Maintenance of Remission After Tocilizumab Withdrawal in Patients With Glucocorticoid‐Dependent Polymyalgia Rheumatica
Year: 2025
Type: article
Abstract: OBJECTIVE: The SEMAPHORE trial evaluated the efficacy and safety of tocilizumab (TCZ) treatment in patients with glucocorticoid (GC)-dependent polymyalgia rheumatica (PMR). TCZ reduced GC dose and disease activity at week 24. This study aimed to assess relapse rates after stopping TCZ treatment in patients achieving remission at week 24. METHODS: In the randomized study, 101 patients received intravenous TCZ (8 mg/kg) or placebo for 24 weeks. Of the 49 patients treated with TCZ, 33 achieved the primary outcome (PMR activity score <10 and GC dose reduction of ≤5 mg/day or ≥10 mg). All 33 patients except one stopped TCZ treatment at week 24 and completed a visit at week 32, with optional follow-up visits every eight weeks until week 48. Relapse was defined as the failure of the primary composite outcome during follow-up or the need for one or more TCZ infusion. Results were analyzed using Kaplan-Meier curves. RESULTS: Among the 33 patients who received TCZ in remission at week 24, seven stopped follow-ups before week 48, and two of the remaining 26 patients (7.7%) sustained remission in the following six months. 24 (92.3%) of the total patients experienced a relapse. The median time to relapse was 15 weeks (interquartile range, 8-25 weeks). CONCLUSION: Among patients with GC-dependent PMR in remission after a six-month TCZ treatment, only a minority of the patients remained relapse-free after TCZ discontinuation. This study suggests that a six-month treatment course is not long enough to withdraw the TCZ. Further studies are needed to determine the optimal TCZ treatment duration and strategies for cessation to prevent relapses.
Source: Arthritis & Rheumatology
DOI: 10.1002/art.43221
Authors: Baptiste Chevet, Aghiles Souki, Emmanuel Nowak, Guillermo Carvajal‐Alegria, Emmanuelle Dernis, Christophe Richez, Marie‐Elise Truchetet, Daniel Wendling, Eric Toussirot, Aleth Perdriger, Jacques‐Eric Gottenberg, Renaud Felten, Bruno Fautrel, Anne Lohse, Laurent Chiche, Pascal Hilliquin, Catherine Le Henaff, Benjamin Dervieux, Guillaume Direz, Isabelle Chary‐Valckenaere, Divi Cornec, Dewi Guellec, Thierry Marhadour, Alain Saraux, Valérie Devauchelle‐Pensec
Institutions: Inserm, Centre Hospitalier Régional Universitaire de Brest, Centre Hospitalier du Mans, Université de Bordeaux, Centre Hospitalier Universitaire de Bordeaux, Centre Hospitalier Universitaire de Besançon, Université de Rennes, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Sorbonne Université, Assistance Publique – Hôpitaux de Paris, Pitié-Salpêtrière Hospital, L'Hôpital Nord Franche-Comté, Hôpital Européen, Centre Hospitalier Sud Francilien, Centre Hospitalier des Pays de Morlaix, Centre Hospitalier de Mulhouse, Centre Hospitalier Régional et Universitaire de Nancy
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,190
OpenAlex ID: W4410216165