Real-World Evidence for Baricitinib in the Treatment of Rheumatoid Arthritis in Spain: A Systematic Literature Review.

Abstract

Introduction: Baricitinib is a Janus kinase inhibitor approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) in adults who have responded inadequately, or are intolerant, to disease-modifying antirheumatic drugs (DMARDs). This systematic literature review was conducted to understand the use of baricitinib in RA in the real-world setting in Spain.

Methods: Embase and MEDLINE databases were systematically searched for publications (in English or Spanish) published between March 2017 and June 2023; Spanish data presented at national rheumatology congresses were also obtained, with a date limitation of 2021-2023.

Results: Nineteen eligible publications were identified (5 full papers, 14 conference abstracts), including more than 1000 patients who received baricitinib for RA in Spain. Most patients were older and female with long disease duration, and moderate-to-severe active disease. Studies included both biologic DMARD-experienced and DMARD-naïve patients, and most patients received baricitinib 4 mg/day. Baricitinib persistence ranged from 6 to 48 months, with ineffectiveness (primary or secondary) being the most frequently reported reason for discontinuation. Baricitinib was consistently shown to decrease disease activity, across all outcome measures (Disease Activity Score-28 for RA, the Simplified and Clinical Disease Activity Indexes, swollen and tender joint counts and patient-reported outcomes). Thirteen studies reported safety outcomes, with discontinuation rates due to adverse events ranging from 9.5 to 20%. Across these studies, adverse events of interest included eleven cases of herpes zoster, six serious infections, two major adverse cardiovascular events, and three malignant neoplasms.

Conclusion: These results suggest baricitinib is effective in the real-world setting in Spain, with a consistent safety profile, similar to findings reported in clinical studies and in real-world studies conducted in other countries.