OP0270 TAPERING OF LONG-TERM, LOW-DOSE GLUCOCORTICOIDS IN SENIOR RHEUMATOID ARTHRITIS PATIENTS: FOLLOW-UP OF THE PRAGMATIC, MULTICENTRE, PLACEBO-CONTROLLED GLORIA TRIAL

Background Guidelines suggest glucocorticoids (GC) should be used as bridge therapy in rheumatoid arthritis (RA), but many patients are treated chronically with low doses. The effects of withdrawal such has not been studied extensively. Objectives To study disease activity score (DAS28), flares and signs adrenal insufficiency after blinded trial medication (prednisolone 5 mg/day or placebo for 2 years). Methods 2-year, double-blind GLORIA evaluated the long-term benefits harms dose GC added to standard care (see main abstract). Senior RA (≥ 65 years) were randomly assigned prednisolone placebo. After final visit was linearly tapered zero 3 months by adding a stop day every two weeks, reassessed. Those who successfully completed did receive open-label during 4 weeks included this follow-up study. primary outcome change DAS28 at compared visit. Secondary outcomes occurrence (DAS28 increase > 0.6 between week 12 taper phase) insufficiency, assessed 9 items selected from 57-symptom list MDHAQ questionnaire (1) hypotension (systolic RR < 90 diastolic 60). In subset Dutch centres, cortisol ACTH measured spot serum samples Analysis covariance DAS28. Linear regression chi-square test remaining outcomes. Results 278 participants study, 21 received within end trial, 58 had missing data, leaving 199 eligible 34 open label excluded analysis. 165 (80 prednisolone, 85 placebo), mean (SD) higher on placebo: 3.14 (1.04) vs 2.92 (1.13) tapering, increased significantly (p=0.02) group 3.18 (1.20) stable (3.14). difference groups 0.21 (95%CI –0.05;0.47; p=0.11). For 33 out 60 72 (Table 1). Mean number 1.1 (1.1) versus 0.9 (1.3) 0.8 (1.2) (1.0) follow-up. Difference –0.1 –0.4;0.3; p=0.66). Table 1. Adrenal symptoms. (n=60) placebo(n=72) Fatigue (unusual) 15 1 13 –1 Appetite loss Muscle weakness 7 –2 6 Dizziness 10 Stomach pain 19 –6 Nausea –3 Vomiting 0 Diarrhoea Hypotension* Sum ** –0.2 0.0 * Systolic 60. **Mean No differences seen levels: 5.8 (4.1) 23 patients, 5.1 (3.7) 24 patients; 296 (113) v 310 (166), cortisol/ACTH 67 (40) 77 (54). Two one patient levels below 80. None developed clinical hypoadrenalism further qualified sample, 99 100 placebo; 44 flared tapering 31 placebo, relative risk 1.43 0.99; 2.07; p=0.07). Conclusion Tapering moderately increases (mean still levels) numerically flare without any evidence insufficiency. This suggests that is feasible years administration. References [1]DeWalt DA et al. Clin Exp Rheumatol. 2004;22:453-61. Acknowledgements registered clinicaltrials.gov under NCT02585258 . project funded European Union’s Horizon 2020 research innovation programme topic ‘’Personalizing Health Care’’, grant agreement 634886. Disclosure Interests Abdullah Almayali: declared, Maarten Boers Consultant of: Novartis, Linda Hartman: Daniela Opris-Belinski Abbvie, Pfizer, MSD, Eli Lilly, Ewo Pharma, UCB, Reinhard Bos: Marc R Kok: José Antonio P. da Silva: Eduard N. Griep: Ruth Klaasen: Cornelia Allaart: Paul Baudoin: Hennie Raterman AbbVie, Amgen, Celgene, Roche, Sandoz, Sanofi Genzyme Zoltán Szekanecz: Frank Buttgereit AstraZeneca, Gruenenthal, Therapeutics, Mundipharma, Pavol MASARYK: WIllem Lems Galapagos, UCB., Maurizio Cutolo: Marieke ter Wee: declared