668 - Improvements in itch and sleep disturbance are maintained up to week 48 with nemolizumab plus TCS/TCI treatment in patients with moderate-to-severe atopic dermatitis: results from two global phase 3 pivotal studies (ARCADIA 1 and ARCADIA 2)

Abstract Background Treatment with nemolizumab plus topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) achieved improvements in itch and sleep (measured using Peak Pruritus Numerical Rating Scale and Sleep Disturbance Numerical Rating Scale) at Week (W) 16 and maintained them up to W48 in patients with moderate-to-severe AD.1,2 Objectives To evaluate the efficacy of nemolizumab in maintaining itch and sleep responses (using SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale [VAS] Pruritus and SCORAD VAS Sleep) over 48 weeks in patients with moderate-to-severe AD. Methods We analyzed 32-week maintenance data pooled from two double-blinded, placebo-controlled, phase 3 studies (ARCADIA-1 and ARCADIA-2). Clinical responders (those achieving IGA 0/1 or EASI-75 at W16) were re-randomized (1:1:1) to receive nemolizumab 30mg every 4 weeks (nemolizumab-Q4W), nemolizumab 30mg every 8 weeks (nemolizumab-Q8W), or placebo Q4W (nemolizumab-withdrawal arm) subcutaneously, all with TCS and/or TCI up to W48. Results At W48, response rates for ≥4-point improvement in SCORAD VAS Pruritus were maintained in nemolizumab-Q4W (72.8%, p<0.0001) and nemolizumab-Q8W (66.9%, p≤0.001) vs placebo (49.1%) groups. Similarly, response rates for ≥4-point improvement in SCORAD VAS Sleep were maintained in nemolizumab-Q4W (61.5%, p<0.001) and nemolizumab-Q8W (56.2%, p<0.05) vs placebo (43.2%) groups at W48. Response rates for SCORAD VAS Pruritus-75 (≥75% improvement in VAS Pruritus from initial baseline) were also maintained in nemolizumab-Q4W (63.3%, p<0.0001) and nemolizumab-Q8W (58.6%, p<0.0001) vs placebo (37.3%) groups at W48. Similar maintenance of response rates for SCORAD VAS Sleep-75 (≥75% improvement in VAS Sleep from initial baseline) was noted in nemolizumab-Q4W (60.4%, p<0.01) and nemolizumab-Q8W (56.8%, p<0.05) vs placebo (43.8%) groups at W48. Conclusions Treatment with nemolizumab plus TCS/TCI maintained rate of improvements in itch and sleep through W48 in patients who achieved clinical response at W16. The Q8W regimen was similar to Q4W in maintenance of the rate of itch and sleep response.