adult patients with active PsA.
Additional Information About Studies PSA-I and PSA-II
The efficacy of ORENCIA was assessed in two randomized, double-blind, placebo-controlled studies (Studies PsA-I and PsA-II) in 594 adult patients,1 with a disease duration more than 7 years.4,5 Patients had active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.1 In PsA-I and PsA-II, 37% and 61% of patients, respectively, were treated with TNFi previously.1 The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (Day 169).1
In PsA-I, 170 patients received placebo or ORENCIA IV at Days 1, 15, 29, and then every 28 days thereafter in a double blind manner for 24 weeks, followed by open-label ORENCIA 10 mg/kg IV every 28 days.1 Patients were randomized to receive placebo or ORENCIA 3 mg/kg, 10 mg/kg (weight range-based dosing: 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1000 mg for patients weighing greater than 100 kg), or two doses of 30 mg/kg followed by weight range-based dosing of 10 mg/kg without escape for 24 weeks, followed by open label ORENCIA 10 mg/kg monthly IV every month.1 Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At enrollment, approximately 60% of patients were receiving methotrexate.1
In PsA-II, also known as ASTRAEA, 424 patients were randomized 1:1 to receive weekly doses of SC placebo or ORENCIA 125 mg without a loading dose for 24 weeks, followed by open-label ORENCIA 125 mg SC weekly.1 Patients were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial. At randomization, 60.4% of patients were receiving methotrexate.1
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic6, inflammatory disease that can affect both the skin and musculoskeletal system.2 PsA can cause joint pain, stiffness and reduced range of motion, and can eventually lead to irreparable joint damage.2 Most commonly affecting the distal joints (those closest to the nail) of the fingers or toes, as well as the wrists, knees, ankles and lower back, the disease usually appears between the ages of 30 to 50, but can begin as early as childhood.2 Men and women are equally at risk.2 Early recognition, diagnosis and treatment of Psoriatic Arthritis are critical to relieve pain and inflammation and help prevent joint damage.2
U.S. Indications/Usage and Important Safety Information for ORENCIA® (abatacept)
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.
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).
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.
About Bristol-Myers Squibb Immunoscience
With a robust pipeline of immunomodulatory therapies, Bristol-Myers Squibb is committed to the discovery and development of transformational medicines for patients suffering from immune-mediated disease. As we learn more about the immune system in diseases with substantial unmet medical needs, the potential for new therapies that modulate the immune system continues to drive our research efforts.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.
1. ORENCIA® Annex I: Summary of Product Characteristics. Bristol-Myers Squibb Company, Princeton, NJ. June 2017.
2. Psoriatic Arthritis Overview. National Institutes of Health. https://www.niams.nih.gov/Health_info/Psoriatic_Arthritis/default.asp. Accessed May 8, 2017.
3. What is Psoriatic Arthritis? The Arthritis Foundation. http://www.arthritis.org/about-arthritis/types/psoriatic-arthritis/what-is-psoriatic-arthritis.php. Accessed May 8, 2017.
4. Mease P., Gottlieb A., Heijde H., et al. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase 3 study in psoriatic arthritis. Annals of the Rheumatic Diseases. 2017
5. Mease P, Genovese MC, Gladstein G. Abatacept in the treatment of patients with psoriatic arthritis: Results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial. Arthritis & Rheumatism. 2011;63(4):939-948.
6. Psoriatic Arthritis. American College of Rheumatology. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed May 8, 2017.
SOURCE: Bristol-Myers Squibb