Background Biologic agents have revolutionised the treatment of rheumatoid arthritis (RA). Few comparative, long-term data on treatment effectiveness and safety in the real world exist for patients typically seen in clinical practice.
Objectives To present the study design and baseline characteristics for 411 patients enrolled in the CORRONA CERTAIN study from 28 Oct 2010 to 30 Sept 2011.
Methods The CORRONA registry is a network of over 100 private and academic rheumatology practices across the US. The CORRONA CERTAIN is a comparative effectiveness prospective cohort study of adult patients with RA conducted across CORRONA participating sites. Patients with moderate disease activity (CDAI score >10) initiating a biologic agent (either for the first time or switching from a previous biologic) are eligible to enroll in CERTAIN. Physician and patient assessments, including lab values and biomarkers, are mandated at baseline, 3-, 6-, 9- and 12-month follow-up visits. A total of 2,750 patients will be enrolled over 3 years. The primary endpoint of CERTAIN is CDAI <10, and comparative safety will also be evaluated.
Results Enrolled patients are 76.7% female, 84.3% Caucasian; median age is 56 (IQR: 47-64). Age, sex and race distributions are similar in TNF and nTNF cohorts. About 62% of the patients were initiated on a TNF and 38% on nTNF. Disease duration was 3 years (IQR: 1-8) for TNF cohort and 9 years (IQR: 3-16) for nTNF cohort. Biologic initiations included: etanercept (17.0%), adalimumab (16.5%), abatacept (16.3%), tocilizumab (15.8%), certolizumab (12.9%), infliximab (10.5%), rituximab (6.1%) and golimumab (4.9%). Monotherapy was used in 34.6% of TNF patients and 37.6% of nTNF patients. Fifty-four percent of TNF and 8.3% of the nTNF initiators were biologic naive. Among patients previously exposed to a different biologic, reasons for discontinuing the previous biologic were failure to maintain response (35%), minor side effect (12%), inadequate initial response (9%) and serious side effect (3%). For the TNF cohort, median baseline values were 25.0 (IQR: 17.0-34.0) for CDAI, 4.5 (IQR: 3.7-5.4) for DAS28 (CRP) and 5.0 (IQR: 1.7-10.8) for CRP. Corresponding values for the nTNF cohort were 29.0 (IQR: 23.0- 37.0), 5.0 (IQR: 4.3- 5.6) and 4.9 (IQR: 1.6-16.0). At baseline 14.9% of the TNF initiators and 9.7% of the nTNF initiators had total cholesterol >240 mg/dl. Among the patients enrolled, 30.4% had HTN, 8.5% had diabetes, 7.3% had a history of CVD and 5.4% reported a history of cancer.
Conclusions The CERTAIN study will generate comparative effectiveness and safety data to improve the quality of care and treatment outcomes for RA patients on biologics.
Disclosure of Interest D. Pappas: None Declared, A. John Employee of: Roche/Genentech, J. Greenberg Shareholder of: CORRONA, Consultant for: AstraZeneca, Novartis, Pfizer, CORRONA, J. Devenport Employee of: Roche/Genentech, J. Kremer Shareholder of: CORRONA, Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Genentech, Lilly, Pfizer, Consultant for: Amgen, Genentech, Lilly, Pfizer, Employee of: CORRONA, Speakers Bureau: Abbott, Amgen, BMS, Pfizer, S. Ogale Employee of: Roche/Genentech, G. Reed Grant/Research support from: CORRONA, Consultant for: CORRONA, Employee of: University of Massachusetts Medical School, Paid Instructor for: Harvard Medical School, K. Saunders: None Declared, J. Curtis Grant/Research support from: Roche/Genentech, UCB, Centocor, BMS, Abbott, Amgen, CORRONA, Pfizer, Consultant for: Roche/Genentech, UCB, Centocor, BMS, Abbott, Amgen, CORRONA, Pfizer