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Ab0461 what happens to corticosteroid therapy, one year after the introduction of targeted therapy in ra? results of the stratege 2 study

Annals of the Rheumatic Diseases(2023)

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Background The EULAR 2022 guidelines for the management of rheumatoid arthritis (RA) recommends methotrexate (MTX) combined with short-term corticoids (CS) as a 1st line standard of care [1]. In the event of an inadequate response to MTX and the presence of a poor RA prognosis factor, recommendations include initiation of biological (bDMARD) or synthetic (tsDMARD) targeted therapy in combination with MTX. Corticoids should be tapered as clinically feasible. Objectives Based on inclusion results of STRATEGE 2, we explore the evolution of therapeutic strategies after the initiation of a 1st b/tsDMARD, focusing on CS. Then patients’ profiles with or without CS were investigated. Methods STRATEGE2 is a non-interventional, prospective study including RA patients treated with MTX for at least 3 months and requiring initiation of a first b/tsDMARD due to disease activity. Evolution of main treatments was followed during 12 months. Data regarding therapeutic strategies were collected at inclusion (baseline treatment and end-of-visit prescription) and at 12 months (treatment at the 12 months visit entry and the end-of-visit prescription). Results Between Feb. 2019 and Dec. 2020, 186 RA patients were included, among them 173 being reviewed at the 12 months visit. Cohort baseline conditions: 75.1% female, mean age 56.1 ± 13.7 years, mean diagnostic oldness of 5.6 ± 7.3 years, MTX treatment since 4.3 ± 5.4 years. At the end of the inclusion visit, rheumatologists initiated a first targeted therapy. Then, patients were reviewed 12 months after inclusion (377.8 ± 41.5 days). Patients’ clinical conditions and treatments prescriptions are presented in the Table 1 here after. Table 1. Inclusion consultation N = 173 12 months after inclusion N= 171 Baseline condition After b/tsDMARD Prescription Entry After prescription Mean DAS28 4.3 ±1.2 2.6 ±1.1 Radiographic features, n (%) 82 (47.7) NA Radiographic progression, n (%) NA 5 (3.3) Extra-articular manifestations, n (%) 27 (16.2) 11 (6.7) Mean HAQ 1.0 ±0.7 0.7 ±0.7 MTX (N + Discontinued) → Mean dosage (mg/week) → SC (%) 173 18.8 ± 4.2 71.7 169 + 4 17.9 ± 4.4 66.9 143 + 28 16.4 ± 4.5 59.4 141 + 30 16.0 ± 4.5 59.4 b/tsDMARD (N*+ Discontinued) NA 173 149*+18 148*+19 Corticosteroids therapy (N*) → Yes, n (%) → Mean dosage (mg/day) → Median (Q1-Q3) → Min-Max 172 86 (50.0) 9.6 ± 6.0 7.5 (5.0-10.0) 2.5-30.0 172 80 (46.5) 8.6 ± 4.9 7.5 (5.0-10.0) 2.5-20.0 170* 66 (38.8) 9.1 ± 9.0 5.0 (5.0-10.0) 2.0-60.0 170* 68 (40.0) 9.7 ± 10.9 5.0 (5.0-10.0) 2.5-60.0 N* excludes missing data Differences between patients’ profiles with or without CS were investigated. At baseline, profiles tend to show some differences between patients treated by CS vs others compared to the full population: Age (57.4 ± 14.1 vs 54.9 ± 13.2; full population mean: 56.1 ± 13.7), unemployed (50.0% vs 34.9%; full: 43.9%), normal body mass index (38.4% vs 51.2%; full: 44.6%), at least one comorbidity (48.8% vs 54.7%; full: 51.4%) and DAS28 score (4.5 ± 1.1 vs 4.1 ± 1.2; full: 4.3 ± 1.2). At 12 months, the number of patients treated by CS decrease (from 50 to 40%). Patients’ profiles still treated by CS are similar to inclusion except for “at least one comorbidity” (54.4% vs 50.0%; full: 51.4%). Conclusion One year after the initiation of a b/tsDMARD the proportion of patients treated by CS is still important with high doses. These patients are older, present comorbidities and active disease. This long-term maintenance of CS is not in line with the Eular guidelines which recommend discontinuing CS as rapidly as clinically feasible. Further analyses on patients’ profiles are ongoing and supplementary data on 24 months follow-up may help to better understand the use of long-term CS in those patients. Reference [1]Smolen JS, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis 2023;82:3–18. Acknowledgements The authors wish to acknowledge RCTs for their contribution to the statistical analysis, the investigators, centres and patients. Disclosure of Interests Cécile Gaujoux-Viala Consultant of: AbbVie; Amgen; Boehringer Ingelheim, Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB Pharma., Grant/research support from: AbbVie; Amgen; Boehringer Ingelheim, Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences, Inc.; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; and UCB Pharma., Emmanuelle Dernis Consultant of: Emmanuelle Dernis (MAJ 06/2022): AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MSD, Nordic Pharma, Novartis, Pfizer, Roche, Roche-Chugaï, Sandoz, Sanofi and UCB Pharma., Grant/research support from: Emmanuelle Dernis (MAJ 06/2022): AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MSD, Nordic Pharma, Novartis, Pfizer, Roche, Roche-Chugaï, Sandoz, Sanofi and UCB Pharma., Eric Senbel Consultant of: Abbvie, Amgen, Biogen, Celltrion, Fresenius Kabi, Janssen, Lilly, MSD, Nordic Pharma, Pfizer, Roche-Chugai and Sandoz, Sanofi., Grant/research support from: Abbvie, Amgen, Biogen, Celltrion, Fresenius Kabi, Janssen, Lilly, MSD, Nordic Pharma, Pfizer, Roche-Chugai and Sandoz, Sanofi., Hélène Herman-Demars Employee of: Nordic Pharma France, Jennifer Becker Employee of: Nordic Pharma France, Agnès Courbeyrette Employee of: Nordic Pharma France, René-Marc Flipo Consultant of: Abbvie, Bristol-Myers Squibb, Eli-Lilly, Janssen, MSD, Nordic-Pharma, Novartis, Pfizer, Roche-Chugaï, Sandoz and Sanofi., Grant/research support from: Abbvie, Bristol-Myers Squibb, Eli-Lilly, Janssen, MSD, Nordic-Pharma, Novartis, Pfizer, Roche-Chugaï, Sandoz and Sanofi.
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corticosteroid therapy,targeted therapy
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