Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y [ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] U niversity Children's Hospital, Zurich, Switzerland; 5 AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany; 6 AbbVie Inc., North Chicago, Illinois I ntroduction: This study (clinicaltrials.gov NCT01251614) evaluated safety and efficacy of TNF- alpha inhibitor adalimumab (ADA) versus methotrexate (MTX) treatment i n pediatric patients with chronic plaque psoriasis. Results from the 16- week initial treatment period (Period A) are presented. Methods: This multi-site international study included four periods. Period A: 16-week double- blind treatment; 1:1:1 randomization to initial 0.8mg/kg ADA up to 40mg, then every other week from Week 1; initial 0.4mg/kg ADA up to 20mg, then every other week from Week 1; or 0.1 to 0.4mg/kg MTX weekly up to 25mg/week. Period B: treatment withdrawal for treatment responders. Period C: ADA retreatment. Period D: 52-week treatment and follow-up. Eligibility included patient age-range 4 to 18 years, Physician's Global Assessment (PGA) ≥4 or; body surface area involved >20% or; Psoriasis Area Severity Index (PASI) >20; or PASI >10 plus at least one of the following: active psoriatic arthritis unresponsive to NSAIDS, clinically relevant facial, genital, or hand and/or foot involvement, or Children's Dermatology Life Quality Index >10. Primary efficacy endpoints, ≥PASI75 response and PGA clear or minimal (0/1) at Week 16 (ADA–0.8mg/kg vs. MTX), were evaluated for the intent- to-treat population; patients with missing data were imputed as nonresponders. Safety was evaluated for all patients who received at least one dose of study drug. Results: Of 114 enrolled (MTX n=37, ADA–0.4mg/kg n=39, ADA- 0.8mg/kg n=38), 57 percent were female; 90 percent were white. Mean age was 13.0 years (SD 3.76), range 5 to 18. Body mass index (BMI) distribution by age- and sex-adjusted percentiles was 4.4 percent (<5th, underweight), 59.6 percent (5th to <85th, normal weight), 14.9 percent (85th to <95th, overweight), 21.1 p ercent (≥95th, obese). A statistically significantly higher proportion of ADA–0.8mg/kg patients achieved PASI75 response at Week 16 (22/38, 57.9%) versus MTX patients (12/37, 3 2.4%; [95% CI: -47.2, -3.7] p=0.027). Approximately 20 percent more ADA- 0.8mg/kg patients achieved PGA 0/1 response at Week 16 (23/38, 60.5%) versus MTX patients (15/37, 40.5%; [ 95% CI: -42.2, 2.2] p=0.083). Treatment-emergent adverse events (TEAEs) were reported by 73.7 percent (84/114) in Period A: 75.7 percent (28/37) MTX; 76.9 percent (30/39) ADA–0.4mg/kg; 68.4 percent (26/38) ADA–0.8mg/kg. TEAEs of infection were reported by 54.1 percent (20/37) MTX; 56.4 percent (22/39) ADA–0.4mg/kg; 47.4 percent (18/38) ADA–0.8mg/kg; serious TEAEs were reported by only the ADA–0.4mg/kg patients, 7.7 percent (3/39) during Period A. Limitation: The number of enrolled patients was low. Conclusion: After 16 weeks of treatment, adalimumab 0.8mg/kg every-other-week demonstrated significant and clinically meaningful efficacy outcomes over methotrexate in this population. Adalimumab treatment had a similar safety profile to methotrexate, and no new safety risks were identified. The Aerosol Foam Formulation Of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate Is Efficacious In Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies Presenters: 1 Linda Stein Gold; 2 Mark Lebwohl; 3 Alan Menter; 4 John Villumsen; 4 Monika Rosén; 5 John Koo Affiliations: 1 Henry Ford Health System, Detroit, MI; 2 Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY; 3 Baylor University Medical Center, Dallas, TX; 4 LEO Pharma A/S, Ballerup, Denmark; 5 Department of Dermatology, University of California, San Francisco, CA Background: An innovative alcohol-free aerosol foam formulation of calcipotriene 0.005% (Cal)/betamethasone dipropionate 0 .064% (BD) was developed as a new treatment option for patients with psoriasis. Phase 2/3 studies have shown that the aerosol foam formulation is efficacious for the t reatment of psoriasis vulgaris. Objective: Data from three Phase 2/3 studies were pooled to increase the precision in the estimate of the effect size and to evaluate the efficacy of C al/BD aerosol foam for 4 weeks in patients with psoriasis. Methods: The three pooled studies enrolled patients aged ≥18 years with mild–severe psoriasis of the body (NCT01536886, NCT01536938, NCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. All analyses were descriptive. Primary endpoint: proportion of patients clear/almost clear with ≥2-step improvement in disease severity at Week 4 (according to physician's global assessment; defined as treatment success). Additional endpoints: proportion of patients with treatment success at Week 1; modified (excluding head) psoriasis area and severity index (mPASI) at Weeks 1 and 4. Tertiary endpoints: proportion of patients with ≥75% reduction in mPASI (PASI75) at Week 4; change in itch (according to visual analog scale [VAS]) at Weeks 1 and 4. Missing values were imputed by last-observation-carried-forward, except for itch. Results: Overall, 1,104 patients were randomized across the three studies to Cal/BD aerosol foam (n=564), Cal aerosol foam (n=101), BD aerosol foam (n=101), aerosol foam vehicle (n=152), Cal/BD ointment (n=135), or ointment vehicle (n=51). All patients were included in the full efficacy analysis set (intent-to- treat population). Overall completion rate was 95 percent. At Week 4, 51 percent of patients using Cal/BD aerosol foam achieved treatment success, a higher proportion than all other treatment groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%); treatment success rate was also superior for Cal/BD aerosol foam at Week 1. Greater percentage mean S 1 2

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