PMID- 34481517 OWN - NLM STAT- MEDLINE DCOM- 20211028 LR - 20240403 IS - 1478-6362 (Electronic) IS - 1478-6354 (Print) IS - 1478-6354 (Linking) VI - 23 IP - 1 DP - 2021 Sep 4 TI - Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. PG - 231 LID - 10.1186/s13075-021-02613-9 [doi] LID - 231 AB - BACKGROUND: To investigate the efficacy of secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) grouped by disease activity as assessed by C-reactive protein (CRP) levels and/or magnetic resonance imaging (MRI) scores, human leukocyte antigen (HLA)-B27 status, and sex. METHODS: The phase III PREVENT study randomized (1:1:1) 555 patients to receive subcutaneous secukinumab 150 mg with (LD) or without (NL) loading dose or placebo weekly, followed by every 4 weeks starting at week 4. Here, we report the results of a post hoc analysis reporting the efficacy outcomes (pooled secukinumab) to 16 weeks by CRP, MRI, HLA-B27, and sex. RESULTS: Efficacy differences between the secukinumab and the placebo groups were highest in the CRP+, MRI+, HLA-B27+, and male subgroups, particularly for Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates in the CRP+/MRI+ subgroup was 52.3% (secukinumab) versus 21.8% (placebo; P < 0.0001) at week 16. ASAS40 response rates (secukinumab versus placebo) were 43.9% versus 32.6% in HLA-B27+, 32.7% versus 16.4% in HLA-B27- subgroups, 51.2% versus 30.8% in male, and 31.7% versus 25.3% in female patients, respectively. CONCLUSIONS: Secukinumab improved the signs and symptoms of nr-axSpA across patients grouped by CRP (+/-) and/or MRI (+/-) status, HLA-B27 (+/-) status, and sex. The highest treatment differences between secukinumab and placebo were observed in patients with both elevated CRP and evidence of sacroiliitis on MRI. Treatment difference was minimal between HLA-B27 (+) and (-) subgroups. Male patients had higher relative responses than female patients. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02696031 . Registered on 02 March 2016. CI - (c) 2021. The Author(s). FAU - Braun, Jurgen AU - Braun J AUID- ORCID: 0000-0002-9156-5095 AD - Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany. juergen.braun@elisabethgruppe.de. FAU - Blanco, Ricardo AU - Blanco R AD - IDIVAL, Hospital University Marques de Valdecilla, Santander, Spain. FAU - Marzo-Ortega, Helena AU - Marzo-Ortega H AD - NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust and LIRMM, University of Leeds, Leeds, UK. FAU - Gensler, Lianne S AU - Gensler LS AD - Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, USA. FAU - van den Bosch, Filip AU - van den Bosch F AD - Department of Internal Medicine and Pediatrics, VIB Center for Inflammation Research, Ghent University, Ghent, Belgium. FAU - Hall, Stephen AU - Hall S AD - Monash University, Melbourne, Australia. FAU - Kameda, Hideto AU - Kameda H AD - Toho University, Tokyo, Japan. FAU - Poddubnyy, Denis AU - Poddubnyy D AD - Charite Universitatsmedizin, Berlin, Germany. FAU - van de Sande, Marleen AU - van de Sande M AD - Department of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute, Amsterdam UMC, AMC/University of Amsterdam, Amsterdam, The Netherlands. AD - Amsterdam Rheumatology and Immunology Centre (ARC), Amsterdam, The Netherlands. FAU - Wiksten, Anna S AU - Wiksten AS AD - Novartis Pharma AG, Basel, Switzerland. FAU - Porter, Brian O AU - Porter BO AD - Novartis Pharmaceuticals Corporation, East Hanover, USA. FAU - Shete, Abhijit AU - Shete A AD - Novartis Pharma AG, Basel, Switzerland. FAU - Richards, Hanno B AU - Richards HB AD - Novartis Pharma AG, Basel, Switzerland. FAU - Haemmerle, Sibylle AU - Haemmerle S AD - Novartis