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POS0797 (2024)
REAL-WORLD EFFECTIVENESS OF IL-17A INHIBITORS IN EUROPEAN PATIENTS WITH AXIAL SPONDYLOARTHRITIS – IMPACT OF PREVIOUS TNF-INHIBITOR EXPOSURE
Keywords: Epidemiology, Biological DMARD, Real-world evidence
M. Pons1, S. Georgiadis1, M. Lund Hetland1,2, L. Linde1, M. Shoae Kazemi1, S. Horskjær Rasmussen1, A. G. Loft3,4, B. Michelsen1,5,6, D. DI Giuseppe7, G. J. Macfarlane8, G. T. Jones8, K. Laas9, S. Vorobjov10, I. Castrejon11,12, F. Sánchez-Alonso13, Z. Rotar14,15, K. Perdan Pirkmajer14,15, J. Baranová16, B. Glintborg1,2,17, A. Ciurea18, M. Bernardes19,20, P. Valente21, B. Gudbjornsson22,23, G. Grondal23,24, C. Codreanu25, C. Mogosan25, S. Aarrestad Provan6,26, F. Iannone27, R. F. Caporali28, J. K. Wallman29, V. Rantalaiho30,31, R. Peltomaa32, G. Bakland33,34, L. Šenolt35, M. Østergaard1,2, L. Midtbøll Ørnbjerg1, On Behalf of The European Spondyloarthritis Research Collaboration Network
1Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre for Head and Orthopedics, Rigshospitalet, Glostrup, Denmark
2Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
3Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark
4Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
5Research Unit, Sørlandet Hospital, Kristiansand, Norway
6Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway
7Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden
8Aberdeen Centre for Arthritis and Musculoskeletal Health (Epidemiology Group), University of Aberdeen, Aberdeen, United Kingdom
9Department of Rheumatology, East-Tallinn Central Hospital, Tallinn, Estonia
10National Institute for Health Development, Tallinn, Estonia
11Department of Rheumatology, Hospital General, Universitario Gregorio Marañón, Madrid, Spain
12Faculty of Medicine, Complutense, University of Madrid, Madrid, Spain
13Research Unit, Spanish Society of Rheumatology, Madrid, Spain
14Department of Rheumatology, University Medical Centre Ljubljana, Ljubljana, Slovenia
15Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
16Institute of Biostatistics and Analyses, Ltd, Brno, Czech Republic
17DANBIO registry, Rigshospitalet, Glostrup, Denmark
18Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
19Department of Medicine, Faculty of Medicine, University of Porto, Porto, Portugal
20Rheumatology Department, Centro Hospitalar e Universitário de São João, Porto, Portugal
21Rheumatology Department, Hospital de São Sebastião, Centro Hospitalar de Entre o Douro e Vouga,, Santa Maria da Feira, Portugal
22Centre for Rheumatology Research, Landspitali University Hospital, Reykjavik, Iceland
23Faculty of Medicine, University of Iceland, Reykjavik, Iceland
24Department for Rheumatology, Landspitali University Hospital, Reykjavik, Iceland
25Center for Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania
26Public Health Section, Inland Norway University of Applied Sciences, Elverum, Norway
27Rheumatology Unit, DiMePReJ, University of Bari, Bari, Italy
28Department of Rheumatology and Medical Sciences, ASST G. Pini-CTO, Milan and University of Milan, Milan, Italy
29Department of Clinical Sciences Lund, Rheumatology, Skåne University Hospital, Lund University, Lund, Sweden
30Tampere University Hospital, Centre for Rheumatic Diseases, Tampere, Finland
31Tampere University, Faculty of Medicine and Health Technology, Tampere, Finland
32Department of Rheumatology, Inflammation Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
33Department of Rheumatology, University Hospital North Norway, Tromsø, Norway
34Institute of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway
35Institute of Rheumatology and Department of Rheumatology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic

Background: Interleukin-17A inhibitors (IL-17Ai) and tumour necrosis factor inhibitors (TNFi) are available for treatment of axial spondyloarthritis (axSpA). Bio-naïve patients generally respond better to the first TNFi compared to those who are TNFi-experienced. However, real-world data on the effectiveness of IL-17Ai used as a first line treatment vs a second or third line treatment, i.e. after TNFi exposure, are sparse.


