Assessment of the Remission Maintenance After Tocilizumab Withdrawal in Polymyalgia Rheumatica Patients Receiving a 6-month Treatment

Baptiste Chevet¹, Aghiles Souki², nowak emmanuel², Guillermo CARVAJAL ALEGRIA³, Emmanuelle Dernis⁴, Christophe Richez⁵, Marie-Elise Truchetet⁶, DANIEL WENDLING⁷, ERIC TOUSSIROT⁸, aleth Perdriger⁹, Jacques-Eric Gottenberg¹⁰, Renaud FELTEN¹¹, Bruno Fautrel¹², laurent chiche¹³, Anne Walliser-Lohse¹⁴, Pascal Hilliquin¹⁵, Catherine Le Henaff¹⁶, Benjamin Dervieux¹⁷, Guillaume Direz¹⁸, Isabelle Valckenaere¹⁹, Divi Cornec²⁰, Dewi Guellec²¹, Thierry Marhadou²², Alain SARAUX²³ and Valerie Devauchelle²⁴, ¹University Hospital of Brest, Brest, France, ²Centre Hospitalier Regional Universitaire (CHU) de Brest, Brest, France, ³CHRU de Tours, Tours, France, ⁴CH LE MANS, LE MANS, Pays de la Loire, France, ⁵Université de Bordeaux, Bordeaux, France, ⁶Bordeaux University Hospital, Bordeaux, France, ⁷University Hospital, Besançon, France, ⁸university hospital of BESANCON, besancon, France, ⁹Rennes University, Rennes, France, ¹⁰Rheumatology Department, Strasbourg University Hospital,, Strasbourg, France, ¹¹Hopitaux Universitaires de Strasbourg, STRASBOURG, France, ¹²INSERM, UMRS 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique, and Sorbonne University – Assistance Publique-Hôpitaux de Paris, Département de Rhumatologie, Hôpital Pitié-Salpêtrière, Paris, Ile-de-France, France, ¹³hopital europeen, marseille, France, ¹⁴Hopital Nord Franche-Comté, BELFORT, France, ¹⁵Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France, ¹⁶Hopital de Morlaix, Morlaix, France, ¹⁷CH de Mulhouse - Competence center for autoimmune diseases, Internal Medicine, Mulhouse, France, ¹⁸Hôpital du Mans, Le Mans, France, ¹⁹CHU de Nancy, Nancy, France, ²⁰Service de Rhumatologie, CHU de Brest, Brest, France, ²¹CHU de Brest, Brest, France, ²²CHU Cavale Blanche, Brest, France, ²³CHU Brest, Brest, France, ²⁴UBO, Brest, France

Meeting: ACR Convergence 2024

Keywords: Biologicals, Disease Activity, Disease-Modifying Antirheumatic Drugs (Dmards), geriatrics, Polymyalgia Rheumatica (PMR)

Session Information

Date: Sunday, November 17, 2024

Title: Abstracts: Vasculitis – Non-ANCA-Associated & Related Disorders I: Clinical Trials

Session Type: Abstract Session

Session Time: 1:00PM-2:30PM

Background/Purpose: The SEMAPHORE trial¹ was a randomized controlled prospective study to assess the safety and efficacy (success defined by PMR-AS≤10 and GC≤5mg or GC decrease ≥10mg/day) of intra venous (i.v.) tocilizumab (TCZ) in glucocorticoids (GC)-dependent polymyalgia rheumatica (PMR). Tocilizumab was shown to reduce GC while improving clinical and biological inflammatory parameters at 24 weeks. After the 24-week study, patients entered a double-blind extension.

Objectives

In this study, we aimed to assess after the 24^th week the relapse rate and markers of patients who received a 6-month TCZ treatment and achieved remission.

Methods:

Among 101 patients randomly 1:1 allocated to receive i.v. 8mg/kg TCZ or placebo for 24 weeks in the SEMAPHORE trial, 49 received TCZ and 33 of them succeed . All 33 patients but one stopped TCZ at week 24 and they visited at week 32, with optional follow-up visits every 8 weeks until week 48. The relapse was defined by the failure of the primary composite outcome (PMR-activity score ≤10 while glucocorticoids decreased ≤5mg/day or glucocorticoids decrease was ≥10mg/day compared to inclusion) during follow-up or the need for ≥1 TCZ infusion. Results are presented by proportion of patients achieving success at each visit and the outcome over time using a Kaplan Meier curve.

Results: Among the 33 TCZ group patients in remission at week 24, 7 stopped follow-up before the 48^th week, 5 of the other 26 subjects (19.2%) sustained remission in the 6 following months, 21 (80.8%) relapsed. Median time to relapse was 15 weeks (interquartile range: 8-25).

