Recent data published in BMJ Open support the use of etanercept as a first-line tumor necrosis factor inhibitor (TNFi) monotherapy and strengthen the currently recommended use of biologic disease-modifying antirheumatic drugs (bDMARDs) in combination with conventional synthetic DMARDS (csDMARDs) in patients with rheumatoid arthritis (RA).
The objective of the Record-linkage on Rheumatic Diseases (RECORD) analyses was to assess the persistence of treatment of different bDMARDs when administered as monotherapy compared with csDMARD combination therapy in patients with RA who received first-line biologic agents. The RECORD study was promoted by the Italian Society for Rheumatology to monitor the health burden of rheumatic diseases in Italy between 2004 and 2013.
A total of 4478 patients with RA were included in the study. Among the participants, 17.84% received bDMARD monotherapy and 82.16% were treated with csDMARDs. The most often prescribed bDMARDs included etanercept (39.91%), adalimumab (25.52%), and infliximab (19.23%). Etanercept was the most prescribed agent, both as monotherapy (48.19%) and as part of combination therapy (38.11%).
The use of bDMARD monotherapy was associated with a higher Charlson Comorbidity Index, longer disease duration, and lower use of nonsteroidal anti-inflammatory drugs or glucocorticoids. Compared with the use of monotherapy, the use of combination therapy with 1 or more csDMARD was associated with a lower risk for drug failure (adjusted hazard ratio [aHR], 0.79; 95% CI, 0.72-0.88).
Among participants receiving bDMARD monotherapy, when etanercept was used as the reference, the aHR for bDMARD failure was 1.28 with adalimumab (95% CI, 1.03-1.59) and 2.41 with infliximab (95% CI, 1.85-3.15). The use of concurrent csDMARDs significantly reduced the risk for bDMARD withdrawal (0.78 for concomitant methotrexate, 0.80 for leflunomide, and 0.77 for combination therapies). No statistically significant improvements in drug survival were observed with sulfasalazine, hydrochloroquine, or cyclosporine A when used as the combination csDMARD.
Investigators concluded that the results of this study support the recommended use of bDMARDs in combination with csDMARDs in patients with RA. The findings strengthen the positive influence of methotrexate, leflunomide, or a combination of csDMARDs in improving bDMARD persistence.
Silvagni E, Bortoluzzi A, Carrara G, Zanetti A, Govoni M, Scirè CA. Comparative effectiveness of first-line biological monotherapy use in rheumatoid arthritis: a retrospective analysis of the RECord-linkage On Rheumatic Diseases study on health care administrative databases. BMJ Open. 2018;8(9):e021447.