Rotation or Change of Biologic After TNF blocker treatment failure for axial Spondyloarthritis

Elisa Dalix¹, Philippe Goupille², Daniel Wendling³, Christian Roux⁴, Jean-Hughes Samon⁵, Olivier Brocq⁶, Anne Tournadre⁷, Arnaud Constantin⁸, Maxime Breban⁹, Gregoire Cormier¹⁰, Tristan Pascart¹¹, Thierry Lequerre¹², Pascal Claudepierre¹³, Eric Lespessailles¹⁴, Benoit Legoff¹⁵, Jeremie Sellam¹⁶, Athan Baillet¹⁷, Thierry Schaeverbeke¹⁸, Stephan Pavy¹⁹, Valerie Devauchelle-Pensec²⁰, Elisabeth Gervais²¹, Laure Gossec²², Corinne Miceli²³, Yves-Marie Pers²⁴, Cedric Lukas²⁵, Renaud Felten²⁶, Beatrice Bouvard²⁷, Amelie Denis²⁸, Emmanuelle Dernis²⁸, Emilie Presles²⁹, Florence Rancon²⁹ and Hubert Marotte³⁰, ¹Université Jean Monnet, CHU Saint-Etienne, Mines Saint-Etienne, INSERM, Saint-Etienne, France, ²Department of Rheumatology and INSERM-CIC¹⁴¹⁵, University Hospital of Tours, EA ⁷⁵⁰¹ GICC, University of Tours, Tours, France, ³Rhumatologie, CHU de Besançon, Besancon, France, ⁴Service de rhumatologie, CHU de Nice, IbV, Université Cote d'Azur, Nice, France, ⁵Service de Rhumatologie, Hôpital Maison Blanche, Centre Hospitalier Universitaire de Reims, Reims, France; Université de Reims Champagne-Ardenne, Faculté de Médicine, EA ³⁷⁹⁷, Reims, France, ⁶Rheumatology Department, CHPG Monaco, Monaco, Monaco, ⁷Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France, ⁸Rheumatology Center, Toulouse University Hospital, Toulouse, France, ⁹INSERM UMR¹¹⁷³, INFLAMEX, Laboratoire d'Excellence, Rheumatology Division, Ambroise Paré Hospital (AP-HP), Paris, France, ¹⁰Rheumatology, Centre Hospitalier Departemental Vendee, La Roche-sur-Yon, France, ¹¹Department of Rheumatology, Université Catholique de Lille Hôpital Saint Philibert, Lomme, France, ¹²Department of Rheumatology & CIC-CRB ¹⁴⁰⁴, Inserm, PANTHER UMR ¹²³⁴, University of Rouen Normandie, Normandie University, CHU Rouen, Rouen, France, ¹³AP-HP, Henri-Mondor Hospital, Department of Rheumatology, EpiDermE, Université Paris Est Créteil, Créteil, France, ¹⁴Translational Medicine Research Platform, PRIMMO, University Hospital Centre of Orleans, Orleans, France, ¹⁵Nantes Université, ONIRIS, Univ Angers, CHU Nantes, INSERM, Regenerative Medicine and Skeleton, RMeS, UMR ¹²²⁹, Nantes, France, ¹⁶Rheumatology Department, Sorbonne Université, Saint-Antoine Hospital Assistance Publique Hôpitaux de Paris (AP-HP), Centre de Recherche Saint-Antoine (CRSA) Inserm UMRS-⁹³⁸,, Paris, France, ¹⁷Université Grenoble Alpes, ⁴UMR⁵⁵²⁵, Grenoble, France, ¹⁸Department of Rheumatology, Hôpital Pellegrin, Bordeaux, France, ¹⁹Department of Rheumatology, Hôpital Bicêtre, Assistance Publique - Hôpitaux de Paris, Le Kremlin-Bicetre, ²⁰Department of Rheumatology, Université de Bretagne Occidentale, CHU Brest, INSERM (U¹²²⁷), LabEx IGO, Brest, France, ²¹LITEC, Université de Poitiers, CHU Poitiers, Poitiers, France, ²²Sorbonne Université, AP-HP & EULAR, Paris, France, ²³Immunoregulation Unit, Institut Pasteur, Cochin AP-HP, Paris, France, ²⁴IRMB, University of Montpellier, Inserm U¹¹⁸³, CHU Montpellier, Montpellier, France, ²⁵Rheumatology department, CHU and University of Montpellier, Montpellier, France; UMR UA¹¹ Inserm (IDESP), University of Montpellier, Montpellier, France, ²⁶Service de Rhumatologie, CHU de Strasbourg - Hôpital de Hautepierre, Strasbourg, France, ²⁷Rhumatologie, Centre Hospitalier Universitaire, Angers, France, ²⁸CH Le Mans, Le Mans, France, ²⁹CHU Saint-Etienne, CIC ¹⁴⁰⁸, Saint-Etienne, France, ³⁰Université Jean Monnet, CHU de Saint-Etienne, CIC ¹⁴⁰⁸, Mines Saint-Etienne, INSERM, SSINBIOSE ¹⁰⁵⁹, Saint-Etienne, France

