Amlitelimab shows promise as treatment for moderate to severe atopic dermatitis
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Key takeaways:
- Amlitelimab 250 mg with a loading dose of 500 mg caused the greatest EASI change from baseline (–32.1%).
- No safety concerns were identified and amlitelimab was well tolerated across all dosages.
Amlitelimab exhibited clinically meaningful efficacy over 24 weeks in the treatment of adults with moderate to severe atopic dermatitis, according to study results presented at the European Academy of Dermatology and Venereology 2023 Congress.
The positive results from the phase 2b STREAM-AD study also demonstrated an acceptable safety profile for amlitelimab (Sanofi), a fully human non-depleting monoclonal antibody.
"While we have made significant strides in the treatment of atopic dermatitis, there are patients who do not respond or incompletely respond to existing treatments and need alternative treatment options," Stephan Weidinger, MD, PhD, professor of dermatogenetics at the Christian-Albrechts-University and vice-head of the department of dermatology at the University Hospital Schleswig-Holstein in Germany, told Healio. "The data presented at EADV provide more detailed insight into amlitelimab’s potential and a signal to pursue a differentiated dosing regimen that could be very meaningful to patients with moderate to severe atopic dermatitis."
The double-blind, placebo-controlled phase 2b study included 390 adults with moderate to severe atopic dermatitis not adequately controlled with topical medications or for whom topical medications are not recommended.
The study was designed with two parts, the first being a 24-week treatment period and the second a still ongoing 36-week maintenance period. The results from the 24-week treatment period were presented in a late-breaker session at the European Academy of Dermatology and Venereology (EADV) Congress.
Patients in the study were randomly assigned to receive placebo or subcutaneous amlitelimab doses of 250 mg with a 500 mg loading dose, 250 mg without a loading dose, 125 mg without a loading dose or 62.5 mg without a loading dose every 4 weeks.
According to the study abstract, treatment with amlitelimab resulted in statistically significant improvements across all doses in the primary endpoint, which was a percentage change in EASI from baseline to week 16, compared with placebo.
The amlitelimab group taking 250 mg with a loading dose had the greatest change in EASI from baseline (–32.1%; 95% CI, –43.9 to –20.3) followed by 62.5 mg (–30.2; 95% CI, –41.9 to –18.5), 250 mg (–27.3; 95% CI, –39.1 to –15.6) and 125 mg (–22.2; 95% CI, –34 to –10.4).
According to the release, 22.1% and 45.5% of patients treated with 250 mg with a loading dose attained IGA 0/1 at weeks 16 and 24, respectively, vs. 5.1% and 11.4% of the placebo group (P = .0022 and P < .0001). A higher proportion of patients from the same group also achieved EASI 75 at weeks 16 and 24 (40.3% and 54.5%) compared with the placebo group (11.4% and 17.7%; P < .0001 for both)
No safety concerns were identified and amlitelimab was considered well tolerated across all dosages.
"These data form the basis for advancement into phase 3 clinical development in atopic dermatitis, which is expected to begin in the first half of 2024," Weidinger said.