Results from an ongoing Phase 2 study evaluating the safety and efficacy of Bristol Myers Squibb's deucravacitinib (BMS-986165) 6mg or 12mg once daily, compared with placebo in adults with active psoriatic arthritis (PsA). The study met the primary endpoint of at least a 20 percent improvement in signs and symptoms of disease (ACR 20) at Week 16. Patients treated with deucravacitinib 6mg (n=70) or 12mg (n=67) demonstrated significantly greater ACR 20 responses versus placebo (n=66) at Week 16 (52.9 percent and 62.7 percent versus 31.8 percent, respectively). Treatment with deucravacitinib also led to significant improvements on key secondary endpoints relevant for patients, including improvement from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and change from baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 Item (SF-36) Questionnaire.
These results (Abstract #L03) were presented as part of a Late-Breaking Posters Session at the American College of Rheumatology (ACR) Convergence 2020.
“The positive data from this Phase 2 study evaluating the safety and efficacy of deucravacitinib support the ongoing evaluation of this novel oral therapy for people living with the debilitating effects of psoriatic arthritis,” says lead study investigator, Philip Mease, MD, director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and clinical professor at the University of Washington School of Medicine, Seattle. "Many patients with psoriatic arthritis are not adequately treated, reinforcing the need for safe and effective oral treatment options that may help control the range of symptoms experienced as a result of this disease."
At Week 16, all key secondary endpoints were achieved, with significant improvements observed in additional secondary endpoints evaluated in the trial. Findings include:
- Improvement from baseline in the HAQ-DI for deucravacitinib 6mg and 12mg (-0.37, -0.39) compared to placebo (-0.11) (p=0.002 and p=0.0008, respectively).
- Change from baseline in the PCS Score of the SF-36 Questionnaire at Week 16, which was 5.6 and 5.8 for deucravacitinib 6mg and 12mg, respectively, versus 2.3 for placebo (p=0.0062 and p=0.0042, respectively).
- Significantly greater improvements in ACR 50 response for patients treated with deucravacitinib 6mg or 12mg (24.3 percent and 32.8 percent, respectively) compared to placebo (10.6 percent) (p=0.0326 and p=0.0016, respectively).
- Additionally, a significantly greater proportion of patients treated with deucravacitinib 6mg or 12mg achieved the following secondary endpoints compared to placebo:
- HAQ-DI response, defined as achievement of HAQ-DI minimal clinically important difference 0.35 (p=0.0019 and p=0.0015, respectively).
- Enthesitis resolution (enthesitis occurs when the connective tissue between tendons or ligaments and bone becomes inflamed; measured by the Leeds Index) (p=0.0138 and p=0.0393, respectively).
- Minimal disease activity (defined as meeting key disease criteria related to joints, skin lesions, pain, global disease activity and health assessment questionnaire scores) (p=0.0119 and p=0.0068, respectively).
In this trial, deucravacitinib was well-tolerated and the safety profile was similar to that observed in the previously reported Phase 2 psoriasis trial. In the study, there were no serious adverse events reported in deucravacitinib-treated patients. The most common treatment-emergent adverse events for patients who received deucravacitinib 6mg or 12mg versus placebo, respectively, were nasopharyngitis, rash, and headache.
“These data, along with the recent positive Phase 3 data evaluating deucravacitinib in patients with moderate to severe plaque psoriasis, support our continued study of deucravacitinib and bring us one step closer to further advancing care for people living with psoriatic disease,” says Mary Beth Harler, MD, head of Immunology and Fibrosis Development, Bristol Myers Squibb. “As the first and only novel, oral, selective TYK2 inhibitor in clinical studies across multiple immune-mediated diseases, deucravacitinib represents Bristol Myers Squibb’s deep scientific commitment to investigating novel targets that may lead to the development of innovative treatments for immune-mediated diseases."