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

Authors :
Kuwana M
Sugiyama N
Momohara S
Atsumi T
Takei S
Tamura N
Harigai M
Fujii T
Matsuno H
Takeuchi T
Yamamoto K
Takasaki Y
Tanigawa M
Endo Y
Hirose T
Morishima Y
Yoshii N
Mimori T
Takagi M
Source :
Modern rheumatology [Mod Rheumatol] 2024 Feb 26; Vol. 34 (2), pp. 272-286.
Publication Year :
2024

Abstract

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.<br />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. Risk factors for serious infections were assessed by multivariable analyses.<br />Results: Safety and disease activity were evaluated in 6866 and 6649 patients, respectively. Overall, 32.73%/7.37% of patients reported AEs/SAEs. Clinically important AEs with tofacitinib included serious infections/infestations [3.13% of patients; incidence rate (IR; patients with events) 6.91/100 patient-years (PY)], herpes zoster (3.63%; IR 8.02/100 PY), and malignancies (0.68%; IR 1.45/100 PY). SDAI/CDAI/DAS28-4(ESR) scores and remission/low disease activity rates improved over 6 months. Male sex, older age, Steinbrocker's stage IV, history of infection, and diabetes mellitus at baseline were independent risk factors for serious infection.<br />Conclusions: In patients with RA receiving tofacitinib in Japan, safety was consistent with the reported profile, and disease activity improved over 6 months.<br />Study Identifier: NCT01932372.<br /> (© Japan College of Rheumatology 2023. Published by Oxford University Press.)

Details

Language :
English
ISSN :
1439-7609
Volume :
34
Issue :
2
Database :
MEDLINE
Journal :
Modern rheumatology
Publication Type :
Academic Journal
Accession number :
37405710
Full Text :
https://doi.org/10.1093/mr/road063