Amgen Presents New Research In Early Psoriatic Arthritis At Acr 2023

Amgen today announced results from the global Phase 4 FOREMOST study evaluating Otezla® (apremilast) in patients with early oligoarticular psoriatic arthritis. FOREMOST is the first placebo-controlled study designed to specifically assess people with oligoarticular psoriatic arthritis with early disease duration of five or fewer years. Results will be presented at the American College of Rheumatology (ACR) Convergence 2023, Nov. 10-15 in San Diego.

"Patients with early oligoarticular psoriatic arthritis who received Otezla were twice as likely as patients receiving placebo to achieve MDA-Joints, a composite endpoint representing minimal disease activity at 16 weeks," said Philip Mease, M.D., MACR, director, Rheumatology Research, Providence Swedish Medical Center, clinical professor, University of Washington School of Medicine, Seattle, and FOREMOST presenting author at ACR. "These patients experienced a significant reduction in psoriatic disease activity, a crucial finding for those in the early stages of the condition."

"Psoriatic arthritis patients with a smaller number of affected joints have been underrepresented in clinical trials, even though oligoarticular psoriatic arthritis is very common and can cause patients significant pain and functional impairment," said Laure Gossec, M.D., Ph.D., professor of rheumatology, Sorbonne Université and Pitié Salpêtrière Hospital, Rheumatology, Paris. "FOREMOST found that people with oligoarticular disease experienced significant improvements with Otezla. This is a key trial, which will help clinicians and patients with this disease type to discuss treatment choices in a data-driven manner."

"Otezla has been studied in numerous trials and prescribed to 840,000 patients, yet we continue to identify unmet needs and opportunity to benefit patients," said Ponda Motsepe-Ditshego, vice president, Global Medical at Amgen. "This research builds on our ongoing goal to reduce the burden of psoriatic disease and improve outcomes for patients." 

The multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 4 FOREMOST study met the primary endpoint of modified minimal disease activity (MDA-Joints) and key secondary endpoints at week 16. In patients with early psoriatic arthritis disease duration (≤5 years) and ≤4 tender and ≤4 swollen joints affected, Otezla plus standard of care doubled the modified minimal disease activity (MDA-Joints) response compared to placebo plus standard of care. In the study, standard of care was defined as nonsteroidal anti-inflammatory drugs (NSAIDs), oral glucocorticosteroids or ≤1 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

Detailed study findings include: 

33.9% of patients treated with Otezla achieved MDA-Joints response versus 16.0% with placebo, (p=0.0008), the primary endpoint.

70.2% of patients treated with Otezla achieved Clinical Disease Activity in psoriatic arthritis (cDAPSA) remission (REM ≤4) or low disease activity (LDA >4 to ≤13) versus 51.8% with placebo, as measured by patient global assessment score (p=0.0017), the key secondary endpoint.

Common treatment-emergent adverse events (TEAEs) that occurred in more than 5% of Otezla patients were diarrhea (23.0%), nausea (10.8%) and headache (7.8%). TEAEs were consistent with the known safety profile of Otezla.

The study randomized 308 patients with a mean disease duration of 9.9 months, of whom 39.9% were using a csDMARD. MDA-Joints was a composite endpoint consisting of tender joint count ≤1 and swollen joint count ≤1 plus achieving 3 of the following: psoriasis Body Surface Area (BSA) ≤3%, patient assessment of pain visual analog scale (VAS) on a 100-mm scale ≤15, Patient Global Assessment (PtGA) of disease activity on a 100-mm scale ≤20, physical function [HAQ-DI] ≤0.5, and enthesitis count ≤1 based on the Leeds Enthesitis Index.

The FOREMOST oral presentation is one of more than 20 Amgen-sponsored abstracts at ACR highlighting new scientific and clinical research across its expanded rheumatology pipeline.

About Psoriatic Arthritis    

Psoriatic arthritis is a chronic, inflammatory form of arthritis, which can cause swelling, stiffness and pain in and around the joints that worsens over time and can decrease physical function. It is estimated that nearly 38 million people worldwide have psoriatic arthritis.1 Around a third of people living with psoriasis may go on to develop psoriatic arthritis.1 If left untreated, psoriatic arthritis can cause disability.

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