FDA Approves Simponi Aria for Psoriatic Arthritis and Ankylosing Spondylitis Save

Janssen Biotech, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI ARIA® (golimumab) the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).

These approvals are based on the GO-VIBRANT (in PsA) and GO-ALIVE (in AS) clinical trials previously reported. Simponi Aria was also approved in 2013 for the treatment of moderately to severely active rheumatoid arthritis (RA).

Arthur Kavanaugh, MD, from the University of California San Diego, who headed up the GO-VIBRANT study, stated, “The approval of IV golimumab for the treatment of active psoriatic arthritis brings an important new treatment option to patients, especially those who prefer IV administration, and offers one with a 30-minute infusion time.” (Citation source: http://onlinelibrary.wiley.com/doi/10.1002/art.40226/full)

GO-VIBRANT was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Simponi Aria in biologic-naïve adult patients with active PsA. Patients (n=480) were randomized one-to-one to receive Simponi Aria 2 mg/kg at weeks 0 and 4, and then every 8 weeks thereafter or placebo at weeks 0, 4, 12 and 20 with crossover to Simponi Aria at week 24. Patients who were on stable doses of methotrexate (MTX) were allowed to enroll in the study and remained on MTX during the double-blind phase. The primary endpoint was ACR20 response at week 14. Multiplicity-controlled endpoints at week 14 or 24 included ACR50, ACR70, at least a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75) and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI), enthesitis, dactylitis, van der Heijde Sharps (vdH-S) and Short Form (SF)-36 Physical Component (PC)/Mental Component (MC) scores. The study continued through 60 weeks.

In the GO-VIBRANT (PsA) study, 75 percent of patients receiving Simponi Aria, compared with 22 percent of patients receiving placebo (P < 0.001), achieved at least a 20 percent improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with SIMPONI ARIA® resulted in the inhibition of the progression of structural joint damage and improvement in physical function associated with PsA at week 24. 

GO-ALIVE was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Simponi Aria in adult patients with active AS. Patients (n=208) were randomized one-to-one to receive Simponi Aria 2 mg/kg at weeks 0 and 4, and then every 8 weeks thereafter or placebo at weeks 0, 4 and 12, with crossover to Simponi Aria at week 16. The primary endpoint was ASAS20 response at week 16. Multiplicity-controlled endpoints at week 16 included ASAS40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50), Bath Ankylosing Spondylitis Functional Index (BASFI), ASAS partial remission, Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQoL), and SF-36 PC/MC scores. The study continued through 60 weeks.

In the GO-ALIVE (AS) study, 73 percent of patients receiving Simponi Aria, compared with 26 percent of patients receiving placebo (P < 0.001), achieved at least a 20 percent improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16. ACR20 and ASAS20 are standard measures used to assess clinical improvement in PsA and AS, respectively.