PMID- 33544883 OWN - NLM STAT- MEDLINE DCOM- 20210920 LR - 20210920 IS - 1365-2133 (Electronic) IS - 0007-0963 (Linking) VI - 185 IP - 2 DP - 2021 Aug TI - Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). PG - 323-334 LID - 10.1111/bjd.19866 [doi] AB - 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. CI - (c) 2021 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists. FAU - Thaci, D AU - Thaci D AD - Institute and Comprehensive Centre for Inflammation Medicine, University of Lubeck, Ratzeburger Allee 160, Lubeck, 23538, Germany. FAU - Piaserico, S AU - Piaserico S AUID- ORCID: 0000-0002-1091-4733 AD - Dermatology Unit, Department of Medicine, University of Padua, Via Vincenzo Gallucci 4, Padua, 35128, Italy. FAU - Warren, R B AU - Warren RB AD - The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, M6 8HD, UK. FAU - Gupta, A K AU - Gupta AK AUID- ORCID: 0000-0002-8664-7723 AD - 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. AD - Mediprobe Research Inc, 645 Windermere Road, London, ON, N5X 2P1, Canada. FAU - Cantrell, W AU - Cantrell W AD - Village Dermatology, 2900 Cahaba Road, Birmingham, AL, 35223, USA. FAU - Draelos, Z AU - Draelos Z AD - Dermatology Consulting Services, 2444 North Main Street, High Point, NC, 27262, USA. FAU - Foley, P AU - Foley P AD - Skin Health Institute Inc., Level 1, 80 Drummond Street, Carlton, Victoria, 3053, Australia. FAU - Igarashi, A AU - Igarashi A AD - NTT Medical Center Tokyo, 5-9-22 Higashi-Gotanda, Shinagawa-ku, Tokyo, 141-8625, Japan. FAU - Langley, R G AU - Langley RG AD - Division of Dermatology, Department of Medicine, Dalhousie University, 6054 Coburg Road, Halifax, NS, B3H 1Z2, Canada. FAU - Asahina, A AU - Asahina A AD - Department of Dermatology, The Jikei University School of Medicine, 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan. FAU - Young, M AU - Young M AD - Mindful Dermatology, Modern Research Associates, 9101 N Central Expy Ste 160, Dallas, TX, 75231, USA. FAU - Falques, M AU - Falques M AD - Almirall R&D, Carrer de Laurea Miro, 408, 410, Sant Feliu de Llobregat, Barcelona, 08980, Spain. FAU - Pau-Charles, I AU - Pau-Charles I AD - Almirall R&D, Carrer de Laurea Miro, 408, 410, Sant Feliu de Llobregat, Barcelona, 08980, Spain. FAU - Mendelsohn, A M AU - Mendelsohn AM AD - Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ, 08540, USA. FAU - Rozzo, S J AU - Rozzo SJ AD - Sun Pharmaceutical Industries, Inc., 2 Independence Way, Princeton, NJ, 08540, USA. FAU - Reich, K AU - Reich K AUID- ORCID: 0000-0001-5248-4332 AD - Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, M, Hamburg, 20246, Germany. LA - eng SI - ClinicalTrials.gov/NCT01729754 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210504 PL - England TA - Br J Dermatol JT - The British journal of dermatology JID - 0004041 RN - 0 (Antibodies, Monoclonal, Humanized) RN - DEW6X41BEK (tildrakizumab) SB - IM CIN - Br J Dermatol. 2021 Aug;185(2):242-243. PMID: 34031870 MH - Adult MH - *Antibodies, Monoclonal, Humanized MH - Humans MH - *Psoriasis/drug therapy MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2021/02/06 06:00 MHDA- 2021/09/21 06:00 CRDT- 2021/02/05 17:12 PHST- 2021/02/04 00:00 [accepted] PHST- 2021/02/06 06:00 [pubmed] PHST- 2021/09/21 06:00 [medline] PHST- 2021/02/05 17:12 [entrez] AID - 10.1111/bjd.19866 [doi] PST - ppublish SO - Br J Dermatol. 2021 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4.