Pharma AG, Basel, Switzerland. FAU - Deodhar, Atul AU - Deodhar A AD - Oregon Health & Science University, Portland, USA. LA - eng SI - ClinicalTrials.gov/NCT02696031 PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20210904 PL - England TA - Arthritis Res Ther JT - Arthritis research & therapy JID - 101154438 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (HLA-B27 Antigen) RN - DLG4EML025 (secukinumab) SB - IM MH - Antibodies, Monoclonal, Humanized MH - Female MH - HLA-B27 Antigen MH - Humans MH - Male MH - *Spondylarthritis/diagnostic imaging/drug therapy MH - *Spondylitis, Ankylosing/diagnostic imaging/drug therapy MH - Treatment Outcome PMC - PMC8418044 OTO - NOTNLM OT - Biologicals OT - C-reactive protein OT - Gender OT - Human leukocyte antigen B27 OT - Interleukins OT - Magnetic resonance imaging OT - Non-radiographic axial spondyloarthritis COIS- JB reports grant/research support from AbbVie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB; consultation fees from AbbVie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB; and speakers bureau fees from AbbVie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB. RB reports research grants from AbbVie, MSD, and Roche; consulting fees from AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD; and speakers bureau fees from AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, MSD, and Eli Lilly. HMO reports grant/research support from Janssen and Novartis; is a consultant for AbbVie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, and UCB; and received speakers' bureau fees from AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB. LSG reports grant/research support from UCB, AbbVie, Amgen, Novartis, and Pfizer and consulting fees from Galapagos, Eli Lilly, Janssen, Novartis, Pfizer, and UCB. FVDB reports research grants, consultancy fees, or speaker honoraria from AbbVie, BMS, Celgene, Galapagos, Janssen, Eli Lilly, Merck, Novartis, Pfizer, and UCB. SH reports consulting or speaking fees from Novartis, Merck, Janssen, Pfizer, Eli Lilly, and UCB and research grants from AbbVie, UCB, Janssen, and Merck. HK reports grant/research support from AbbVie, Asahi-Kasei, Chugai, Eisai, Mitsubishi-Tanabe, and Novartis; consulting fees from AbbVie, Boehringer, Celgene, Eli Lilly, Janssen, Novartis, Sanofi, and UCB; and received speakers' bureau fees from AbbVie, Asahi-Kasei, BMS, Chugai, Eisai, Eli Lilly, Janssen, Mitsubishi-Tanabe, Novartis, and Pfizer. DP reports research grants from AbbVie, Eli Lilly, MSD, Novartis, and Pfizer; consultation fees from AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, UCB, and Celgene; and speaker fees from AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer, UCB, and Roche. MVDS reports grant/research support from Novartis, Eli Lilly, Boehringer Ingelheim, Janssen, and UCB; consultant fees from AbbVie, Novartis, Eli Lily, and MSD; and speaker fees from Novartis and MSD. ASW, BOP, AS, HBS, and SH are employees of Novartis and own Novartis stock. AD reports receiving honoraria for consulting or speaking for or research grants from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, GSK, Janssen, Novartis, Pfizer, and UCB. EDAT- 2021/09/06 06:00 MHDA- 2021/10/29 06:00 PMCR- 2021/09/04 CRDT- 2021/09/05 20:23 PHST- 2021/06/21 00:00 [received] PHST- 2021/08/23 00:00 [accepted] PHST- 2021/09/05 20:23 [entrez] PHST- 2021/09/06 06:00 [pubmed] PHST- 2021/10/29 06:00 [medline] PHST- 2021/09/04 00:00 [pmc-release] AID - 10.1186/s13075-021-02613-9 [pii] AID - 2613 [pii] AID - 10.1186/s13075-021-02613-9 [doi] PST - epublish SO - Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.