D Thaci1, S Piaserico2, R B Warren3, A K Gupta4,5, W Cantrell6, Z Draelos7, P Foley8, A Igarashi9, R G Langley10, A Asahina11, M Young12, M Falqués13, I Pau-Charles13, A M Mendelsohn14, S J Rozzo14, K Reich15. 1. Institute and Comprehensive Centre for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, Lübeck, 23538, Germany. 2. Dermatology Unit, Department of Medicine, University of Padua, Via Vincenzo Gallucci 4, 35128, Padua, Italy. 3. The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, M6 8HD, UK. 4. Division of Dermatology, Department of Medicine, University of Toronto School of Medicine, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, ON, M5G 2C4, Canada. 5. Mediprobe Research Inc, 645 Windermere Road, London, ON, N5X 2P1, Canada. 6. Village Dermatology, 2900 Cahaba Road, Birmingham, AL, 35223, USA. 7. Dermatology Consulting Services, 2444 North Main Street, High Point, NC, 27262, USA. 8. Skin Health Institute Inc., Level 1, 80 Drummond Street, Carlton, Victoria, 3053, Australia. 9. NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan. 10. Division of Dermatology, Department of Medicine, Dalhousie University, 6054 Coburg Road, Halifax, NS, B3H 1Z2, Canada. 11. Department of Dermatology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. 12. Mindful Dermatology, Modern Research Associates, 9101 N Central Expy Ste 160, Dallas, TX, 75231, USA. 13. Almirall R&D, Carrer de Laureà Miró, 408, 410, 08980, Sant Feliu de Llobregat, Barcelona, Spain. 14. Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ, 08540, USA. 15. Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, M, Hamburg, 20246, Germany.
Abstract
BACKGROUND: The phase III reSURFACE 1 and reSURFACE 2 (NCT01722331/NCT01729754) trials of the anti-interleukin-23p19 monoclonal antibody tildrakizumab (TIL) for psoriasis treatment are complete. OBJECTIVES: We present 5-year pooled data from reSURFACE 1 and reSURFACE 2. METHODS: reSURFACE 1 and reSURFACE 2 were double-blind, randomized, controlled studies with optional long-term extensions. Adults with moderate-to-severe chronic plaque psoriasis were randomized 2 : 2 : 1 to TIL 100 mg (TIL 100) or 200 mg (TIL 200) or placebo at weeks 0 and 4, and every 12 weeks thereafter [reSURFACE 2 included an etanercept (ETN) arm]. Efficacy outcomes included proportions of patients achieving absolute and relative improvement from baseline Psoriasis Area and Severity Index (PASI) score through week 244 in TIL responders (≥ 75% improvement from baseline PASI; PASI 75 response) continuously receiving the same dose and ETN partial responders and nonresponders (PASI < 75 response) switched to TIL 200 at week 28. Safety was assessed from adverse events (AEs) in all patients as treated. RESULTS: Efficacy analyses included 329 and 227 week 28 responders to TIL 100 and TIL 200, respectively, and 121 ETN partial responders/nonresponders switched to TIL 200 at week 28. Of TIL 100 or TIL 200 responders and ETN partial responders/nonresponders entering the extensions, 235/302, 176/213 and 85/107, respectively, were evaluated at week 244, and 88·7%, 92·5% and 81·3%, respectively, achieved PASI 75 response. Exposure-adjusted rates of serious AEs were 6·3 and 6·0 patients with events per 100 patient-years of TIL 100 and TIL 200, respectively. CONCLUSIONS: TIL treatment provided sustained disease control over 5 years in week 28 TIL responders and ETN partial responders/nonresponders, with a reassuring safety profile.
RCT Entities:
BACKGROUND: The phase III reSURFACE 1 and reSURFACE 2 (NCT01722331/NCT01729754) trials of the anti-interleukin-23p19 monoclonal antibody tildrakizumab (TIL) for psoriasis treatment are complete. OBJECTIVES: We present 5-year pooled data from reSURFACE 1 and reSURFACE 2. METHODS: reSURFACE 1 and reSURFACE 2 were double-blind, randomized, controlled studies with optional long-term extensions. Adults with moderate-to-severe chronic plaque psoriasis were randomized 2 : 2 : 1 to TIL 100 mg (TIL 100) or 200 mg (TIL 200) or placebo at weeks 0 and 4, and every 12 weeks thereafter [reSURFACE 2 included an etanercept (ETN) arm]. Efficacy outcomes included proportions of patients achieving absolute and relative improvement from baseline Psoriasis Area and Severity Index (PASI) score through week 244 in TIL responders (≥ 75% improvement from baseline PASI; PASI 75 response) continuously receiving the same dose and ETN partial responders and nonresponders (PASI < 75 response) switched to TIL 200 at week 28. Safety was assessed from adverse events (AEs) in all patients as treated. RESULTS: Efficacy analyses included 329 and 227 week 28 responders to TIL 100 and TIL 200, respectively, and 121 ETN partial responders/nonresponders switched to TIL 200 at week 28. Of TIL 100 or TIL 200 responders and ETN partial responders/nonresponders entering the extensions, 235/302, 176/213 and 85/107, respectively, were evaluated at week 244, and 88·7%, 92·5% and 81·3%, respectively, achieved PASI 75 response. Exposure-adjusted rates of serious AEs were 6·3 and 6·0 patients with events per 100 patient-years of TIL 100 and TIL 200, respectively. CONCLUSIONS: TIL treatment provided sustained disease control over 5 years in week 28 TIL responders and ETN partial responders/nonresponders, with a reassuring safety profile.
Authors: A P Fernandez; E Dauden; S Gerdes; M G Lebwohl; M A Menter; C L Leonardi; M Gooderham; K Gebauer; Y Tada; J P Lacour; L Bianchi; A Egeberg; I Pau-Charles; A M Mendelsohn; S J Rozzo; N N Mehta Journal: J Eur Acad Dermatol Venereol Date: 2022-06-25 Impact factor: 9.228