Treatment persistence of subcutaneous TNF inhibitors among Australian patients with immune-mediated rheumatic disease (IMRD)

Abstract

IntroductionTo describe the persistence of treatment with subcutaneous tumor necrosis factor inhibitors (TNFi) adalimumab, etanercept, and golimumab in immune-mediated rheumatic disease (rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis) by treatment sequence (first-line treatment, second-line or further lines of treatment).MethodsA retrospective cohort analysis was conducted using the Australian Commonwealth Department of Human Services Pharmaceutical Benefits Scheme 10% sample data from January 1, 2010, to June 30, 2016. Pharmaceutical Benefits Scheme indications were used to identify patient prescriptions for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. A patient was considered persistent until a 3-month gap period where a prescription was not dispensed. The 3-month gap interval was chosen because only 1% of all discontinuations occurred beyond this 3-month period.ResultsData from 2,612 first-line patients were included. Treatment discontinuation among first-line patients treated with etanercept or adalimumab was not significantly different from those treated with golimumab (HR 1.10, 95% CI 0.95–1.28, P=0.22; HR 1.06, 95% CI 0.93–1.22, P=0.39; respectively). Among the 1,276 patients in the second-line cohort (etanercept=41%, adalimumab=41%, golimumab=18%) discontinuation was significantly higher for patients on etanercept compared with golimumab (HR 1.24, 95% CI 1.03–1.50, P=0.03); but not for adalimumab compared with golimumab (HR 1.11, 95% CI 0.91–1.34, P=0.31). In the third-line setting, treatment persistence with etanercept was longer than golimumab (HR 0.75, 95% CI 0.59–0.96, P=0.02), but there was no difference between golimumab and adalimumab. Similar findings occurred in the propensity score matched population.ConclusionOur study shows there is variance in real-world persistence to TNFi in patients with immune-mediated rheumatic disease by line of therapy, with the time on therapy decreasing by line. Australian persistence has been reported at lower overall rates than international evidence.

Impact of a Patient Support Program on time to discontinuation of adalimumab in Australian adult patients with immune-mediated inflammatory diseases–an observational study

“…While comparably high adalimumab persistence rates have been reported in a Japanese population of RA patients [ 37 ], a previous retrospective study of real-world data from the Australian Optimising Patient outcome in Australian RheumatoLogy (OPAL) registry estimated a 12-month persistence rate of 54% among patients prescribed adalimumab for rheumatology indications between 2010 and 2016 [ 18 ]. Similarly low persistence rates were reported in two other retrospective studies analysing PBS 10% sample data from patients prescribed adalimumab for rheumatology indications, CD, or UC [ 38 , 39 ]. Missing post-baseline data in our prospective cohorts is an important factor to consider when interpreting the contrasting persistence rates compared with the retrospective cohorts in our study and the previous studies.…”

Is Real-world Evidence Really Real?

“…This was not reported in another retrospective cohort analysis of prescriptions recorded by the Australian Commonwealth Department of Human Services (Pharmaceutical Benefits Scheme), where no significant differences were found between first bDMARD persistence of adalimumab, etanercept, or GOL in patients with AS. 4 The disparity between this and the current study regarding first bDMARD persistence clearly illustrates the reality of real-world evidence-apparent inconsistency.…”

The long‐term persistence of tumor necrosis factor inhibitors in patients with moderate to severe immune‐mediated rheumatic diseases: A nation‐wide, population‐based real‐world study

“…However, the detection of anti‐drug antibodies varied by the sensitivity of assays, 26 and further study is needed to compare the reaction of antibodies between these TNFi agents 27 . However, the Australian study that included 2612 patients indicated there was no statistical difference of 60‐month drug persistence among first‐line treatment of etanercept, adalimumab or golimumab; 28 the inconsistent finding might due to the difference in race or the policy of drug approval between Australia and Taiwan.…”