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

Paul Bird,Geoffrey Littlejohn,Belinda Butcher,Catherine O’Sullivan,Tegan Smith,Hedley Griffiths,David Witcombe

doi:10.1007/s10067-021-05853-x

Paul Bird, Geoffrey Littlejohn + Show 5 more

Open Access

https://doi.org/10.1007/s10067-021-05853-x

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Abstract

ObjectiveThis 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).MethodsThis 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.ResultsIn 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).ConclusionsPatients 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.

Highlights

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation of the synovial tissue and destruction of the adjacent cartilage and bone [1]
This study explored the real-world clinical effectiveness and treatment persistence among patients with RA treated with monotherapy and combination tofacitinib and bDMARD therapy
The bDMARD group had a higher percentage of patients on their first line bDMARD compared to tofacitinib

Summary

Introduction

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation of the synovial tissue and destruction of the adjacent cartilage and bone [1]. The main goal of treatment is to manage the patients symptoms and preserve function by controlling inflammation and preventing progressive structural damage [3]. This is achieved through treatment with various combinations of therapies including analgesics, corticosteroids, and synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). In Australia, the cost of biologic or targeted synthetic DMARDs (b/tsDMARDs) for the treatment of RA is subsidized if the patient has documented high levels of clinical and laboratory disease activity and has not responded to a pre-specified combination of conventional synthetic DMARDs (csDMARDs), including at least two of methotrexate, hydroxychloroquine, sulfasalazine, or leflunomide [4]. The b/tsDMARD therapies available in Australia include the tumor necrosis factor inhibitors (TNFi) adalimumab, etanercept, certolizumab pegol, golimumab, and infliximab, the interleukin 6 inhibitor (IL6i); tocilizumab, the cytotoxic T-lymphocyte antigen 4 modified antibody; abatacept, the anti-CD20 monoclonal antibody; rituximab, and the more recent mode of action (MOA) therapy, the Janus kinase inhibitors (JAKi); tofacitinib, baricitinib, and upadacitinib [5]

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