Adalimumab Safe and Effective for Non-Psoriatic SpA

Mease P, Sieper J,Van den Bosch F, et al., Randomized Controlled Trial of Adalimumab in Patients With Nonpsoriatic Peripheral Spondyloarthritis. Arthritis & Rheumatology. 2015; 67:914–923. doi:10.1002/art.39008

An ongoing phase III clinical trial shows that adalimumab (Humira) relieves symptoms and improves physical function in patients with active non-psoriatic peripheral spondyloarthritis (SpA) unable to take non-steroidal anti-inflammatory drugs (NSAIDs).

After a 12-week double-blind period, almost twice as many of the adalimumab-treated patients showed a 40% improvement in at least one area of disease activity-including pain and swollen/tender joints-as those on placebo, according to the industry-sponsored study.

The safety profile is consistent with that seen in patients with anklyosing spondylitis, PsA, or other immune-mediated diseases, with similar rates of adverse events in the adalimumab and placebo groups, investigators add.

ABILITY-2 is the first multicenter, global study of adalimumab among patients who meet the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for peripheral SpA.

The 165 study patients, half of them women, do not have a prior diagnosis of psoriasis, psoriatic arthritis (PsA), nor ankylosing spondylitis (AS), and have either a contraindication or intolerance to NSAIDs, or show an inadequate response to at least two of the drugs.

The patients were randomized to either 40 mg adalimumab every other week (n=84) or placebo (n=81) for 12 weeks, followed by a 144-week open-label period.

At three months, 39% showed a 40% improvement in disease activity according to the Peripheral SpA Response Criteria (PSpARC40), compared to 20% among the placebo group. A significantly greater proportion also achieved remission.

A PSpARC40 response is defined as a 40% or greater improvement from baseline (20-mm or greater absolute improvement on a visual analog scale, VAS) in patient’s global assessments of disease activity and pain, as well as swollen and tender joint counts, total enthesitis count, or dactylitis count.

The study is sponsored by AbbVie, several of the investigators report financial support from the company, and two own stock.

The current trial results come as an adalimumab biosimilar is being tested in rheumatoid arthritis (RA) patients.