Meeting: ACR Convergence 2025

Date of first publication: October 13, 2025

Keywords: Biologicals, clinical trial, Late-Breaking 2025, spondyloarthritis

Session Information

Date: Tuesday, October 28, 2025

Title: (LB01–LB18) Late-Breaking Posters

Session Type: Poster Session

Session Time: 10:30AM-12:30PM

Background/Purpose: Axial spondyloarthritis (axSpA) is initially treated with non-steroidal anti-inflammatory drugs. In case of inadequate response, ACR/EULAR recommend biological disease-modifying antirheumatic drugs (bDMARDs). Up to 2015, TNF inhibitors (TNFi) were the only available option. Since then, IL-17A inhibitors (IL-17Ai) have also demonstrated efficacy. The 2022 ASAS-EULAR guidance proposes switching an alternative bDMARD after TNF inhibitors failure without mandating a change of mechanism of action. Therefore, we designed a randomized multicenter clinical trial to identify the most effective treatment after a first TNFi failure in axSpA, comparing an IL-17Ai to a second TNFi.

Methods: The ROC-SpA (Rotation Or Change of biologics after first TNFi treatment failure in axSpA patients) study is a prospective, randomized, multicenter, open-label, superiority, phase IV trial. Patients with active axSpA (BASDAI >4 or ASDAS >3.5), an inadequate 3-month response to a first TNFi, and stable doses of conventional synthetic (cs)DMARDs, oral corticosteroids, and/or NSAIDs for at least one month were enrolled across 31 centers in France and Monaco. Patients were randomized to receive either an IL-17Ai or a second TNFi. The primary outcome was the ASAS40 response at week 24. Secondary outcomes were ASAS 40 at weeks 12 and 52, other clinical assessments (ASAS20, partial remission rate, ASDAS major improvement rate) at weeks 12, 24, and 52. The primary analysis was performed at the end of the study according to the intent-to-treat principle.

Results: Baseline characteristics of the enrolled patients are shown in Table 1. Both drug options led to similar rates of response ASAS40 at week 24 (15.2% for IL-17Ai and 14.5% for TNFi (14.5%), thus the primary outcome assessing the superiority of IL-17Ai was not achieved (Figure 1). No statistically significant difference was observed between groups for other secondary endpoints. ASDAS declined similarly in both groups to 2.6 (1.0) at week 12, 2.5 (0.9) at week 24, and 2.3 (1.0) at the end of follow-up. On-treatment maintenance at week 54 was 62.8% with IL-17Ai and 54.9% with TNFi. No new safety signals were identified, and adverse-event rates were comparable between groups. Exploratory, non-significant trends favored an IL-17Ai after primary nonresponse and in patients with cutaneous psoriasis, HLA-B27 negativity, or CRP < 5 mg/L. Conversely, when the first TNFi was discontinued for an adverse event, cycling to another TNFi appeared more favorable.

