Cost-effectiveness and cost-utility of add-on, low-dose prednisolone in patients with rheumatoid arthritis aged 65+: The pragmatic, multicenter, placebo-controlled GLORIA trial
L Hartman, M El Alili, M Cutolo, D Opris, Jap Da Silva, Z Szekanecz, F Buttgereit, P Masaryk, R Bos, M R Kok, S Paolino, Vmh Coupé, W F Lems, M Boers, GLORIA consortium, L Hartman, M El Alili, M Cutolo, D Opris, Jap Da Silva, Z Szekanecz, F Buttgereit, P Masaryk, R Bos, M R Kok, S Paolino, Vmh Coupé, W F Lems, M Boers, GLORIA consortium
Abstract
Background: The GLORIA placebo-controlled trial found a favorable balance of benefit and harm for two years of prednisolone (5 mg/day) as add-on treatment for rheumatoid arthritis (RA) patients aged 65+. This study evaluated the cost-effectiveness of low-dose prednisolone in the treatment of RA.
Methods: The economic evaluation had a societal perspective with a time horizon of two years. Cost data were collected with questionnaires and from recorded events, and valued with standard Dutch unit prices of 2017. The primary effectiveness outcome was the disease activity score in 28 joints (DAS28). For cost-utility, quality-adjusted life years (QALYs) were estimated from the EuroQol-5 Dimension (EQ-5D) questionnaire. Bootstrapping assessed the uncertainty around the average differences in costs and health outcomes.
Results: In total, 444 of 451 randomized patients were included in the modified intention-to-treat analysis. Patients had median four active comorbidities at baseline. Mean total costs over two years were k€10.8 in the prednisolone group, k€0.5 (95% CI -4.0; 1.8) lower than in the placebo group. Total direct medical costs were k€0.5 (95% CI -4.0; 1.5) lower in the prednisolone group. The mean number of QALYs was similar in both groups (difference 0.02 [-0.03; 0.06] in favor of prednisolone). The DAS28 was 0.38 lower in the prednisolone group than in the placebo group (0.19; 0.56).
Conclusion: With greater effectiveness (DAS28) at non-significantly lower costs, low-dose, add-on prednisolone is cost-effective for RA compared to placebo over two years. QALYs were equal in both groups, most likely due to the impact of multiple comorbidities.
Keywords: Clinical trial; Cost-effectiveness; Glucocorticoids; Rheumatoid arthritis.
Conflict of interest statement
Declaration of Competing Interests DO: Abbvie, Pfizer, MSD, Novartis, Eli Lilly, Ewo Pharma, UCB; FB: Abbvie, AstraZeneca, Gruenenthal, Horizon Therapeutics, Mundipharma, Pfizer, Roche; RB: Abbvie, Galapagos, Novartis, Pfizer; WFL: Pfizer, Galapagos, Lilly, Amgen, UCB; MB: Novartis.
Copyright © 2022. Published by Elsevier Inc.
Source: PubMed