Janssen gets two US FDA approvals for Simponi Aria to treat active psoriatic arthritis

Today’s approvals follow the first FDA approval of SIMPONI ARIA in 2013 for the treatment of moderately to severely active rheumatoid arthritis (RA). The PsA and AS approvals are supported by comprehensive clinical development programs that demonstrated the significant efficacy of SIMPONI ARIA over placebo, while offering a consistent safety profile across all indications.

 In the study for the treatment of active PsA, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study for treatment of active AS, results showed improvement in measures of disease activity.

“There is a need for new treatment options for patients with psoriatic arthritis. The results of the Phase 3 study of intravenous (IV) golimumab in patients with psoriatic arthritis demonstrated significant and clinically important efficacy across various domains including the inhibition of structural damage,” said Arthur Kavanaugh, M.D., Professor of Medicine, University of California San Diego, and Chair of the GO-VIBRANT steering committee.

“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.”

The approvals of SIMPONI ARIA for PsA and AS are based on two large-scale, pivotal Phase 3 studies involving more than 600 patients. In both studies, the primary endpoints were met, with a higher proportion of patients demonstrating significant improvement in the signs and symptoms of PsA and AS in the groups receiving treatment with SIMPONI ARIA compared with those receiving placebo.

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.

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.

“Ankylosing spondylitis is a disease that adversely affects quality of life and the choices for treating this disabling condition are limited; The approval of IV golimumab for the treatment of active ankylosing spondylitis provides a welcomed new option,” said Atul Deodhar, M.D., Professor of Medicine at the Oregon Health & Science University in Portland, and Chair of the GO-ALIVE steering committee.

 “The GO-ALIVE Phase 3 study demonstrated the efficacy of IV golimumab in reducing the signs and symptoms of disease, as well as improving physical function and quality of life in patients.”

“Over the past 20+ years, Janssen has been pioneers in addressing the unmet needs of patients living with rheumatologic diseases like psoriatic arthritis and ankylosing spondylitis,” said Andrew Greenspan, M.D., Vice President of Medical Affairs at Janssen Scientific Affairs, LLC.

“SIMPONI ARIA has been helping patients with rheumatoid arthritis since its approval in 2013. With today’s FDA approvals, we are pleased to extend the benefits of SIMPONI ARIA to adult patients living with active psoriatic arthritis or active ankylosing spondylitis. We know having all three indications is valuable to rheumatologists and for patients who prefer to have their treatment administered by their healthcare provider.”

Janssen will work with payers, providers and pharmacy benefit managers to ensure SIMPONI ARIA is broadly accessible for patients and that the cost for payers is competitive with currently available biologic therapies for PsA and AS.

The Janssen CarePath Savings Program offers an affordability option for SIMPONI ARIA, where eligible commercial patients pay just $5 for each infusion for SIMPONI ARIA medication costs.

The Phase 3, multicenter, randomized, double-blind, placebo-controlled GO-VIBRANT study was 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.

The Phase 3, multicenter, randomized, double-blind, placebo-controlled GO-ALIVE study was 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.