Crisaborole demonstrated a favorable safety profile and improvement in all measures of efficacy, including overall disease severity, pruritus, and other signs of AD.

Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.

Objectives Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle‐controlled, 4‐week trials (ATMOS‐1 [NCT02530281] and ATMOS‐2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients. Methods Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD‐Children [ASDD‐C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4‐point improvement on ASDD/ASDD‐C Item 2 (a validated patient‐reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups. Results Six hundred and ninety‐seven patients were randomized in ATMOS‐1/ATMOS‐2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT‐treated pediatric vs older patients had comparable improvements in ASDD/ASDD‐C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2‐grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment‐emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation. Conclusions Topical, once‐daily GT improved disease severity (ASDD/ASDD‐C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment‐emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics.

not available. Disclosures: Study sponsored by Dermira Inc. Copyright 2018 SKIN

Interventions often result in statistically significant quality of life (QoL) improvement, but may not reach the threshold of clinical importance. The minimal clinically important difference (MCID) is the minimal score change of relevance clinically. We introduce the concept of 2MCID, a score change at least twice the usual threshold (i.e. 8 for DLQI), highlighting therapies changing by this higher threshold. A systematic review was conducted of the use of QoL instruments and of the impact of psoriasis treatments in randomized controlled trials (RCTs). 388 search terms were used to conduct searches in six databases adhering to PRISMA guidelines. Two assessors independently reviewed abstracts: a third resolved differences. Of 3646 screened publications, 99 articles (100 trials) involving 33,215 subjects met inclusion eligibility criteria. Of these 100 trials, 37 reported MCID; 32 DLQI, 10 SF-36 and 6 EQ-5D. 33 trials tested topical therapy, 18 systemic, 39 biologics, 9 phototherapy and 10 other interventions. For studies with treatment endpoint or assessment at 12 weeks, the interventions with the greatest average DLQI impact in each category were: Liquor Carbonis Distillate 15% (>1MCID, 5.8 pts), ciclosporin 3-5 mg/kg (>1MCID, 6.6 pts), secukinumab 300 mg (>2MCID, 11.4 pts), PUVAsol 0.6 mg/kg + isotretinoin 0.5 mg/kg (>2MCID, 11.2 pts) and educational programme (1MCID, 4 pts). Clolobetasol spray 0.05% (8 points, 4 weeks), ustekinumab 90 mg (8, 12), etanercept 50 mg (8.7, 24) and MTX 15 mg (8.7, 16) also reached 2MCID. The concept of '2MCID' adds meaning to score change when comparing therapies and results across different QoL instruments, though this requires further validation. However secukinumab and PUVAsol + isotretinoin both reached 2MCID at 12 weeks, according well with clinical experience.