Figure. Exposure-adjusted clinical events of special interest, as deemed by the reporter or company, within the 4-year reporting period. Exposure-adjusted event rate per 100 PYs is the number of events per 45.63 PYs of exposure. IBD, inflammatory bowel disease; PY, patient-year. Clinical events of special interest • Exposure-adjusted event rates are reported in the Figure Infections • Of 102 serious infections reported, only 3 were considered related to brodalumab • Although no serious fungal infections were reported, 1 new fungal infection (onychomycosis) led to the patient discontinuing brodalumab; there were no new reports of oral candidiasis • One case of tuberculosis, 24 cases of confirmed COVID-19, and 2 cases of suspected COVID-19 were reported Inflammatory bowel disease • No new cases of Crohn’s disease were reported (1 case was previously reported in a patient who had symptomatic history before brodalumab initiation) • One case of ulcerative colitis, which was not suspected to be related to brodalumab, was reported Malignancies • 37 malignancies were reported in 32 patients (0.81 events/ 100 PYs); none were considered related to brodalumab Depression and suicide • There were 4 new depression cases reported during year 4; no causality assessments were provided • There were no completed suicides throughout the 4-year report and no new suicide attempts reported (there was 1 previously reported suicide attempt, with no indicated causal relationship between brodalumab and the patient’s attempted self-harm) SYNOPSIS • Brodalumab is an interleukin-17 receptor A antagonist indicated for moderate-to-severe plaque psoriasis in adult patients with loss of or no response to alternative systemic therapies1 – Brodalumab has a boxed warning for suicidal ideation and behavior in the United States, even though pivotal clinical trials and recent pharmacovigilance data do not confirm a causal relationship1-3 – No completed suicides and 1 suicide attempt by a patient with a history of depression occurred during the initial 3-year pharmacovigilance reporting period3 – Arthralgia was the most common treatment-specific adverse event (AE) in the 2- and 3-year pharmacovigilance reports3,4 METHODS • Pharmacovigilance data reported to Ortho Dermatologics by US patients and healthcare providers were compiled from August 15, 2017, through August 14, 2021 • The most common AEs listed in the brodalumab package insert (incidence ≥1%; arthralgia, headache, myalgia, influenza, diarrhea, oropharyngeal pain, nausea, injection-site reactions, fatigue, neutropenia, and Tinea infections) and AEs of special interest were assessed as exposure-adjusted rates per 100 patient-years (PYs) • Brodalumab exposure was estimated as the time between the first and last prescription-dispensing authorization dates. Patients with the same initial and last prescription-dispensing authorization date were excluded RESULTS Commonly reported AEs from package insert • Data were collected from 4019 US patients and exposure was estimated as 4563 PYs • Of 2118 unique AE cases, 22% were reported by healthcare providers and 78% by patients • Common AEs are listed in the Table; similar to previous reports,3,4 arthralgia was the most commonly reported AE within the 4-year reporting period (115 cases; 2.52 events/ 100 PYs) – Of arthralgia cases, 53 and 25 patients continued and discontinued treatment, respectively, whereas treatment status was unknown for 37 patients – Of the 4 new cases of arthralgia since the 3-year report, 3 patients were temporarily off brodalumab when their joint pain recurred • There were no new reports of injection-site reactions, fatigue, or neutropenia since the 3-year report Brodalumab: 4-Year US Pharmacovigilance Report Mark Lebwohl,1 Andrea Murina,2 George Han,3 Abby Jacobson4 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Tulane University School of Medicine, New