Drug survival of adalimumab in patients with rheumatoid arthritis over 10 years in the real-world settings: high rate remission together with normal function ability

Abstract

The purpose of the study was to estimate the clinical profile of naïve biological patients with rheumatoid arthritis (RA) starting adalimumab through 3-year calendar periods and their clinical outcomes such as drug survival and global clinical disease control (GCDC). RA patients starting adalimumab as first biological drug between 2003 and 2012 were subdivided in 3-year calendar periods. Survival on therapy was estimated using the Kaplan-Meier analysis. One and 2-year clinical response was assessed by calculating percentage of patients attaining GCDC (28-joint Disease Activity Score (DAS28) ≤ 2.6 + Health Assessment Questionnaire (HAQ) ≤ 0.5), low disease activity (DAS28 ≤ 3.2), remission (DAS28 ≤ 2.6) and good European League Against Rheumatism (EULAR) response. Multivariate regression models were used to assess baseline predictors of drug discontinuation or achievement of clinical remission. We recruited 1695 RA patients. Overall drug persistence at 3 years was 40.6 %, while the global rate of nonswitching patients was 54.7 %. Compared to 2003-2005, initiators in more recent years had a significantly lower 3-year crude drug retention rate (log rank, p < 0.0001) and a significantly higher rate of switching to alternative biologics (log rank, p < 0.0001). No difference in adverse events or effectiveness rate among the calendar periods was found. A substantial proportion of patients (up to 27 %) achieved GCDC at 2 years, regardless of the calendar period. In real-life setting, RA patients starting adalimumab in more recent years had a higher rate of drug discontinuation not related to ineffectiveness or side effects but to switching, probably due to a wider availability of biologics. A meaningful proportion of patients attained GCDC without any difference across calendar periods.

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

“…Thus, patients in Corrona are more representative of the general population than patients participating in randomized, controlled clinical trials, making it more likely that the persistent benefits seen with long-term adalimumab treatment will also be observed in the general population. Similar observational results focusing on long-term effectiveness have been reported in the literature reporting persistence between 22% and 41% by 3 years, but these studies did not observe patients for the length of time ours did [35,36]. A multitude of other observational and registry derived data are available which either followed patients for fewer years [37] or had followed considerably fewer patients [38].…”

Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis

“…showed data on the survival of ADA treatment used as a first line bDMARD in a large multi-center RA population. 19 At 3 years, ADA retention rate was 40.6%, with a relative 15–20% drug interruption per year. Similar numbers were also confirmed by Favalli et al ., 20 showing 10-year treatment retention with ADA in 23.5% of a mixed population of RA, PsA, and axSPA.…”

<p>Emerging Role of Fractalkine in the Treatment of Rheumatic Diseases</p>

“… 90 – 92 However, about 50–70% of patients fail to achieve remission or to maintain low disease activity, even if they initially respond well to current therapies. 93 , 94 …”