Deucravacitinib superior to placebo for ACR20 response in psoriatic arthritis
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Deucravacitinib, a TYK2 inhibitor, was well-tolerated and superior to placebo in improving ACR20 response among patients with psoriatic arthritis, according to data published in the Annals of the Rheumatic Diseases.
“A substantial proportion of patients with PsA are inadequately treated with currently available therapeutic options; many of these medications have safety concerns and have inconvenient dosing, and few patients reach treatment targets, such as achievement of minimal disease activity (MDA),” Philip J. Mease, MD, of the Swedish Medical Center, in Seattle, and colleagues wrote.
“Therapies with new modes of action that are safe, effective and have convenient dosing are needed to control the spectrum of disease manifestations and improve the quality of life of patients with PsA as another option for treatment, including in those who do not respond to other modalities,” they added. “... Deucravacitinib is a novel oral selective TYK2 inhibitor with a unique mechanism of action distinct from that of inhibitors of JAK 1/2/3.”
To examine the safety and efficacy of deucravacitinib (Bristol Myers Squibb) in patients with active PsA, Mease and colleagues conducted a randomized, multicenter, double-blind phase 2 trial across various sites throughout the Czech Republic, Hungary, Germany, Poland, Spain, Russia and the United States. Participants were required to have a diagnosis of PsA for at least 6 months, and to have fulfilled psA classification criteria at screening. Additionally, eligible patients had active joint disease, high-sensitivity C-reactive protein and one or more plaque psoriasis lesions measuring at least 2 cm.
A total of 203 participants with PsA were randomized 1:1:1 to receive either placebo, deucravacitinib 6 mg or deucravacitinib 12 mg once daily. The primary endpoint was ACR20 response at week 16. Secondary endpoints included improvement from baseline in physical function, as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and improvement of psoriatic skin lesions, as measured by the Psoriasis Area and Severity Index 75 response in patients with 3% or more body surface involvement at baseline.
According to the researchers, ACR20 responses were significantly higher in the deucravacitinib 6 mg and 12 mg groups, at 52.9% (OR = 2.4; 95% CI, 1.2-4.8) and 62.7% (OR = 3.6; 95% CI, 1.8-7.4), respectively, compared with 31.8% among those treated with placebo, at week 16.
Adverse events were reported more often in the deucravacitinib groups — at 65.7% — than in the placebo group — at 42.4%. Events reported most often among patients in the deucravacitinib groups included nasopharyngitis, sinusitis, bronchitis, rash, diarrhea and headache. Most events were rated as mild or moderate in terms of severity, according to the researchers.
“Selective inhibition of TYK2 with deucravacitinib is a promising therapeutic option for PsA,” Mease and colleagues wrote. “Deucravacitinib showed efficacy across multiple disease domains and patient-reported outcomes and has a safety profile that is consistent with its mechanism of action and with that observed in previous phase 2 and phase 2 trials in [psoriasis].”
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