were taking other medications potentially causing gastrointestinal upset. Of 9 patients reporting pain, 4 had a history of joint or muscle pain and 4 experienced pain <4 weeks after brodalumab initiation.
Regarding other events of clinical interest, there were 3 reports of malignancy (hepatic, lung, and ovarian; 0.01 events per PY), all considered unrelated to brodalumab. There were 4 reports of serious infections (0.02 events per PY) possibly related to brodalumab, 2 from the same patient (no follow-up information was provided despite multiple requests). There were 2 events of fungal infection (0.01 events per PY) but no reports of serious fungal infection. One nonserious event of oral fungal Candida infection was reported; brodalumab was discontinued and symptoms resolved. A nonserious event of vulvovaginal mycotic Candida infection was reported; brodalumab was maintained and symptoms resolved (Figure 1).
One-year pharmacovigilance reporting for brodalumab revealed that the most commonly reported AE was psoriasis flare. There were few reports of depression and no reports of suicide attempts, completed suicides, or serious fungal infections. A limitation of this report is that it did not capture all AEs, only those reported to Ortho Dermatologics.
DISCLOSURES
Dr. Lebwohl is an employee of Mount Sinai and receives research funds from: Abbvie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen Research & Development, LLC, Leo Pharmaceutucals, Ortho Dermatologics, Pfizer, and UCB, Inc.and is a consultant for Aditum Bio, Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., BMD skincare, Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, Kyowa Kirin, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica. Dr Leonardi is a consultant for AbbVie, Amgen, Boehringer Ingelheim, Dermira, Eli Lilly, Janssen, LEO Pharma, Pfizer, Sandoz, UCB, and Vitae; an investigator for Actavis, AbbVie, Allergan, Amgen, Boehringer Ingelheim, Celgene, Coherus, Cellceutix, Corrona, Dermira, Eli Lilly, Galderma, Glenmark, Janssen, LEO Pharma, Merck, Novartis, Novella, Pfizer, Sandoz, Sienna, Stiefel, UCB, and Wyeth; and a speaker for AbbVie, Celgene, Novartis, Sun Pharmaceutical, and Eli Lilly. Dr Wu is an investigator for AbbVie, Amgen, Eli Lilly, Janssen, and Novartis; a consultant for AbbVie, Almirall, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Dr. Reddy's Laboratories, Eli Lilly, Janssen, LEO Pharma, Novartis, Promius Pharma, Regeneron, Sun Pharmaceutical, UCB, and Bausch Health; and a speaker for AbbVie, Celgene, Novartis, Regeneron, Sanofi Genzyme, Sun Pharmaceutical, UCB, and Bausch Health. Dr Yamauchi is an investigator, speaker, and consultant for AbbVie, Amgen, Bausch Health, Novartis, and Janssen and a consultant for Boehringer Ingelheim, Pfizer, and Sun Pharmaceutical. Dr Rawnsley and Abby Jacobson are employees of Ortho Dermatologics. Mohammed Merchant and Binu Alexander are employees of Bausch Health.
Funding sources: This study was sponsored by Ortho Dermatologics. Medical writing support was provided by MedThink SciCom and funded by Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.
ACKNOWLEDGMENT
This study was sponsored by Ortho Dermatologics. Medical writing support was provided by MedThink SciCom and funded by Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.
References
1. Papp KA, Leonardi C, Menter A, et al. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014;71:1183- 1190.e3.
2. Papp KA, Reich K, Paul C, et al. A prospective phase III, randomized, doubleblind, placebo-controlled study of brodalumab in patients with moderate-tosevere plaque psoriasis. Br J Dermatol. 2016;175:273-286.
3. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373:1318-1328.
4. Lebwohl MG, Papp KA, Marangell LB, et al. Psychiatric adverse events during treatment with brodalumab: analysis of psoriasis clinical trials. J Am Acad Dermatol. 2018;78:81-89.e5.
Mark Lebwohl MD Lebwohl@aol.com
