Dual neutralization of tumor necrosis factor and interleukin-17A with ABT-122 demonstrated efficacy and safety similar to that of adalimumab over 12 weeks of treatment in people with psoriatic arthritis (PsA) who had an inadequate response to methotrexate. Results of the double-blind, parallel-group, randomized, placebo-controlled trial (ClinicalTrials.gov identifier: NCT02349451) were published in Arthritis & Rheumatology.
A total of 240 patients were randomly assigned to receive ABT-122 120 mg weekly, ABT-122 240 mg weekly, adalimumab 40 mg every other week, or placebo. The primary efficacy end point was ≥20% improvement in the American College of Rheumatology criteria (ACR20 response) at 12 weeks. Secondary and exploratory end points included ACR50, ACR70, and Psoriasis Area and Severity Index (PASI75 and PASI90 skin scores) in participants in whom ≥3% of body surface area was affected.
In the ABT-122 120-mg and 240-mg treatment groups, ACR20 responses at 12 weeks (64.8% to 75.3%) were significantly superior to those of the placebo group (25%; P <.001), but not of the adalimumab group (68.1%). ACR50 and ACR760 responses were also significantly superior in the ABT-122 120-mg and 240-mg groups (36.6%-53.4% and 22.5%-31.5%, respectively) vs placebo (12.5% and 4.2%; P< .05).
Among eligible patients, PASI75 was attained in 27.3%, 57.6%, 74.4%, and 77.6% of patients treated with placebo, adalimumab, ABT-122 120 mg, and ABT-122 240 mg, respectively, and PASI90 was achieved in 18.2%, 45.5%, 48.8%, and 46.9% of patients. No discontinuations were associated with treatment-emergent adverse events, which were similar across all treatment groups. There were no systemic hypersensitivity reactions or serious infections reported with ABT-122 therapy.
The investigators concluded that the similarity of adverse event incidences reported with ABT-122 and adalimumab suggests that inhibition of 2 cytokines may not always be associated with higher rates of adverse events. Because there was no clearly differentiated efficacy reported between the 2 agents, however, further development of ABT-122 for the treatment of PsA is not being pursued at the current time.
Please see the original article for a full list of disclosures.
Mease PJ, Genovese MC, Weinblatt ME, et al. Phase 2 study of ABT-122, a TNF- and IL-17A-targeted dual variable domain immunoglobulin, in psoriatic arthritis with inadequate methotrexate response [published online May 31, 2018]. Arthritis Rheumatol. doi: 10.1002/art.40579