TBA (19A150)

A Network Meta-Analysis to Evaluate the Efficacy of Baricitinib and Other Treatments of Rheumatoid Arthritis in Patients who Are Inadequate Responders to Methotrexate

Author(s)

Josef S Smolen1, Paul Emery2, Jean Dudler3, Cristiano Zerbini4, Walid Fakhouri5, Claudia Nicolay6, Inmaculada de la Torre7, Gerd R Burmester8

Department(s)/Institutions

1Medical University of Vienna, Vienna, Austria; 2Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK; 3HFR Fribourg Hopital Cantonal, Fribourg, Switzerland; 4Centro Paulista de Investiga Sao Paulo Clinica, Sao Paulo, Brazil; 5Eli Lilly and Company, Windlesham, Surrey, UK; 6Eli Lilly and Company, Lilly Deutschland GmbH, Bad Homburg, Germany; 7Eli Lilly and Company, Indianapolis, IN, USA; 8Department of Rheumatology and Clinical Immunology, Charité - University Medicine Berlin, Berlin, Germany

Introduction

Baricitinib (BARI), an oral, selective inhibitor of Janus kinase (JAK)1/2, is used to treat moderate to severe rheumatoid arthritis (RA) in adults.

Aims/Background

To assess the comparative effectiveness of BARI 4-mg (background MTX) and other targeted synthetic/biologic disease modifying anti-rheumatic drugs in moderate-to-severe RA patients with inadequate response to methotrexate (MTX-IR).

Method

A systematic literature review (SLR) of randomized controlled trials (RCTs; Phase 3) of interventions of interest was conducted (1999 to 2017) in Medline, Medline In-Process, Embase, Biosciences Information Service, the Cochrane Library, and trials registers. Network meta-analyses (NMAs) of RCTs reporting the American College of Rheumatology (ACR) response data were conducted using Bayesian mixed-treatment comparisons. Here, we present main results for the 24-week (±4) time point (fixed-effects simultaneous models).

Results

Totally, 24 trials met the SLR inclusion criteria. Analyses, using BARI RA-BEAM trial data, showed BARI 4 mg (background MTX) to be more effective than adalimumab (ADA) 40-mg (EOW; odds ratio [OR] 1.33; 95% credible interval [CrI] 1.01-1.75), abatacept (ABA) 10-mg (IV/4 weeks; OR 1.47; 95%CrI 1.02-2.13), and infliximab 3-mg (IV/8 weeks; OR 1.61; 95%CrI 1.12-2.27) for ACR20. While no differences were found on ACR50, BARI 4-mg (background MTX) was found to be more effective than ADA 40-mg (OR 1.39; 95%CrI 1.02-1.89), ABA 10-mg (OR 1.85; 95%CrI 1.09-3.23), rituximab (RTX) 1000-mg (OR 2.38; 95%CrI 1.10-5.00) and 2000-mg (OR 2.44; 95%CrI 1.04-5.56) for ACR70. BARI 4-mg (background MTX) showed better results than etanercept monotherapy (50 mg/week or 25 mg/biweekly; OR 2.27; 95%CrI 1.04-5.26) for ACR20, and RTX 1000-mg monotherapy for ACR20/ACR70 (OR 1.82; 95%CrI 1.02-3.13)/(OR 2.70; 95%CrI 1.04-7.14). Sensitivity analysis including 10 additional trials with up to 20% of patients with prior biologic use allowed comparison versus tofacitinib (TOFA), showing BARI 4-mg (background MTX) is more effective than TOFA 5 mg (BID) monotherapy for ACR20 (OR 1.92; 95%CrI 1.32-2.86).

Conclusions

The comparative analyses support BARI as an efficacious treatment option for moderate-to-severe RA patients with MTX-IR.

Previously presented at ISPOR-EU (2018).