Amlitelimab maintains patient response in atopic dermatitis following treatment cessation

Key takeaways:

• Across dose-arms, 71.9% of patients who continued treatment and 57% of patients withdrawn from treatment maintained IGA 0 or 1.
• EASI-75 was also maintained by 69% and 61.6% of these groups, respectively.

Adults treated with amlitelimab showed sustained improvement in their moderate to severe atopic dermatitis over the span of 28 weeks, Sanofi announced in a press release.

The study was designed with two parts, the first being a 24-week treatment period and the second being the current, ongoing 28-week maintenance period. These 28-week results, derived from the second part of the study, were presented in a late-breaker session at the American Academy of Dermatology Annual Meeting.

“The phase 2b data demonstrate sustained improvement of signs and symptoms for 28 weeks in adults with moderate to severe AD who previously responded to amlitelimab and continued treatment,” Karl Yen, MD, MMSc, global project head at Sanofi, told Healio. “Notably, high responder rates were also observed in participants who were taken off amlitelimab, suggesting potential durable off-drug efficacy.”

In the first part of the study, patients 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. In this second part of the study, patients who previously achieved a 75% improvement in EASI 75 or IGA 0 or 1 were randomly assigned to continue amlitelimab or withdraw from the drug.

Of those who continued treatment with 250 mg every 4 weeks with a 500 mg loading dose, 69.2% maintained EASI 75 and/or IGA 0 or 1. Similarly, 58.8% of patients withdrawn from treatment maintained the same.

A pooled analysis of all the dose-arms showed that 71.9% of patients with continued treatment and 57% of patients withdrawn from treatment maintained IGA 0 or 1. EASI 75 was also maintained by 69% and 61.6% of these groups, respectively.

“It’s unprecedented to see this type of durability of clinical response among patients who were taken off amlitelimab treatment,” Yen told Healio. “It is generally expected that discontinuation of a treatment would result in a decline in efficacy. However, a significant proportion of patients maintained improved IGA 0 or 1 and/or EASI 75 scores even without ongoing treatment.”

Yen went on to explain that this indicates amlitelimab may provide modulation of immune response and durable disease control via the blockade of OX40L, a non-T-cell depleting mechanism, even after withdrawal.

“This supports the evaluation of a less frequent, every 12-week dosing regimen, which is currently being investigated in the ongoing phase 3 clinical trial program, OCEANA,” he said. “If approved, amlitelimab could provide a meaningful new treatment option for patients with moderate to severe AD, addressing an unmet need for durable and less frequent treatment options.”

Editor's note: On June 18, the maintenance period was corrected to reflect 28 weeks. The editors regret the error.