Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Systematic review and meta-analysis
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

BARICITINIB
DECERNOTINIB
FILGOTINIB MALEATE
PEFICITINIB
TOFACITINIB
UPADACITINIB

Medical condition to be studied

Rheumatoid arthritis
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

1000000
Study design details

Main study objective

Assess the risk of infections associated with the use of JAK inhibitors in rheumatoid arthritis, as well as to explore risk variations due to risk factors, study designs and methodological quality of included studies

Outcomes

Assess the risk of serious infections with the use of JAK inhibitors in rheumatoid arthritis

Data analysis plan

Odds ratios (ORs) and their 95% confidence intervals (CIs) will be pooled. The risk estimates will be considered statistically significant if the 95%CI do not contain the value 1. A network map linking all the pharmacological treatments will be formed.The network meta-analyses and forest-plot diagrams will be designed using a random-effects model. The inconsistency test will be conducted in order to assess the extent of disagreement between the direct and indirect evidence. A comparison-adjusted funnel plot will be used to test small-study effect and publication bias. For each outcome, treatments will be ranked according to the probability of being the safest (best) alternative using the surface under the cumulative ranking curve (SUCRA), expressed as a percentage. All the statistics will be performed using STATA (version 13.1.).
Documents
Study publications
Alves C, Penedones A, Mendes D, Batel-Marques F. Risk of infections and cardiov…