Deucravacitinib superior to placebo for achieving psoriatic arthritis MDA at 16 weeks
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Key takeaways:
- In patients with psoriatic arthritis, deucravacitinib was linked with greater mean reductions vs. placebo in all MDA components at 16 weeks.
- Responses were comparable between 6 mg and 12 mg daily doses.
Deucravacitinib is superior to placebo for improving response across all domains of minimal disease activity criteria in patients with psoriatic arthritis at 16 weeks, according to data published in Rheumatology.
“In a phase 2 trial in patients with active PsA, deucravacitinib was significantly more efficacious than placebo after 16 weeks of treatment, including demonstrating significant improvements in musculoskeletal manifestations, psoriasis, and overall physical/mental health, with around 24% of patients achieving minimal disease activity (MDA) by Week 16,” Arthur Kavanaugh, MD, of the University of California, San Diego, and colleagues wrote.
“MDA, a composite measure that assesses disease activity across seven domains of PsA, including peripheral arthritis, skin lesions of psoriasis, enthesitis, and certain patient reported outcomes (PRO) related to pain and functional status has been recommended as an appropriate treatment target for patients with PsA,” they added. “Achieving MDA has been associated with improved quality of life, and it has been shown to have long-term prognostic value with regard to outcomes such as physical functioning and radiographic disease progression.”
To examine the efficacy of deucravacitinib (Sotyktu, Bristol Myers Squibb) in achieving individual MDA domains in patients with PsA, Kavanaugh and colleagues conducted a post hoc analysis of that aforementioned phase 2 trial. In that trial, 203 patients with PsA were randomly assigned to receive daily doses of either deucravacitinib 6 mg (n = 70), deucravacitinib 12 mg (n = 67) or placebo (n = 66).
The researchers assessed the number of patients with PsA in each arm met overall MDA criteria through 16 weeks. They additionally assessed all seven individual components of MDA, including tender joint count, swollen joint count and Patient Global Assessment of Pain.
Compared with placebo, patients who received deucravacitinib demonstrated numerically greater average reductions in all individual MDA components at 16 weeks, according to the researchers. Between the two deucravacitinib treatment arms, response rates were “generally comparable,” they wrote. In addition, both deucravacitinib treatment arms demonstrated a larger proportion of patients meeting all MDA criteria domains at 16 weeks, with 22.9% in the 6 mg group, 23.9% in the 12 mg group and 7.6% among those who received placebo.
“As reported earlier, patients with PsA who were treated with deucravacitinib achieved a higher rate of MDA response vs. placebo after 16 weeks of treatment,” Kavanaugh and colleagues wrote. “The same trend in meeting MDA thresholds vs. placebo was observed for each of the seven individual MDA components, with responses overall comparable between the 6 mg QD and 12 mg QD doses of deucravacitinib.
“These results suggest that the MDA response achieved with deucravacitinib is comprehensive across an array of its component outcomes in PsA,” they added. “Longer term data from the ongoing, larger phase 3 studies in PsA will further characterize the full impact of deucravacitinib in these outcomes over time.”