This article is more than 5 years old. Information may no longer be current.
Patients with non-psoriatic peripheral SpA show positive response to Humira
Compared with placebo, more than one-third of patients with non-psoriatic spondyloarthritis who had not responded to treatment with NSAIDs showed reduced disease activity, and many reported quality-of-life improvements while taking Humira, according to recently published research.
Patients with non-psoriatic, peripheral spondyloarthritis were enrolled in the ABILITY-2 study, an ongoing, randomized, placebo-controlled, double-blind, phase 3 trial throughout the U.S., Australia, Canada and Europe at 28 centers. Those ages 18 years and older were eligible in the presence of non-psoriatic spondyloarthritis (SpA) based on the Assessment of SpondyloArthritis International Society (ASAS) criteria and two or more swollen or tender joints, sites of enthesitis or digits showing dactylitis, as well as a minimum score of 40 mm on a VAS between 0 mm and 100 mm. Eligible participants also previously showed inadequate response to NSAIDs; however, concurrent use of disease-modifying anti-rheumatic drugs or NSAIDs was permitted during the trial.
The 165 eligible participants were randomly assigned to receive either 40 mg subcutaneous Humira (adalimumab, AbbVie) every other week or matching placebo for a total of 12 weeks, with the option to continue into a 144-week open-label trial with administration of adalimumab.
The primary endpoint of reduced disease activity, measured by a Peripheral SpA Response Criteria of 40% (PSpARC40) improvement, was met by 39% of the patients receiving adalimumab compared with 20% of patients taking placebo based on VAS scores.
Two patients from the treatment group discontinued the study after one developed whole-body dermatitis and the other withdrew consent. One patient developed scabies but completed the 12-week trial.
Statistical analysis showed patients with elevated high-sensitivity C-reactive protein (hsCRP) at baseline were more likely to meet PSpARC40 (51% of patients treated) compared with 16% of patients in the placebo group, according to the researchers.
Among patients with normal hsCRP levels, 31% met PSpARC40 in the adalimumab group compared with 23% of patients who received placebo. Patients in the treatment group were also more likely to achieve remission and have fewer swollen or tender joints, according to the researchers. -by Shirley Pulawski
Disclosure: Mease has received honoraria and/or speaking fees of more than $10,000 from AbbVie. Please see the full study for a list of all other authors’ relevant financial disclosures.
Collapse