Cost-utility of COBRA-light versus COBRA therapy in patients with early rheumatoid arthritis: the COBRA-light trial.

Autor:	Ter Wee MM; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands.; Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands., Coupé VM; Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands., den Uyl D; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands., Blomjous BS; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands., Kooijmans E; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands., Kerstens PJ; Westfriesgasthuis, Hoorn, The Netherlands., Nurmohamed MT; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands.; Amsterdam Rheumatology and Immunology Centre, Reade, Amsterdam, The Netherlands., van Schaardenburg D; Amsterdam Rheumatology and Immunology Centre, Reade, Amsterdam, The Netherlands.; Amsterdam Rheumatology and Immunology Centre, Academic Medical Centre, Amsterdam, The Netherlands., Voskuyl AE; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands., Boers M; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands.; Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands., Lems WF; Amsterdam Rheumatology and Immunology Centre, VU University Medical Center, Amsterdam, The Netherlands.; Amsterdam Rheumatology and Immunology Centre, Reade, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	RMD open [RMD Open] 2017 Oct 25; Vol. 3 (2), pp. e000502. Date of Electronic Publication: 2017 Oct 25 (Print Publication: 2017).
DOI:	10.1136/rmdopen-2017-000502
Abstrakt:	Objective: To evaluate if COmbinatie therapie Bij Reumatoïde Artritis (COBRA)-light therapy is cost-effective in treating patients with early rheumatoid arthritis (RA) compared with COBRA therapy. Methods: This economic evaluation was performed next to the open-label, randomised non-inferiority COBRA-light trial in 164 patients with early RA. Non-responders to COBRA or COBRA-light received etanercept (50 mg/week) for 3-6 months. The societal perspective analysis took medical direct, non-medical direct and indirect costs into account. Costs were measured with patient cost diaries for the follow-up period of 52 weeks. Bootstrapping techniques estimated uncertainty around the cost-effectiveness ratios, presented in cost-effectiveness planes. Results: 164 patients were randomised to either COBRA or COBRA-light strategy. At week 52, COBRA-light proved to be non-inferior to COBRA therapy on all clinical outcome measures. The results of the base-case cost-utility analysis (intention-to-treat analyses) revealed that COBRA-light strategy is more expensive (k€9.3 (SD 0.9) compared with COBRA (k€7.2 (SD 0.8)), but the difference in costs were not significant (k€2.0; 95% CI -0.3 to 4.4). Also, both strategies produced similar quality-adjusted life-years (QALYs). The sensitivity analyses showed robustness of these results. In a per-protocol sensitivity analysis, in which costs of etanercept were assumed to be provided as prescribed according to protocol, both arms had much higher costs: COBRA-light: k€11.5 (8.3) compared with k€8.5 (6.8) for COBRA, and the difference in costs was significant (k€2.9; 0.6 to 5.3). Conclusions: In the base-case cost-utility analysis, the two strategies produced similar QALYs for similar costs. But it is anticipated that if protocol had been followed correctly, the COBRA-light strategy would have been more costly due to additional etanercept costs, for a limited health gain. Given the limited added benefit and high costs of starting etanercept in the presence of low disease activity in our trial, such a strategy needs better justification than is available now. Trial Registration Number: 55552928, Results. Competing Interests: Competing interests: WFL has received speaker’s fee from Merck, AbbVie, Roche and Pfizer. MSN has received research grants from AbbVie, BMS, MSD, Pfizer, UCB and Roche. He has also acted as a consultant for AbbVie, BMS, Pfizer and Roche. Furthermore, he has participated in speakers bureau for AbbVie, BMS, Pfizer and Roche. All other authors have nothing to declare.
Databáze:	MEDLINE
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