medwireNews: Results of two phase II trials published in Arthritis & Rheumatology suggest that ABT-122, an antibody targeting tumor necrosis factor (TNF) and interleukin(IL)-17A, has a similar efficacy and safety profile to that of adalimumab in patients with rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
In the first study, methotrexate-treated patients with active RA and no prior exposure to biologic therapy were randomly assigned to receive 12 weeks of treatment with subcutaneous ABT-122 at a dose of 60 mg every 2 weeks, 120 mg every 2 weeks, or 120 mg every week, or to receive the TNF inhibitor adalimumab 40 mg every 2 weeks.
Mark Genovese (Stanford University Medical Center, Palo Alto, California, USA) and study co-authors report that the overall incidence of treatment-emergent adverse events (TEAEs) “was similar among all of the treatment groups,” with between 36.4% and 41.8% of patients in the ABT-122 groups and 42.9% of those in the adalimumab group experiencing TEAEs over the 12-week study period. No serious infections or hypersensitivity reactions occurred.
A comparable proportion of patients in the four groups achieved at least a 20% improvement in ACR criteria (ACR20) at the 12-week follow-up, with rates of 61.8% for the 55 patients given ABT-122 at a dose of 60 mg, 75.0% for the 56 given 120 mg every 2 weeks, 80.0% for the 55 patients given 120 mg every week, and 67.9% for the 56 patients in the adalimumab group.
Although the ACR20 response rate was numerically higher for participants given the 120 mg dose of ABT-122, differences between the groups did not reach statistical significance.
In accordance with these results, the authors of the second study found similar ACR20 response rates among ABT-122- and adalimumab-treated patients with PsA and an inadequate response to methotrexate.
Specifically, 64.8% of 71 patients given ABT-122 at 120 mg every week and 75.3% of 73 patients given the drug at a dose of 240 mg every week achieved an ACR20 response after 12 weeks of treatment. These rates were significantly higher than the 25.0% rate for the 24 patients treated with placebo, but comparable to that for the 72 patients given adalimumab 40 mg every 2 weeks, at 68.1%.
Philip Mease (Swedish Medical Center and University of Washington, Seattle, USA) and study co-authors note that a significantly higher proportion of patients treated with ABT-122 at a dose of 240 mg versus adalimumab achieved at least a 75% improvement in Psoriasis Area and Severity Index score at week 12 (78 vs 58%), but they say that ABT-122 “was generally similar to adalimumab” for the efficacy outcomes tested.
They found that the incidence of TEAEs was similar across all treatment groups, with no serious infections or hypersensitivity reactions reported.
“[T]he similarity of AE incidences with ABT-122 and adalimumab adds to a growing database suggesting that inhibition of two cytokines may not always be associated with higher AE incidences,” write Mease and colleagues.
However, in light of the findings from the two trials, the authors of both studies conclude that further development of ABT-122 “is not being pursued” for the treatment of RA and PsA.
medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group