Bristol Myers Squibb presents late-breaking Phase 2 data demonstrating the safety and efficacy of Deucravacitinib (BMS-986165) in Patients with Psoriatic Arthritis

Michelle Dryden November 9, 2020Comments Off

Deucravacitinib, the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases, showed significantly greater ACR 20 responses compared to placebo at 16 weeks and met all key secondary endpoints

Deucravacitinib was well-tolerated with a safety profile consistent with prior studies

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #ACR20—Bristol Myers Squibb (NYSE:BMY) today announced results from an ongoing Phase 2 study evaluating the safety and efficacy of deucravacitinib (BMS-986165) 6 mg or 12 mg once daily, compared with placebo in adults with active psoriatic arthritis. 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 6 mg (n=70) or 12 mg (n=67) demonstrated significantly greater ACR 20 responses versus placebo (n=66) at Week 16 (52.9% and 62.7% versus 31.8%, respectively) (p=0.0134 and p=0.0004, 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) will be presented today as part of the Late-Breaking Posters Session from 9:00-11:00 a.m. EST 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,” said lead study investigator, Philip Mease, M.D., 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 6 mg and 12 mg (-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 6 mg and 12 mg, 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 6 mg or 12 mg (24.3% and 32.8%, respectively) compared to placebo (10.6%) (p=0.0326 and p=0.0016, respectively).
Additionally, a significantly greater proportion of patients treated with deucravacitinib 6 mg or 12 mg 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 6 mg or 12 mg versus placebo, respectively, were nasopharyngitis (5.7%, 17.9%, 7.6%), rash (4.3%, 6.0%, 0%) and headache (7.1%, 1.5%, 4.5%).

“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,” said Mary Beth Harler, M.D., 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.”

About the Phase 2 Deucravacitinib Psoriatic Arthritis Trial

The study is an ongoing, one-year, randomized, double-blind, placebo-controlled (initial 16 weeks), multicenter, Phase 2 trial. Eligible patients had a psoriatic arthritis diagnosis for at least 6 months, met Classification for Psoriatic Arthritis (CASPAR) criteria and had active disease (at least 3 tender and at least 3 swollen joints), C reactive protein ≥3 mg/L (ULN, 5 mg/L) and at least 1 psoriatic lesion (≥2 cm). Patients had failed or were intolerant to at least 1 nonsteroidal anti-inflammatory drug, corticosteroid and/or conventional synthetic disease-modifying antirheumatic drug (csDMARD). Patients had failed up to 1 TNF inhibitor (≤30%). Patients were randomized 1:1:1 to deucravacitinib 6 mg once daily (QD), 12 mg QD, or placebo.

The primary endpoint was ACR 20 response at Week 16. Key secondary endpoints included improvement from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Physical Component Score (SF-36 PCS). Additional endpoints included the proportion of patients achieving ACR 50/70, HAQ-DI response (≥0.35 improvement from baseline), minimal disease activity, enthesitis resolution (Leeds Index) and adverse events.

Of 203 patients randomized, 180 (89.0%) completed 16 weeks of treatment. The mean age was 49.8 years, median psoriatic arthritis duration was 4.5 years, 65.0% of patients were using csDMARDs at baseline and 15.8% had failed or were intolerant to TNF inhibitors. More information can be found on www.clinicaltrials.gov (NCT03881059).

About Psoriatic Arthritis

Psoriatic arthritis is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (which occurs when the connective tissue between tendons or ligaments and bone becomes inflamed), dactylitis (inflammation of the fingers and toes) and psoriatic skin and nail lesions. Up to 30 percent of patients with psoriasis will develop psoriatic arthritis. In addition to the loss of physical function, pain and fatigue caused by psoriatic arthritis, the disease can significantly impact the mental and emotional well-being of patients. Patients with psoriatic arthritis are also at increased risk of developing serious comorbidities, including cardiovascular disease, metabolic syndrome and depression, as well as extraarticular manifestations of disease, such as inflammatory bowel disease.

About Deucravacitinib

Deucravacitinib (BMS-986165) is the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies across multiple immune-mediated diseases. Deucravacitinib’s selectivity is driven by a unique mechanism of action that is distinct from other kinase inhibitors. TYK2 is an intracellular signaling kinase that mediates signaling of IL-23, IL-12 and Type I IFN, which are naturally occurring cytokines involved in inflammatory and immune responses.

Deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. Deucravacitinib is not approved for any use in any country.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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