Lawrence F Eichenfield1, Robert S Call2, Douglass W Forsha3, Joseph Fowler4, Adelaide A Hebert5, Mary Spellman6, Linda F Stein Gold7, Merrie Van Syoc8, Lee T Zane9, Eduardo Tschen10. 1. Division of Pediatric Dermatology, Rady Children's Hospital, San Diego, California; Departments of Dermatology and Pediatrics, University of California, San Diego, California. Electronic address: leichenfield@rchsd.org. 2. Clinical Research Partners, Richmond, Virginia. 3. Jordan Valley Dermatology and Research Center, West Jordan, Utah. 4. Dermatology Specialists Research, Louisville, Kentucky. 5. Department of Dermatology, UTHealth McGovern Medical School-Houston, Houston, Texas. 6. Paid consultant to Anacor Pharmaceuticals Inc, Palo Alto, California. 7. Henry Ford Health System, Detroit, Michigan. 8. Pfizer Inc, New York, New York. 9. Anacor Pharmaceuticals Inc, acquired by Pfizer Inc, New York, New York. 10. Academic Dermatology Associates, Albuquerque, New Mexico.
Abstract
BACKGROUND: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease. OBJECTIVE: To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302). METHODS: Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed. RESULTS: During the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs. LIMITATIONS: Long-term efficacy was not analyzed. CONCLUSION: Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.
BACKGROUND: Long-term topical treatment is often required for atopic dermatitis (AD), a chronic inflammatory skin disease. OBJECTIVE: To assess the long-term safety results from a multicenter, open-label, 48-week safety study (AD-303) of patients (N = 517) ≥2 years of age with mild to moderate AD who continued crisaborole treatment, a topical phosphodiesterase-4 inhibitor, after completing a 28-day phase 3 pivotal study (AD-301, AD-302). METHODS: Global disease severity was assessed in patients every 4 weeks, and if assessed as mild or greater, a 28-day treatment period with crisaborole applied twice daily was initiated. Adverse events (AEs), including treatment-emergent AEs (TEAEs), and serious AEs were analyzed. RESULTS: During the pivotal studies and AD-303, 65% of patients reported ≥1 TEAE, most of which were mild (51.2%) or moderate (44.6%) and considered unrelated to treatment (93.1%). The frequency and severity of TEAEs were consistent. The most frequently reported treatment-related AEs (overall, 10.2%) were dermatitis atopic (3.1%), application-site pain (2.3%), and application-site infection (1.2%). Nine patients (1.7%) discontinued the long-term study because of TEAEs. LIMITATIONS: Long-term efficacy was not analyzed. CONCLUSION:Crisaborole ointment had a low frequency of treatment-related AEs over 48 weeks of treatment of patients with AD.
Authors: Steven R Feldman; Linda S Cox; Lindsay C Strowd; Robert A Gerber; Steven Faulkner; Debra Sierka; Timothy W Smith; Joseph C Cappelleri; Mark E Levenberg Journal: Am Health Drug Benefits Date: 2019-04