PMID- 29373924 OWN - NLM STAT- MEDLINE DCOM- 20181211 LR - 20181211 IS - 1615-7109 (Electronic) IS - 1203-4754 (Linking) VI - 22 IP - 3 DP - 2018 May/Jun TI - Efficacy and Safety of Apremilast Monotherapy for Moderate to Severe Psoriasis: Retrospective Study. PG - 290-296 LID - 10.1177/1203475418755982 [doi] AB - BACKGROUND: Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. OBJECTIVE: Assess the efficacy and safety of apremilast monotherapy in real-world practice. METHODS: A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a >/=75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting >/=1 AE at 16 weeks. RESULTS: Thirty-four patients were included. EFFICACY: 19 patients (55.9%) achieved PASI-75 or PGA 0/1. SAFETY: 23 patients (67.6%) experienced >/=1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). CONCLUSION: Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study. FAU - Ighani, Arvin AU - Ighani A AUID- ORCID: 0000-0002-2164-3609 AD - 1 Faculty of Medicine, University of Toronto, Toronto, ON, Canada. FAU - Georgakopoulos, Jorge R AU - Georgakopoulos JR AD - 2 Schulich School of Medicine and Dentistry, Western University, London, ON, Canada. FAU - Zhou, Linda L AU - Zhou LL AD - 3 Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. FAU - Walsh, Scott AU - Walsh S AD - 4 Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada. FAU - Shear, Neil AU - Shear N AUID- ORCID: 0000-0001-9151-1145 AD - 4 Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada. FAU - Yeung, Jensen AU - Yeung J AD - 4 Division of Dermatology, Department of Medicine, University of Toronto, Toronto, ON, Canada. LA - eng PT - Journal Article DEP - 20180126 PL - United States TA - J Cutan Med Surg JT - Journal of cutaneous medicine and surgery JID - 9614685 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 4Z8R6ORS6L (Thalidomide) RN - UP7QBP99PN (apremilast) SB - IM MH - Adult MH - Aged MH - Anti-Inflammatory Agents, Non-Steroidal/adverse effects/*therapeutic use MH - Female MH - Humans MH - Male MH - Middle Aged MH - Psoriasis/*drug therapy/pathology MH - Retrospective Studies MH - Severity of Illness Index MH - Thalidomide/adverse effects/*analogs & derivatives/therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - apremilast OT - clinical practice OT - monotherapy OT - phosphodiesterase inhibitor OT - plaque psoriasis EDAT- 2018/01/28 06:00 MHDA- 2018/12/12 06:00 CRDT- 2018/01/28 06:00 PHST- 2018/01/28 06:00 [pubmed] PHST- 2018/12/12 06:00 [medline] PHST- 2018/01/28 06:00 [entrez] AID - 10.1177/1203475418755982 [doi] PST - ppublish SO - J Cutan Med Surg. 2018 May/Jun;22(3):290-296. doi: 10.1177/1203475418755982. Epub 2018 Jan 26.