Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

Completed

• Conditions: Rheumatoid Arthritis; Drug Use
• Interventions: Drug: biologic/targeted therapy

• Registration Number: NCT05182203
• Lead Sponsor: Tuen Mun Hospital

Brief Summary

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

Detailed Description

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.

Study Timeline

• Study First Submitted: 2021-12-18
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-10
• Study Start: 2022-03-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1732

Inclusion Criteria

• All RA patients in our biologics registry treated with the JAK inhibitors (N=411)
• All RA patients in our biologics registry treated with the TNF inhibitors (N=1392)

Exclusion Criteria

• RA patients in our biologics registry treated with other biologic/targeted DMARDs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TNF inhibitors	biologic/targeted therapy	RA patients treated with TNF inhibitors
JAK inhibitors	biologic/targeted therapy	RA patients treated with JAK inhibitors

Primary Outcome Measures

Name	Time	Method
Withdrawal rate due to major / serious adverse events	from start of biologic/targeted DMARD use to these event(s) up to 10 years	adverse events eg. MACEs, malignancy, infections

Secondary Outcome Measures

Name	Time	Method
Withdrawal rate due to inefficacy	from start of biologic/targeted DMARD use to last clinic visit up to 10 years	Efficacy of the agents in terms of retention rate

Trial Locations

Locations (1)

Department of Medicine, Tuen Mun Hospital; 🇨🇳 Hong Kong, China