BIOLOGIC-DMARDS AND TARGETED SYNTHETIC-DMARDS EFFECT ON RAPID WITHDRAWAL OF STEROID IN 6 MONTHS OBSERVATIONAL PERIOD IN RHEUMATOID ARTHRITIS PATIENT'S COHORT: REAL LIFE DATA EXTRACTED FROM BIOPURE REGISTRY.

C. Rotondo,A. Corrado, M. Fornaro, R. N. G. Bucci,G. Carlino, F. D'onofrio, P. C. F. Falappone, P. F. Leucci, A. Marsico, N. Maruotti, D. Mazzotta, L. Quarta, L. Santo,C. Scioscia,A. Semeraro, C. Zuccaro, E. Quarta,F. Iannone,F. P. Cantatore

Annals of the Rheumatic Diseases(2022)

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摘要
Background Considering the highest adverse events risk (predominantly infectious disease and osteoporosis) of glucocorticoids (GCs), EULAR recommended a short-term use of GCs with rapid tapering as soon as clinically feasible in rheumatoid arthritis (RA) patients. Although a prednisone dose less than or equal to 7,5 mg/die is considered more safety, the complete discontinuation of the GCs would be desirable. Few data are available on real tapering or withdrawal of GCs in RA patients treated with DMARDs both in clinical trial and registry study. Objectives To evaluate the steroid tapering rate and the discontinuation of GCs in RA patients treated with biological-DMARDs (b-DMARDs) or target synthetic DMARDs (ts-DMARDs) in different treatment lines. Methods We revised retrospectively 1616 clinical records of RA patients who started b/ts-DMARDs between December 2017 and June 2021. We recruited 420 RA patients who were stably treated for at least 6 months with b/ts-DMARDs with or without cs-DMARDs and were taken GCs at baseline visit. The evaluations of GCs discontinuation time were realized by Kaplan-Meier estimate, followed by log-rank (Mentel-Cox) test for the comparison among different b/ts-DMARDs groups. Statistical significance was set at p ⩽ 0.05. Results RA patients treated with different b/ts-DMARDs were comparable for disease duration (anti TNF-alpha: 76 weeks ± 64; JAK-I: 121 weeks ± 122; anti-IL6: 78 weeks ± 70; abatacept: 111 weeks ± 121), disease activity (DAS 28 ESR: anti TNF alpha: 3,9 ± 1,3; JAK-I: 4,1 ± 1; anti IL-6: 4 ± 1,3; abatacept: 4 ± 1,2; p=0,958), and GCs dose (anti TNF alpha: 5,7 mg ± 7,5; JAK-I 5,5 mg ± 2,5; anti IL-6 5,7 mg ± 4,1; abatacept 5,6 mg ± 2,5; p=0,879) at baseline visit. 158 RA patients started for the first-time b/ts-DMARDs, 83 patients started 2 nd line of b/ts-DMARDs, 66 patients started 3 rd line b/ts-DMARDs and 113 patients were failure to more than 3 b/ts-DMARDs. Considering RA patients who started b/ts-DMARDs for the first time, the groups treated with anti-IL6 or JAK-I showed a shorter discontinuation time than those treated with anti TNF-alpha or Abatacept (respectively 22 weeks ± 0,7, 22,6 weeks ± 0,7, 23,8 weeks ± 0,1, 23,1 weeks ± 0,4; p=0,046). As regards the steroid sparing in 6 th month of follow-up, the rates of GCs dose spared than the staring GCs dose were higher in JAK-I (44%) and anti-IL 6 (42%) compared to abatacept (30%) and anti-TNF alpha (33%). Considering the group of RA patients treated in 2 nd or other lines of b/ts-DMARDs, no differences were found among various treatments in GCs discontinuation time. Conclusion In clinical practice GCs are useful therapeutic tools to reach as rapidly as possible low disease activity in RA patients; but the possible adverse effects of long-term GCs treatment limit their use. The introduction of biotechnological drugs has significantly improved clinical management of RA patients, achieving the aim of rapid GCs discontinuation or their dose reduction. In particular, the mechanisms of action of anti-IL6 and JAK-I seems perform more quickly on steroid discontinuation than anti TNF alpha or abatacept, above all in 1 st line of b/ts-DMARDs in RA patients. Disclosure of Interests None declared
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