Real-world evaluation of effectiveness, persistence, and usage patterns of monotherapy and combination therapy tofacitinib in treatment of rheumatoid arthritis in Australia

Abstract

Objective This study aimed to describe the real-world effectiveness and treatment persistence among patients with rheumatoid arthritis treated with monotherapy and combination therapy tofacitinib and biologic disease-modifying antirheumatic drugs (bDMARDs). Methods This was a post hoc analysis of a retrospective, non-interventional study that extracted data for patients treated with tofacitinib or bDMARDs from the Australian OPAL dataset between March 2015 and September 2018. Monotherapy tofacitinib and bDMARDs and combination therapy tofactinib and bDMARDs were propensity score matched and treatment effectiveness and persistence of the groups were evaluated. Results In the bDMARD and tofacitinib monotherapy and combination therapy matched populations there were 1300 bDMARD initiators (n = 564 monotherapy) and 650 tofacitinib initiators (n = 282 monotherapy). In the bDMARD and tofacitinib monotherapy matched groups, 62.9% and 66.7% were in DAS-28 CRP disease remission after 18 months of treatment, respectively. In the combination therapy bDMARD and tofacitinib groups, 50% and 58.9% were in DAS-28 CRP disease remission after 18 months, respectively. The median treatment persistence was similar between the monotherapy bDMARD and tofacitinib treatment groups (36.7 months (95% CI 27.4 to “not reached’) and 34.2 months (95%CI 30.3 to “not reached”) respectively) as well as the combination therapy bDMARD and tofacitinib groups (32.2 months (95% CI 25.7 to 34.4) and 32.7 months (95%CI 28.7 to “not reached”, respectively). Conclusions Patients receiving combination therapy with tofacitinib or bDMARDs had higher disease activity scores at index than patients receiving monotherapy. Monotherapy with tofacitinib or bDMARDs, and combination therapy with tofacitinib or bDMARDs demonstrated similar treatment effectiveness and persistence, respectively. Key Points• This study provides real-world evidence regarding effectiveness, treatment persistence, and treatment patterns, among patients with rheumatoid arthritis (RA) treated with monotherapy or combination therapy tofacitinib.• The study suggests that monotherapy and combination therapy tofacitinib is an effective intervention in RA with persistence and effectiveness comparable to bDMARDs.

Long-Term Retention Rate of Tofacitinib in Rheumatoid Arthritis: An Italian Multicenter Retrospective Cohort Study

“…We then showed that none of the potential predictors of therapy discontinuation considered, including patient age, previous treatment with biologics, concomitant use of csDMARD, and positivity for RF and/or ACPA, were statistically significant after regression analysis. Similar data were reported by Bilgin et al [ 33 ], Movahedi et al [ 34 ], Bird et al [ 35 ], and Finckh et al [ 36 ], who found no relevant predicting factor for TOFA discontinuation. Our results are also in agreement with a recently published paper analyzing data from a Korean registry, in which no predictive factors for discontinuation of therapy were found, except RF and ACPA positivity, both of which were associated with higher drug retention rates [ 37 ].…”

Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study

“…However, both studies included higher proportions of treatment‐refractory (i.e., bDMARD‐experienced) patients than CANTORAL. Conversely, a study of the Australian OPAL real‐world data set, with a comparable proportion of bDMARD‐naive patients to CANTORAL, reported higher month 6 CDAI‐defined LDA and remission rates than in the current analysis ( 11 , 12 ). However, OPAL included a higher proportion of patients in remission at tofacitinib initiation, and patients had a lower median disease duration versus CANTORAL, which may explain these differences.…”

“…Overall, effectiveness and persistence in patients receiving tofacitinib with versus without csDMARDs were similar across real-world studies (12,13,18). In the tofacitinib global clinical trial program, a phase IIIb/IV study showed numeric efficacy differences favoring tofacitinib combination therapy versus monotherapy (34), while persistence with tofacitinib combination and monotherapy were comparable in long-term extension studies (30).…”

“…Real-world assessment is necessary to inform clinicians of appropriate treatment targets and to provide insights into safety outcomes in populations ineligible for clinical trials. Such benefit/ risk profile assessments of tofacitinib, and other JAK inhibitors in patients with RA have been described globally (10)(11)(12)(13)(14)(15)(16)(17)(18)(19). Demographic information and persistence of tofacitinib in Canadian patients with RA have been reported in an analysis of data from a patient-support program; however, clinical effectiveness or safety was not assessed (20).…”

Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes

“…Data from the Rheumatic Diseases Portuguese Register showed that 23% and 40% of patients achieved remission and LDA, respectively, after 6 months of treatment with TNF inhibitors [ 12 ], which is generally in line with our findings. However, in a post hoc analysis of an Australian non-interventional cohort study of patients with RA treated with bDMARDs (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, and tocilizumab), rates of remission were higher than those observed here: nearly 60% of patients achieved remission at 3 months, which increased to 64% after 18 months [ 13 ]. In contrast, in an analysis of data from the British Society for Rheumatology Biologics Registry for Rheumatoid Arthritis, only 10% of patients treated with infliximab, etanercept, or adalimumab achieved remission at 6 months [ 14 ].…”