Category: Professional Posters
Purpose: Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). Efficacy and safety of crisaborole were established in 2 phase 3 trials (NCT02118766, NCT02118792), and additional analyses showed that crisaborole produced clinically relevant improvement in AD-associated pruritus. This pooled, post hoc analysis of the 2 phase 3 trials assessed pruritus outcomes stratified by baseline AD severity (mild or moderate) per Investigator’s Static Global Assessment (ISGA).
Methods: Patients ≥2 years with mild-to-moderate AD were randomly assigned 2:1 to receive crisaborole (N=1016) or vehicle (N=506) twice daily for 28 days. Pruritus was measured using the Severity of Pruritus Scale (SPS; a 4-point rating scale ranging from 0 [no itching] to 3 [bothersome itching/scratching that disturbs sleep]), captured twice daily via electronic diary. Pruritus success was defined as weekly average SPS score ≤1 with ≥1-point improvement from baseline. The proportion of patients with ≥1-point improvement from baseline in weekly average SPS score was also assessed. Time to pruritus success was analyzed using daily average SPS score. Only patients with both average baseline and post-baseline assessments were included.
Results: All results presented as crisaborole versus vehicle. When stratified by baseline ISGA, mean baseline SPS score was 1.60 (N=297) versus 1.57 (N=138) in mild AD and 1.96 (N=465) versus 1.89 (N=230) in moderate AD. Significant differences in proportion of patients achieving pruritus success were observed from week 1 (17.5% vs 8.7%, P=0.0068) through week 4 (37.4% vs 25.0%, P=0.0094) in mild AD and from week 1 (19.1% vs 10.0%, P=0.0007) through week 4 (34.8% vs 18.4%, P < 0.0001) in moderate AD. Median time to pruritus success was 5 days (95% CI, 4-6) versus 8 days (4-13; P=0.1093) in mild AD and 4 days (3-5) versus 11 days (7-17; P < 0.0001) in moderate AD. Significant differences in proportion of patients with ≥1 point improvement in pruritus were observed from week 1 (25.9% vs 14.5%, P=0.0036) through week 4 (42.7% vs 28.1%, P=0.0032) in mild AD and from week 1 (32.7% vs 20.4%, P=0.0004) through week 4 (45.9% vs 31.4%, P=0.0003) in moderate AD. Median time to ≥1-point improvement in pruritus was 3 days (95% CI, 3-4) versus 6 days (4-12; P=0.0583) for mild AD and 3 days (2-3) versus 4 days (3-6; P=0.0002) for moderate AD.
Conclusion: This post hoc analysis shows that patients ≥2 years with mild or moderate AD treated with crisaborole experienced statistically significant improvement in pruritus outcomes versus vehicle through week 4.