Long-Term Effectiveness of Adalimumab in Patients with Rheumatoid Arthritis: An Observational Analysis from the Corrona Rheumatoid Arthritis Registry

Abstract

Introduction Current recommendations for the management of rheumatoid arthritis (RA) focus on a treat-to-target approach with the objective of maximizing long-term health-related quality-of-life in patients with RA. Published studies from randomized clinical trials have reported limited data regarding the long-term efficacy and safety of adalimumab in patients with RA. This study aims to evaluate the long-term (10+ years) persistency and effectiveness of adalimumab in patients with RA in a real-world setting. Methods Included in this study were biologic-naïve adults with RA initiating adalimumab during follow-up enrolled in the Corrona RA registry. More than 10 years of data on persistency of adalimumab and rheumatologist-supplied reasons for discontinuation were examined. Among patients who persisted on adalimumab over the years, clinical [e.g., clinical disease activity index scores (CDAI), physician global assessment, tender joint count, and swollen joint count] and patient-reported outcomes (PRO), such as physical function, pain, fatigue, and morning stiffness, were examined. Results Of 1791 biologic-naive patients treated with adalimumab who had ≥1 follow-up registry visit, 64.1% were still on therapy at 1 year and 10.2% were still on therapy by the end of year 12. Among patients who persisted on adalimumab for at least 1 year (77.1% female, mean age 53.9 years), 67.0% were in low disease activity (LDA)/remission (CDAI ≤10) and had clinically meaningful improvements from baseline in all clinical assessments and PROs. Initial improvements in LDA/remission and in clinical and PRO assessments observed at year 1 were sustained in those patients who remained on adalimumab over 10 years of follow-up. Among patients who discontinued adalimumab, 61.6% were not in LDA/remission and 41.9% switched to another biologic within 12 months after discontinuing adalimumab. Conclusions Real-world data demonstrate a sustained effectiveness of adalimumab in the treatment of RA for patients who remained on therapy for 10 years. Funding Corrona, LLC and AbbVie.

Effectiveness and safety of certolizumab pegol in rheumatoid arthritis patients in Canadian practice: 2-year results from the observational FαsT-CAN study

“…28 Improvements in morning stiffness have previously been observed in patients treated with adalimumab (from the Corrona registry) and etanercept or infliximab compared with patients not receiving anti-TNF treatment, which complement the findings of the present study. 29,30 No new safety signals were identified and the incidence of CZP-related TEAEs were in line with the known safety profile of CZP. 5,6 The limitations of the study included the use of DAS28(CRP) as the preferred measure for the primary outcome as this was not validated in the most recent European League Against Rheumatism (EULAR) recommendations for the management of RA.…”

“…28 Improvements in morning stiffness have previously been observed in patients treated with adalimumab (from the Corrona registry) and etanercept or infliximab compared with patients not receiving anti-TNF treatment, which complement the findings of the present study. 29,30…”

Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)

“…Adalimumab reference product (RP; Humira, AbbVie Ltd, Maidenhead, UK), a fully human monoclonal antibody, has received regulatory approval for RA and several other diseases including psoriatic arthritis, inflammatory bowel disease, plaque psoriasis, axial spondyloarthritis, uveitis, and hidradenitis suppurativa [10,11]. The benefits of adalimumab have been well established in long-term trials and large registries such as the Corrona registry [12][13][14].…”

The longitudinal effect of biologic use on patient outcomes (disease activity, function, and disease severity) within a rheumatoid arthritis registry

“…Registry study data can be used to examine whether longer-term exposure to a biologic maintains the benefits for reduced disease activity and function impairment. Previous analyses of registry data have shown that RA patients who respond to biologic therapy in the first 6-12 months usually experience persistent benefits if they continue biologic therapy for several years [15][16][17][18][19][20][21][22][23][24]. The objective of this analysis was to examine the effect of cumulative exposure to biologics on patient outcomes over time, as well as predictors for improvement in outcomes.…”