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Efficacy data

ISGA scale efficacy results

Percentage of patients with ISGA score of Clear (0) or Almost Clear (1) by Day 293

Approximately half of Staquis® patients were Clear (0) or Almost Clear (1) by Day 29.3

 

Secondary endpoint: time to success in ISGA score (pooled data)3
Staquis® helped some patients achieve Clear (0) or Almost Clear (1) skin faster than vehicle3

  • On Day 8, success in ISGA score was achieved by more patients treated with Staquis® than with vehicle10
  • Success in ISGA score was achieved by an almost 3x higher percentage of Staquis®-treated patients vs vehicle-treated patients by Day 810

 

Pruritus

A significantly greater proportion of patients treated with crisaborole demonstrated improvement at earliest assessment (day 2; p = 0.013) and early improvement of pruritus at day 6 (p < 0.001) than patients given vehicle

Proportion of patients achieving improvement in pruritus. Improvement on day 2 and early improvement in pruritus on day 6

 

Other AD symptom efficacy results

Improvement in other physical signs of AD

Staquis® treatment improved other physical signs of AD3

Pooled analysis

  • Significantly more Staquis®-treated patients achieved improvement in signs of AD (erythema, exudation, excoriation, induration/papulation and lichenification) vs vehicle-treated patients3

Improvement in QoL

Staquis® treatment delivered clinically meaningful improvement in QoL for some patients6

  • Greater mean change from baseline experienced by Staquis®-treated children in CDLQI score compared with emollient-rich vehicle alone (-4.6 vs -3.0, respectively; P<0.001)6
  • Greater mean change in DLQI score from baseline experienced by Staquis®-treated patients ≥16 years compared with emollient-rich vehicle alone (-5.2 vs -3.5, respectively; P=0.016)6

Both CDLQI and DLQI scores for Staquis® treated patients exceeded the minimal clinically important difference (MCID), with a significant improvement by Day 29.6

Post-hoc analysis of pooled data showed QoL improvements with Staquis®-treated vs vehicle-treated patients, in several domains of CDLQI and DLQI:6