Conclusion: In this randomized trial of axSpA patients with inadequate response to a first TNFi, switching to an IL-17Ai was not superior to cycling to a second TNFi for the primary endpoint. These findings directly inform treatment sequencing after TNFi failure and support individualized, shared decision-making in axSpA. They also align with current recommendations that, for the axial symptom control, the choice among available bDMARDs should not be based on anticipated efficacy differences.

Table 1. Main characteristics of the patients at baseline

Figure 1. Clinical responses with adjusted odds ratio in IL-17i and TNFi groups at weeks 12, 24, and 52

Disclosures: E. Dalix: None; P. Goupille: AbbVie/Abbott, 2, 4, 6, Alfasigma, 4, 6, Bristol-Myers Squibb(BMS), 4, 6, Celltrion, 2, 4, 6, Eli Lilly, 2, 4, 6, Janssen, 2, 4, 6, Merck/MSD, 4, 6, Novartis, 4, 6, Pfizer, 4, 6, UCB, 2, 4, 6; D. Wendling: Abbvie, 1, 6, Alfasigma, 6, Biocon, 6, Celltrion, 4, Janssen, 4, Novartis, 4, 6, UCB, 4, 6; C. Roux: None; J. Samon: AbbVie/Abbott, 1, 2, Eli Lilly, 1, 2, Merck/MSD, 2, Novartis, 1, 2, Pfizer, 1, 2, UCB, 1, 2; O. Brocq: None; A. Tournadre: None; A. Constantin: None; M. Breban: Janssen, 1, 5, Novartis, 5, UCB, 1; G. Cormier: None; T. Pascart: None; T. Lequerre: None; P. Claudepierre: abbvie, 6, alphasigma, 6, amgen, 6, BMS, 6, johnson and Johnson, 6, lilly, 6, novartis, 6, Pfizer, 6, ucb, 6; E. Lespessailles: None; B. Legoff: None; J. Sellam: None; A. Baillet: None; T. Schaeverbeke: None; S. Pavy: None; V. Devauchelle-Pensec: AbbVie/Abbott, 2, Novartis, AbbVie, Lilly, Fresenius Kabi, 6; E. Gervais: None; L. Gossec: AbbVie, 2, 5, Alfasigma, 2, Amgen, 2, Bristol-Myers Squibb(BMS), 2, Celltrion, 2, Johnson & Johnson, 2, Lilly, 2, 5, MoonLake, 2, Novartis, 2, 5, Pfizer, 2, STADA, 2, UCB, 2, 5; C. Miceli: None; Y. Pers: None; C. Lukas: None; R. Felten: AbbVie/Abbott, 2, 4, Eli Lilly, 2, Novartis, 2, 3, 4, UCB, 2, 4; B. Bouvard: None; A. Denis: None; E. Dernis: None; E. Presles: None; F. Rancon: None; H. Marotte: None.

To cite this abstract in AMA style:

Dalix E, Goupille P, Wendling D, Roux C, Samon J, Brocq O, Tournadre A, Constantin A, Breban M, Cormier G, Pascart T, Lequerre T, Claudepierre P, Lespessailles E, Legoff B, Sellam J, Baillet A, Schaeverbeke T, Pavy S, Devauchelle-Pensec V, Gervais E, Gossec L, Miceli C, Pers Y, Lukas C, Felten R, Bouvard B, Denis A, Dernis E, Presles E, Rancon F, Marotte H. Rotation or Change of Biologic After TNF blocker treatment failure for axial Spondyloarthritis [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/rotation-or-change-of-biologic-after-tnf-blocker-treatment-failure-for-axial-spondyloarthritis/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/rotation-or-change-of-biologic-after-tnf-blocker-treatment-failure-for-axial-spondyloarthritis/