Objectives: In axSpA patients initiating a first IL-17Ai treatment in routine care and stratified by prior exposure to TNFi (0/1/2), we aimed to a) describe the baseline demographics, clinical and disease activity characteristics, b) assess and compare 6-month composite scores of low disease activity (LDA) and response rates, and c) assess and compare 12-month retention rates.


Methods: The study was conducted within the European Spondyloarthritis (EuroSpA) Research Collaboration Network. Patients with axSpA who initiated a first IL-17Ai between 2018 and 2022 were included from 13 European registries. Logistic regression analyses were employed to compare 6-month LDA (Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) <2.1 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <4) and response rates (ASAS 40 response and ASDAS-CRP Clinically Important Improvement (CII), i.e delta-ASDAS-CRP ≥1.1). Log-rank tests and cox regression analyses were performed to compare 12-month IL-17Ai retention. All analyses were adjusted for age, sex, registry, time since diagnosis, and ASDAS-CRP at treatment start (baseline). To account for missing baseline data, multivariate imputation by chained equations were employed.


Results: A total of 2265 axSpA patients were included, with 799/787/679 having previously received 0/1/2 TNFi, respectively. At baseline, bio-naïve patients were more likely to be male (64% / 53%/49% for 0/1/2 previously TNFi-exposed) and HLA-B27 positive (81%/78%/74%). Additionally, bio-naïve patients had higher disease activity according to BASDAI (6.4/5.2/5.8) and ASDAS-CRP (4.2/3.3/3.5), and a higher proportion of them received concomitant csDMARDs (29%/21%/19%).

At 6 months, bio-naïve patients demonstrated numerically higher rates of LDA and response across all outcomes compared to TNFi-experienced patients. Similarly, after adjusting for confounders, significantly better responses were found for bio-naïve compared to TNFi-experienced patients for all outcomes (Table 1).

The overall 12-month IL-17Ai retention rate was 79.5%. Notably, the 12-month IL-17Ai retention decreased with an increased number of previous TNFi (85.2%/77.9%/74.6%, for 0/1/2 previously TNFi-exposed, p<0.001), with statistically significant differences between bio-naïve and TNFi-experienced patients (Table 1).


Conclusion: This large real-world study showed overall high one-year retention of IL-17Ai treatment in axSpA. Notably, bio-naïve patients, despite exhibiting higher baseline disease activity, demonstrated superior 6-month LDA and response rates as well as higher 12-month retention compared to TNFi-experienced patients.

6-month LDA and response rates, and 12-month retention for axSpA patients initiating a first IL-17Ai, stratified by prior exposure to TNFi

Number of previous TNFi 6-month LDA and response rates 12-month retention rates
ASDAS-CRP LDA BASDAI LDA ASAS 40 response ASDAS-CRP CII
Value Fully adjusted OR [95% CI] Value Fully adjusted OR [95% CI] Value Fully adjusted OR [95% CI] Value Fully adjusted OR [95% CI] Retention [95% CI] Fully adjusted HR [95% CI]
TNFi naïve (n= 799) 250/459 (54%) reference 394/530 (74%) reference 105/215 (49%) reference 326/414 (79%) reference 85.2% (82.7-87.8) reference
1 prior TNFi (n=787) 132/378 (35%) 0.40 [0.29-0.57], p<0.001 258/463 (56%) 0.55 [0.40-0.76], p<0.001 60/238 (25%) 0.61 [0.39-0.96], p=0.03 109/309 (35%) 0.28 [0.19-0.42], p<0.001 77.9% (74.8-81.1) 1.86 [1.36-2.24], p<0.001
2 prior TNFi (n=679) 94/356 (26%) 0.35 [0.24-0.51], p<0.001 176/400 (44%) 0.45 [0.32-0.63], p<0.001 46/233 (20%) 0.52 [0.31-0.86], p=0.01 98/280 (35%) 0.30 [0.19-0.48], p<0.001 74.6% (71.1-78.2) 1.97 [1.47-2.63], p<0.001

Acknowledgements: The EuroSpA collaboration is supported by Novartis and UCB. This EuroSpA study was financially supported by UCB. UCB had no influence on the data collection, statistical analyses, abstract preparation, or decision to submit.


