Weekly Cendakimab 720 mg Linked to Reduced EASI Scores in Atopic Dermatitis

Jonathan Silverberg, MD, PhD, MPH
Credit: George Washington University School of Medicine

Results of a phase 2, placebo-controlled trial detail the potential of cendakimab, an interleukin (IL)-13 inhibitor from Bristol Myers Squibb, in the management of moderate to severe atopic dermatitis.

Conducted among a cohort of 202 patients with atopic dermatitis from nearly half a dozen countries, results of the study suggest use of cendakimab 720 mg weekly was associated with a statistically significant reduction in mean percentage change in Eczema Area and Severity Index (EASI) scores at week 16 relative to placebo therapy.¹

“The results of this randomized clinical trial indicated that cendakimab was effective, generally safe, and well-tolerated in patients with moderate to severe [atopic dermatitis],” wrote investigators.¹ “The primary end point was met with a significant reduction in Eczema Area and Severity Index scores with 720 mg, once weekly at week 16.”

Led by Jonathan Silverberg, MD, MPH, professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Science, the phase 2 trial was designed as a multicenter, double-blind, placebo-controlled, parallel-group, dose-ranging study and randomized eligible patients in a 1:1:1:1 ratio to receive subcutaneous cendakimab 360 mg every 2 weeks, 720 mg every 2 weeks, 72 mg once weekly, or placebo therapy for 16 weeks. For inclusion patients were required to complete a 4-week screening period and have moderate to severe atopic dermatitis as well as an inadequate response to topical medications.¹

In total, 221 patients from 69 sites in 5 countries underwent randomization and 220 received study drug. At baseline, this cohort had a mean age of 37.7 (SD, 13.0) years, 61.8% were White, and 43.2% were women. Assessment of disease characteristics indicated the mean EASI score was 28.4 (SD, 10.8), the mean time from disease onset was 26.3 (SD, 15.5) years, and 33.6% of patients had a vIGA score indicative of severe disease. Investigators pointed out there were no clinically meaningful differences in baseline characteristics among the treatment arms.¹

The primary outcome of interest for the trial was the mean percentage change in EASI scores from baseline to week 16. The trial also included multiple secondary outcomes of interest, such as safety outcomes as well as the proportion of patients with a vIGA-AD score of clear or almost clear with a 2-point or greater reduction at week 16 and the proportion of patients with a 75% or greater improvement in EASI scores at week 16.¹

Results of the trial indicated the cendakimab 720 mg once weekly arm was the only intervention arm to meet the primary efficacy endpoint. However, investigators pointed out statistical significance was missed for cendakimab 720n mg every 2 weeks and, although it was not claimed because the hierarchical testing interrupted, the difference in treatment effect observed with the 360 mg every 2 weeks dose (-16.3; nominal P = .03 vs placebo) was comparable to the 720 mg once weekly group (-21.8).¹

Safety analyses of the trial indicated treatment-emergent adverse events were reported by 74.1% of the 720 mg once weekly group, 74.5% of the 720 mg every 2 weeks group, 69.1% of the 360 mg every 2 weeks group, and 73.2% of the placebo group. Among the 9 patients who discontinued treatment as a result of such an event, 7.4% received 720 mg once weekly, 3.6% received 720 mg every 2 weeks, 1.8% received 360 mg every 2 weeks, and 3.6% received placebo.¹

Despite a positive finding from the highest dose of the agent, Bristol Myers Squibb announced it had chosen not to further pursue development of cendakimab in atopic dermatitis in an earnings call in February 2023, citing the agent’s inability to differentiate itself from other IL-13 inhibitors and the competition within the disease landscape. However, according to the company’s website as of July 17, 2024, the agent is still being examined for use in management of eosinophilic esophagitis and eosinophilic gastroenteritis.^2,3

References:

Motley Fool Transcribing. Bristol-Myers Squibb (BMY) Q4 2022 earnings call transcript. The Motley Fool. February 2, 2023. Accessed July 17, 2024. https://www.fool.com/earnings/call-transcripts/2023/02/02/bristol-myers-squibb-bmy-q4-2022-earnings-call-tra/.

Bristol Myers Squibb. Pharmaceutical Research and Development Pipeline - Bristol myers squibb. Bristol Myers Squibb. April 25, 2024. Accessed July 17, 2024. https://www.bms.com/researchers-and-partners/in-the-pipeline.html.