SYNOPSIS • Psoriasis is a chronic inflammatory skin disease that negatively impacts quality of life, leading to significant physical and emotional burden1 • Brodalumab is a fully human interleukin-17 receptor A antagonist approved for the treatment of moderate-to-severe plaque psoriasis in adult patients with inadequate response or loss of response to other systemic therapies2 • Treatment interruption is a common real-world experience in individuals with psoriasis3 METHODS • In a double-blind, placebo-controlled study (NCT01708590; AMAGINE-1),4 patients with moderate-to-severe psoriasis were randomized to brodalumab 210 mg or placebo every 2 weeks (Q2W) • At week 12, patients receiving brodalumab who achieved a static physician’s global assessment (sPGA) of 0 or 1 were rerandomized to their induction dose of brodalumab or placebo • Beginning at week 16, all rerandomized patients who experienced return of disease (sPGA ≥3) qualified for retreatment and received an induction dose of brodalumab • Efficacy was assessed by observed psoriasis area and severity index (PASI) response • Health-related quality of life was evaluated with the dermatology life quality index (DLQI) in the retreatment group (N=79) using nonresponder imputation (NRI), stratified by disease response to previous biologic treatment before entering the study (prior biologic failure [n=18]; prior biologic nonfailure [n=61]) RESULTS Efficacy • A total of 79 patients randomized to brodalumab 210 mg Q2W in the induction phase and rerandomized to placebo in the withdrawal phase experienced return of disease (retreatment group) • Most patients with psoriasis who experienced a return of disease after brodalumab withdrawal returned to their previous levels of PASI response after 24 weeks of retreatment with brodalumab (Figure 1) Health-related quality of life • Mean (SE) DLQI scores in patients in the brodalumab retreatment population at baseline (prior biologic failure, 14.1 [1.9]; prior biologic nonfailure, 12.9 [0.8]) improved at week 52 (prior biologic failure, 1.9 [1.1]; prior biologic nonfailure, 1.8 [0.4]), similar to DLQI scores achieved during the induction phase at week 12 (Figure 2A) – Change in DLQI from baseline to week 52 for the prior biologic failure and nonfailure subgroups were -11.5 (95% CI, -15.6 to -7.4) and -11.0 (95% CI, -12.8 to -9.2), respectively (Figure 2B) – No significant differences in DLQI were observed by prior biologic response through week 52 (P>0.05 between subgroups) Figure 1. PASI 75, PASI 90, and PASI 100 rates after 24 weeks of retreatment with brodalumab 210 mg Q2W in patients randomized to brodalumab 210 mg Q2W in the induction phase and rerandomized to placebo in the withdrawal phase. Observed data analysis. N1, number of patients who entered retreatment phase and had a valid measurement value at the specified week while in the retreatment phase; PASI 75, 90, and 100, psoriasis area and severity index 75%, 90%, and 100% improvement; Q2W, every 2 weeks. Figure 2. (A) Mean total DLQI and (B) change in DLQI from baseline to week 52 for patients in the brodalumab retreatment group by response to prior biologic treatment. Error bars are (A) SE and (B) 95% CI. Nonresponder imputation. DLQI, dermatology life quality index. Retreatment With Brodalumab Results in Skin Clearance and Improvements in Quality of Life in Patients With Psoriasis After Treatment Interruption April Armstrong,1 Brian Keegan,2 George Han,3 Abby Jacobson4 1University of Southern California, Los Angeles, CA; 2Princeton Dermatology Associates, Monroe, NJ; 3Department of Dermatology at Mount Sinai Beth Israel, New York, NY; 4Ortho Dermatologics (a division of Bausch Health US, LLC), Bridgewater, NJ OBJECTIVE • To present efficacy and health-related quality of life data after brodalumab withdrawal and retreatment CONCLUSIONS • Reinitiation with brodalumab after treatment withdrawal led to robust levels of skin clearance recapture; patients returned to their previous levels of responses by 24 weeks • Improvement in quality of life was maintained after retreatment with brodalumab, regardless of exposure to prior biologic treatment • These results are relevant to real-life practice given that it is relatively common for patients to stop and restart their medications because of various factors 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: AA reports serving as a research investigator and/or scientific advisor for AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, EPI, Incyte, Janssen, LEO Pharma, Novartis, Ortho Dermatologics, Pfizer, Sanofi, SUN Pharmaceutical, Regeneron, and UCB. BK reports serving as an investigator, advisory board member, and/or speaker for Valeant Pharmaceuticals North America LLC (currently Bausch Health US, LLC). GH reports serving as an investigator, consultant, advisor, and/or speaker for AbbVie, Athenex, Boehringer Ingelheim, Bond Avillion, Bristol Myers Squibb, Celgene, Dermtech, Eli Lilly, Genzyme, Incyte, Janssen, LEO Pharma, MC2, Novartis, Ortho Dermatologics, PellePharm, Pfizer, Regeneron, Sanofi, SUN Pharmaceutical, and UCB. AJ is an employee of Ortho Dermatologics (a division of Bausch Health US, LLC). Previous presentation information: Data included in this poster have been previously presented in part at the 44th Annual Hawaii Dermatology Seminar®; February 16-21, 2020; Maui, HI. References: 1. Aldredge and Higham. J Dermatolog Nurses Assoc. 2018;10:189-197. 2. Siliq [package insert]. Bausch Health US, LLC; 2017. 3. Lebwohl et al. J Drugs Dermatol. 2020;19:384-387. 4. Papp et al. Br J Dermatol. 2016;175:273-286. Presented at Fall Clinical Dermatology Conference • October 21-24, 2021 • Las Vegas, NV, and Virtual Sponsored by Ortho Dermatologics, a division of Bausch Health US, LLC. INTERNAL USE ONLY. NOT TO BE COPIED OR USED IN SALES PRESENTATIONS. ORTHO DERMATOLOGICS PROPRIETARY AND CONFIDENTIAL 1 1 Figure 1 100 100 100 0 20 40 60 80 100 Week 24 97 97 100 0 20 40 60 80 100 Week 24 84 90 95 0 20 40 60 80 100 Week 24 Of the patients who achieved PASI 75, PASI 90, and PASI 100 before brodalumab withdrawal, 100%, 97%, and 95%, respectively, reached their prior score after 24 weeks of retreatment with brodalumab Patients who achieved PASI 75 at week 12 Patients who achieved PASI 90 at week 12 Patients who achieved PASI 100 at week 12 PASI 75 PASI 90 PASI 100 N1 = Pa tie nt s w ho re ca pt ur ed P A SI 7 5, % Pa tie nt s w ho re ca pt ur ed P A SI 9 0, % Pa tie nt s w ho re ca pt ur ed P A SI 1 00 , % 32 30 21 N1 = 32 30 21 N1 = 32 30 21 INTERNAL USE ONLY. NOT TO BE COPIED OR USED IN SALES PRESENTATIONS. ORTHO DERMATOLOGICS PROPRIETARY AND CONFIDENTIAL 2 Figure 2 14.1 1.9 1.9 12.9 1.7 1.8 0 5 10 15 20 Baseline Week 12 Week 52 M ea n to ta l D LQ I s co re Mean total DLQI Biologic failure Biologic nonfailure -11.5 -11.0 -20 -15 -10 -5 0 Biologic failure Biologic nonfailure DL Q I c ha ng e fr om b as el in e Change in DLQI from baseline to week 52 A B