Orleans, LA; 3Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY; 4Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ OBJECTIVE • To review the US pharmacovigilance data over a 4-year reporting period to provide insight into the safety of brodalumab for the treatment of moderate-to-severe plaque psoriasis in adults CONCLUSIONS • These US pharmacovigilance data are consistent with the established safety profile of brodalumab reported in long-term clinical trials and 3-year pharmacovigilance data • No completed suicides occurred throughout the 4-year reporting period, and no new cases of suicide attempts were reported since the 3-year report Funding: 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. Author disclosures: ML is an employee of Mount Sinai; receives research funds from: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB; and is a consultant for Aditum Bio, Almirall, AltruBi, AnaptysBio, Arcutis, Arena Pharmaceuticals, Aristea Therapeutics, Arrive Technologies, Avotres Therapeutics, BiomX, BMS, Boehringer Ingelheim, Brickell Biotech, Cara Therapeutics, Castle Biosciences, Corevitas, Dermavant, Dr. Reddy’s, Evelo Biosciences, Evommune, Facilitation of International Dermatology Education, Forte Biosciences, Foundation for Research and Education in Dermatology, Helsinn Therapeutics, Hexima Ltd., LEO, Meiji Seika Pharma, Mindera, Pfizer, Seanergy, and Verric. AM is a speaker for AbbVie, Amgen, BMS, Eli Lilly, Janssen, and Ortho Dermatologics; and has served as a consultant for BMS, Janssen, Novartis, Ortho Dermatologics, and UCB. GH is or has been an investigator for Athenex, BMS, Boehringer Ingelheim, Bond Avillion, Celgene, Eli Lilly, Novartis, Janssen, MC2, PellePharm, Pfizer, and UCB; and a consultant, advisor, or speaker for AbbVie, Boehringer Ingelheim, Dermtech, Eli Lilly, Incyte, Janssen, LEO, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, SUN, and UCB. AJ is an employee of Ortho Dermatologics (a division of Bausch Health US, LLC). References: 1. Siliq [package insert]. Bausch Health US, LLC; 2017. 2. Lebwohl et al. J Am Acad Dermatol. 2018;78:81-89. 3. Lebwohl et al. Dermatol Ther. 2021;34:e15105. Erratum in Dermatol Ther. 2022;35:e15664. 4. Lebwohl et al. Dermatol Ther (Heidelb). 2021;11:173-180. Previous presentation information: Data included in this poster have been previously presented in full at the Fall Clinical Dermatology Conference; October 20-23, 2022; Virtual and Las Vegas, NV. Presented at Winter Clinical Dermatology Conference - Hawaii ® • January 13-18, 2023 • Kohala Coast, HI Table. US Pharmacovigilance Monitoring of Brodalumab Through 4 Years (August 15, 2017–August 14, 2021) AE Event, n (r)a Event drug related, nb Discontinued, n (%)c Maintained, n (%)c Action unknown/NA, n (%)c Arthralgia 115 (2.52) 1 25 (22) 53 (46) 37 (32) Headache 45 (0.99) 0 6 (13) 25 (56) 14 (31) Fatigue 44 (0.96) 1 6 (14) 20 (45) 18 (41) Injection-site reaction 35 (0.77) 3 1 (3) 18 (51) 16 (46) Diarrhea 33 (0.72) 0 6 (18) 19 (58) 8 (24) Myalgia 31 (0.68) 0 6 (19) 18 (58)d 7 (23) Nausea 29 (0.64) 0 5 (17) 17 (59) 7 (24) Influenza 23 (0.50) 1 9 (39) 7 (30) 7 (30) Oropharyngeal pain 21 (0.46) 0 2 (10) 11 (52)e 8 (38) Neutropenia 1 (0.02) 0 0 1 (100) 0 Tinea infection 0 — — — — AE, adverse event; NA, not applicable; r, exposure-adjusted event rate per 100 patient-years. aNumber of patients experiencing AE, not total number of AEs. bRelatedness to brodalumab was based on company-determined causality. cTreatment action taken upon AE occurrence. Percentage is event divided by total number of patients experiencing event. dOne patient increased brodalumab dose. eOne patient temporarily stopped taking the drug but planned to resume brodalumab treatment. 2.24 1.14 0.81 0.15 0.04 0 0.00 0.50 1.00 1.50 2.00 2.50 Serious infection Depression Malignancies Fungal infection IBD Suicide Ex po su re -a dj us te d ev en t ra te p er 1 00 P Y s