15 patients were considered in relapse because of PMR-AS≥10, 4 for isolated CRP elevation, 2 after the clinician’s decision.

Among the 16 patients treated with TCZ but not in remission at 24^th week, 4 of them (25%) achieved the primary outcome after continuing TCZ for 24 other weeks.

Conclusion
Among patients with GC-dependent PMR, in remission after a 6-month TCZ treatment, only a quarter remained relapse-free after treatment discontinuation. This study suggests that a 6-month treatment is not enough to withdraw TCZ. Further studies assessing the required duration of anti-IL6-receptor treatment to limit PMR relapses are needed.

Conclusion: Among patients with GC-dependent PMR, in remission after a 6-month TCZ treatment, only a quarter remained relapse-free after treatment discontinuation. This study suggests that a 6-month treatment is not enough to withdraw TCZ. Further studies assessing the required duration of anti-IL6-receptor treatment to limit PMR relapses are needed.

Figure 1. Relapse-free survival among GC-dependent PMR patients in remission after a 6-month treatment of Tocilizumab
Footnotes: Remission was defined by PMR-AS<10, and GC≤5mg/j or daily GC dose decreased by ≥10mg. Day 0 was the visit at 24th week in the SEMAPHORE trial
Abbreviations: PMR: Polymyalgia rheumatica; PMR-AS: Polymyalgia rheumatica activity score

Disclosures: B. Chevet: None; A. Souki: None; n. emmanuel: None; G. CARVAJAL ALEGRIA: Abbvie, Chugai, Lilly, Novartis, 6; E. Dernis: AbbVie/Abbott, 2, Amgen, 2, Boehringer-Ingelheim, 2, Celgene, 2, Eli Lilly, 2, Galapagos, 2, Gilead, 2, Janssen, 2, Merck/MSD, 2, Nordic Pharma, 2, Novartis, 2, Pfizer, 2, Roche, 2, roche-chugaï, 2, Sandoz, 2, Sanofi, 2, UCB, 2; C. Richez: Abbvie, Astra Zeneca, BMS, GSK, Lilly, Novartis, Pfizer, UCB, 6, Lilly and Biogen, 5; M. Truchetet: None; D. WENDLING: None; E. TOUSSIROT: None; a. Perdriger: None; J. Gottenberg: AbbVie, 2, BMS, 2, 5, Galapagos, 2, Gilead, 2, Lilly, 2, MSD, 2, Novartis, 2, Pfizer, 2, 5; R. FELTEN: None; B. Fautrel: AbbVie, 2, 5, Amgen, 2, Biogen, 2, BMS, 2, Celgene, 2, Celltrion, 2, Chugai, 2, Fresenius Kabi, 2, Galapagos, 2, Janssen, 2, Lilly, 2, 5, Medac, 2, MSD, 2, 5, Mylan, 2, Nordic Pharma, 2, Novartis, 2, Pfizer, 2, 5, Roche, 2, Sandoz, 2, Sanofi-Genzyme, 2, Sobi, 2, UCB, 2; l. chiche: None; A. Walliser-Lohse: None; P. Hilliquin: None; C. Le Henaff: None; B. Dervieux: None; G. Direz: None; I. Valckenaere: None; D. Cornec: None; D. Guellec: None; T. Marhadou: Abbvie, Amgen, Chugaï, Lilly, Mylan, Novartis, Pfizer, 6; A. SARAUX: Abbvie, BMS, Galapagos, Lilly, Novartis, Nordic, Pfizer, Roche-Chugai, Sanofi, UCB, 6, Abbvie, Bms, Lilly, Novartis, 5; V. Devauchelle: AbbVie, 2, BMS, 2, 5, Chugai, 5, Galapagos, 2, Janssen, 2, Lilly, 2, 5, Novartis, 2, Pfizer, 2.

To cite this abstract in AMA style:

Chevet B, Souki A, emmanuel n, CARVAJAL ALEGRIA G, Dernis E, Richez C, Truchetet M, WENDLING D, TOUSSIROT E, Perdriger a, Gottenberg J, FELTEN R, Fautrel B, chiche l, Walliser-Lohse A, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Valckenaere I, Cornec D, Guellec D, Marhadou T, SARAUX A, Devauchelle V. Assessment of the Remission Maintenance After Tocilizumab Withdrawal in Polymyalgia Rheumatica Patients Receiving a 6-month Treatment [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/assessment-of-the-remission-maintenance-after-tocilizumab-withdrawal-in-polymyalgia-rheumatica-patients-receiving-a-6-month-treatment/. Accessed .

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