Det sker ofte at immunsuppresiva pauseres i forbindelse med infektioner. Baggrunden er at immunosuppresiva kan være med at forværre infektioner, fordi immunforsvaret bliver dæmpende. På den anden side kan man risikere opblussen af den sygdom der behandles eller i tilfælde af transplantationer se komplikationer til disse.
Et nyt RCT kigger på sikkerheden ved at fortsætte immundæmpende medicin under en aktuel infektion. Det er et multicenter RCT omfattende 1.142 deltagere, der fik immunsuppresiva til behandling af inflammatorisk reumatisk sygdom (IRD). Da deltagerne fik deres første klinisk betydende infektion blev de randomiseret til enten at fortsætte eller pausere immunsuppresiva. Det primære outcome var andelen af deltagere der fik en alvorlig infektion der krævede indlæggelse eller i.v. behandling.
Resultatet var at der blev set alvorlige infektioner i 3,73% tilfælde af dem der fortsættede den immundæmpende medicin og 5,15% af dem der pauserede medicinen, hvor der ikke var statistisk signifikant forskel mellem de to risici.
Continuation Versus Temporary Interruption of Immunomodulatory Agents During Infections in Patients With Inflammatory Rheumatic Diseases: A Randomized Controlled Trial
METHODS: We conducted a large multi-center, open-label, randomized controlled trial (Dutch Trial Register (NL8922), in which infection-free IRD patients on IA were randomized 1:1 to either continue or temporarily interrupt IA treatment when experiencing their first clinically relevant infection. Primary outcome was the proportion of patients with a serious infection (requiring hospitalization or intravenous treatment), analyzed in the modified intention-to-treat (mITT) population using the Cochran-Mantel-Haenszel method. The mITT population included all patients who experienced a clinically relevant infection during follow-up. Secondary analyses included Complier Average Causal Effect (CACE) models to account for non-adherence.
RESULTS: Of 1142 patients enrolled (1667 patient years of follow-up), 474 developed a clinically relevant infection (mITT population). Serious infections occurred in 12 of 233 patients (5.15%) in the interruption group and in 9 of 241 (3.73%) in the continuation group, adjusted risk difference was 1.71% (95% CI -1.99 to 5.39). CACE analysis showed a risk difference of 4.51 (95% confidence interval [CI]: -7.32 to 16.34) in favor of continuation.
CONCLUSIONS: These findings suggest that temporary interruption and continuation of IA result in similar risk and outcome of infections in IRD patients. Although his study is limited by low statistical power, the findings suggest that continuation of IA during an infection is safe.
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