Continuation Versus Temporary Interruption of Immunomodulatory Agents During Infections in Patients With Inflammatory...

Area of Science:

• Rheumatology
• Infectious Diseases
• Clinical Trials

Background:

• Immunomodulatory agents (IA) are standard for inflammatory rheumatic diseases (IRDs).
• Current guidelines suggest interrupting IA during infections, but evidence is limited.
• The safety and efficacy of IA continuation versus interruption during infections require investigation.

Purpose of the Study:

• To compare the outcomes of continuing versus temporarily interrupting IA in IRD patients experiencing infections.
• To evaluate the risk of serious infections in both treatment strategies.

Main Methods:

• A multi-centre, open-label, randomised controlled trial was conducted.
• Infection-free IRD patients on IA were randomised to either continue or interrupt IA during infections.
• The primary outcome was the proportion of patients with serious infections, analysed in the modified intention-to-treat (mITT) population.

Main Results:

• Serious infections occurred in 5.15% of the interruption group and 3.73% of the continuation group.
• The adjusted risk difference was 1.71% (95% CI -1.99 to 5.39), indicating no significant difference.
• Complier Average Causal Effect (CACE) analysis favoured IA continuation.

Conclusions:

• Temporary interruption and continuation of IA result in similar risks and outcomes of infections in IRD patients.
• Continuation of IA during infection appears safe, despite the study's limited statistical power.
• Findings challenge current guidelines recommending IA interruption during infections.