The efficacy of longer-term lebrikizumab treatment in patients with moderate-to-severe atopic dermatitis who did not meet protocol-defined response criteria at week 16 in two randomized controlled clinical trials.

Abstract

Background: Lebrikizumab demonstrated statistically significant improvements in patients with moderate-to-severe atopic dermatitis at week 16 with a durable response up to week 52.

Objective: To investigate the efficacy of lebrikizumab-treated patients at 52 weeks who did not achieve the ADvocate1 and ADvocate2 protocol-defined response criteria (≥75% improvement in the Eczema Area and Severity Index [EASI 75] or Investigator Global Assessment [IGA] 0/1 with ≥2-point improvement without rescue medication) after 16 weeks.

Methods: This analysis includes observed data for patients who received lebrikizumab every 2 weeks during the induction period, did not achieve the protocol-defined response, and subsequently received open-label lebrikizumab treatment.

Results: At week 16, 38.1% of lebrikizumab-treated patients entered the escape arm due to not achieving the response criteria. However, most of these patients had achieved ≥50% improvement in EASI (58.1%) by week 16. At week 52, 36.1% achieved IGA 0/1 with ≥2-point improvement, 75.5% achieved EASI 75, 44.2% achieved ≥90% improvement in EASI, and 66.4% reported ≥4-point Pruritus Numeric Rating Scale improvement.

Limitations: This analysis assesses patients receiving open-label treatment with concomitant topical therapy allowed.

Conclusion: Lebrikizumab-treated patients not achieving the protocol-defined response at week 16 can benefit from the continuation of longer-term therapy.