Three-year safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: final analysis of an all-case post-marketing surveillance study.

Objective: Evaluate tofacitinib real-world safety/effectiveness in patients with rheumatoid arthritis in Japan in a 3-year all-case post-marketing surveillance study.

Methods: All patients with rheumatoid arthritis who initiated tofacitinib (07/30/2013-12/03/2017) were registered in Japan. Serious infections/malignancy/mortality incidence were compared in patients with active rheumatoid arthritis after >8 mg methotrexate/week for ≥3 months who received tofacitinib or other drugs (control: methotrexate/other disease-modifying antirheumatic drugs/immunosuppressants).

Six-month safety and effectiveness of tofacitinib in patients with rheumatoid arthritis in Japan: Interim analysis of post-marketing surveillance.

Objectives: We evaluated the real-world safety/effectiveness of tofacitinib, an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA), in patients with RA in Japan registered in a post-marketing surveillance study.

Methods: This interim analysis included data from July 2013 to December 2018. Adverse events (AEs), serious AEs (SAEs), Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)/Disease Activity Score in 28 joints, erythrocyte sedimentation rate [DAS28-4(ESR)] scores, and rates of SDAI/CDAI/DAS28-4(ESR)-defined remission and low disease activity were analysed using 6 months of data.

Pretreatment Prediction of Individual Rheumatoid Arthritis Patients' Response to Anti-Cytokine Therapy Using Serum Cytokine/Chemokine/Soluble Receptor Biomarkers.

Unlabelled: The inability to match rheumatoid arthritis (RA) patients with the anti-cytokine agent most efficacious for them is a major hindrance to patients’ speedy recovery and to the clinical use of anti-cytokine therapy. Identifying predictive biomarkers that can assist in matching RA patients with more suitable anti-cytokine treatment was our aim in this report. The sample consisted of 138 RA patients (naïve and non-naïve) who were administered tocilizumab or etanercept for a minimum of 16 weeks as a prescribed RA treatment.