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Comparative Effectiveness of Certolizumab Pegol, Abatacept, and Biosimilar Infliximab in Patients With Rheumatoid Arthritis Treated in Routine Care: Observational Data From the Danish DANBIO Registry Emulating a Randomized Trial
Author(s) -
Grøn Kathrine L.,
Glintborg Bente,
Nørgaard Mette,
Mehnert Frank,
Østergaard Mikkel,
Dreyer Lene,
Krogh Niels S.,
Bjørner Jakob B.,
Hetland Merete L.
Publication year - 2019
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.41031
Subject(s) - medicine , certolizumab pegol , abatacept , golimumab , infliximab , rheumatoid arthritis , observational study , concomitant , randomized controlled trial , mallinckrodt , cohort , etanercept , physical therapy , disease , family medicine , rituximab , lymphoma
Objective Nationwide Danish guidelines regarding rheumatoid arthritis ( RA ) patients initiating biologic treatment (i.e., biologic disease‐modifying antirheumatic drugs [ DMARD s]) are issued on an approximately annual basis. For biologics‐naive patients treated with concomitant methotrexate, mandatory medications included certolizumab pegol ( CZP ; year 2013–2014, recommended compliance 80%), abatacept ( ABA ; 2014–2015, 80%), and biosimilar infliximab ( CT ‐P13; 2015–2016, 50%). We hypothesized that these guidelines could be perceived as a surrogate randomization tool in which calendar period rather than patient‐specific factors defined the choice of the biologic DMARD . We undertook this study to assess compliance with guidelines (supporting the assumption of surrogate randomization) and to compare the effectiveness of CZP , ABA , and CT ‐P13 in patients treated according to guidelines. Methods This was an observational cohort study emulating a randomized trial (using intent‐to‐treat analyses). RA patients compliant with the treatment guidelines were identified in DANBIO , and information on prior comorbidities was obtained by linking to national registries. Outcome measures included remission rates according to the Disease Activity Score in 28 joints ( DAS 28) (at 6 and 12 months) and treatment retention at 1 year, compared across treatment regimens. Comorbidity/confounder‐adjusted multivariable logistic and Cox regression analyses were used. Results Seven hundred seventy‐six patients were included in the study (336 receiving CZP , 215 receiving ABA , 225 receiving CT ‐P13). Compliance with treatment guidelines was high: 70%, 65%, and 59%, respectively. Six‐month DAS 28 remission rates were 35%, 33%, and 42%, and 12‐month rates were 35%, 31%, and 35%, respectively. Compared to CZP , adjusted odds ratios for 6‐ and 12‐month DAS 28 remission rates were 0.96 (95% confidence interval [95% CI ] 0.63–1.47) and 0.74 (95% CI 0.47–1.15) for ABA and 1.38 (95% CI 0.91–2.09) and 0.96 (95% CI 0.62–1.49) for CT ‐P13, respectively. Adjusted hazard ratios for withdrawal (during days 0–90 and days 91–365) were 0.70 (95% CI 0.39–1.27) and 1.16 (95% CI 0.84–1.60) for ABA and 0.58 (95% CI 0.33–1.10) and 0.83 (95% CI 0.59–1.17) for CT ‐P13, respectively, compared to CZP . Conclusion The surrogate randomization procedure enabled head‐to‐head comparisons of CZP , ABA , and CT ‐P13. Although some differences in estimated effectiveness were observed across drugs, confidence intervals were wide and statistical significance was not reached.