Pos1433 Long-Term Follow-Up of Patients With Polymyalgia Rheumatica After Treatment With Interleukin-6 Inhibition

Background: Patients with Polymyalgia rheumatica (PMR) receive glucocorticoids (GC) as their main line of therapy. However, long term treatment for several years is required, and rate of relapses is high in these patients. In PMR-SPARE trial1 we could show that inhibition of IL-6 with tocilizumab for a total of 16 weeks in addition to a rapid GC tapering scheme in new-onset PMR patients is an effective therapeutic approach to reduce disease flares and cumulative GC dose. The progression of the disease following the discontinuation of tocilizumab, however, remains uncertain. Objectives: To assess relapse rates in PMR-patients after the end of PMR-SPARE study and compare it between patients who have received tocilizumab and those with placebo. Methods: Patients included into the multicenter, placebo-controlled, randomized PMR-SPARE trial were assessed retrospectively using medical records in terms of flare free survival. Flare of disease was defined as recurrence of symptoms consistent with PMR OR elevation of ESR/CRP related to active PMR PLUS a dose increase/initiation of GC OR initiation of a DMARD therapy. Patients were censored either at occurrence of flare or time of last observation at study center. An intention to treat approach including all patients randomized in the trial was done. Baseline characteristics between patients who have experienced a flare and those who didn't were compared in a descriptive manner. Kaplan-Meier curve and a log-rank test were performed to compare the two groups. Results: Data from 32 out of 36 patients previously included in the main trial were available. The mean follow-up time was 243 (±333) days. The mean age was 69.0 (±8.9) years, with 50% being female. Patients who had received tocilizumab during the trial exhibited a lower rate of flare compared to the placebo group (5 (29%) versus 9 (60%) of patients). A Kaplan Meier curve showed a significant difference in the log-rank test (p=0.026, Figure 1). When comparing the baseline characteristics of the patients who flared, a lower proportion of patients who finished the trial (64% vs. 84%, respectively) was found. Medication used to treat flare were mainly glucocorticoids (n=13), followed by tocilizumab (n=3) and methotrexate (n=2). Conclusion: Patients with PMR who were initially treated with tocilizumab showed lower rates of flare in a post-trial real life observation. REFERENCES: 1 Bonelli, M. et al. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial. Annals of the Rheumatic Diseases 81, 838–844 (2022). Acknowledgements: NIL. Disclosure of Interests: Daniel Mrak: None declared, Jutta Stieger: None declared, Angelika Lackner: None declared, Martina Durechova: None declared, Andreas Kerschbaumer: None declared, Daniel Aletaha The study was sponsored by the Medical University Vienna who received an unrestricted grant from Roche, the manufacturer of tocilizumab, who provided study drug and matching placebo., Michael Bonelli: None declared, Helga Lechner-Radner: None declared.