Disclosure of Interests: Marion Pons Novartis (paid to the employer), Stylianos Georgiadis Novartis (paid to the employer), Merete Lund Hetland Pfizer, Medac, Sandoz (no personal income, institution), Advisory Board Abbvie (No personal income, paid to institution). Prev. chaired the steering committee of the Danish Rheumatology Quality Registry (DANBIO, DRQ), which receives public funding from the hospital owners and funding from pharmaceutical companies., Research grants (institution) from Abbvie, Biogen, BMS, Celltrion, Eli Lilly, Janssen Biologics B.V, Lundbeck Fonden, MSD, Medac, Pfizer, Roche, Samsung Biopies, Sandoz, Novartis, Nordforsk, Louise Linde Research grant from Novartis, Mehrdad Shoae Kazemi Novartis (paid to the employer), Simon Horskjær Rasmussen Novartis (paid to the employer), Anne Gitte Loft Speaking fees from AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Consulting fees from AbbVie, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Research grant from Novartis, Brigitte Michelsen Consulting fees from Novartis, Research grant from Novartis (paid to employer). Centre for treatment of Rheumatic and Musculoskeletal Diseases (REMEDY) is funded as a Centre for Clinical Treatment Research by The Research Council of Norway (project 328657), Daniela Di Giuseppe: None declared, Gary J. Macfarlane Research grant from GSK, Gareth T. Jones Speaker fee from Janssen., Research grants (paid to employer) from AbbVie, Pfizer, UCB, Amgen, GSK., Karin Laas Abbvie, Johnson and Johnson, Novartis, Pfizer, Sigrid Vorobjov: None declared, Isabel Castrejon Speaker fees from BMS, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer, GSK, Consultancy fees from BMS, Eli-Lilly, Galapagos, Gilead, Janssen, Novartis, MSD, Pfizer, GSK, Fernando Sánchez-Alonso: None declared, Ziga Rotar Abbvie, Amgen, Novartis, MSD, Medis, Biogen, Eli Lilly, Pfizer, Sanofi, Lek, Janssen, Abbvie, Novartis, Eli Lilly, Pfizer, Janssen, SOBI, Swixx BioPharma, AstraZeneca, Katja Perdan Pirkmajer Abbvie, Novartis, MSD, Medis, Eli Lilly, Pfizer, Lek, Janssen, Abbvie, Novartis, Medis, Eli Lilly, Pfize, Boehringer Ingelheim, Jana Baranová: None declared, Bente Glintborg Research grants from Pfizer, Abbvie, BMS, Sandoz, Adrian Ciurea: None declared, Miguel Bernardes: None declared, Paula Valente: None declared, Bjorn Gudbjornsson Speaking fees from Novartis and Nordic-Pharma, Consulting fees from Novartis, Gerdur Grondal: None declared, Catalin Codreanu Speaker fees from AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Corina Mogosan Speaker fees from AbbVie, Boehringer Ingelheim, Ewopharma, Lilly, Novartis, Pfizer, Sella Aarrestad Provan Boehringer Ingelheim, Boehringer Ingelheim, Florenzo Iannone Speaking fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Consulting fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Research grant from BMS, Galapagos, Pfizer, Roberto F. Caporali Speaking fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Consulting fees from Abbvie, Amgen, AstraZeneca, BMS, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, UCB, Johan K Wallman Speaker fees from AbbVie, Amgen, Research support from AbbVie, Amgen, Eli Lilly, Novartis, Pfizer, Vappu Rantalaiho Novartis, Viatris, Pfizer, Ritva Peltomaa Abbvie, Boehringer,Celltrion,Fresenius, Lilly, UCB, Gunnstein Bakland: None declared, Ladislav Šenolt: None declared, Mikkel Østergaard Speaker and/or consultancy fees from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, UCB, Speaker and/or consultancy fees from Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, UCB, Research grants from Abbvie, BMS, Merck, Novartis and UCB, Lykke Midtbøll Ørnbjerg Research grant from Novartis.


DOI: 10.1136/annrheumdis-2024-eular.568
Keywords: Epidemiology, Biological DMARD, Real-world evidence
Citation: , volume 83, supplement 1, year 2024, page 900
Session: Spondyloarthritis (Poster View)