De COVID I2 studie: onderzoek naar het doorgebruiken of tijdelijk onderbreken van immuun-modulerende medicijnen bij patiënten die een infectie krijgen.

Immunomodulatory agents (IA) are widely used (>200,000 patients in the Netherlands) for the treatment of patients with immune-mediated inflammatory diseases (IMIDs) including rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, psoriasis and inflammatory bowel disease, and they are in general associated with a modestly increased risk of infection. However, it is not clear what risk factors for infection are, and whether it is wise to temporary interrupt IA treatment during an infection. Recently, the COVID-19 pandemic has dramatically increased the urgency to provide answers to these questions, especially since, surprisingly, some IA seem to be effective treatment against COVID-19. Therefore, the objectives of this study are to: 1) To assess the effect of continuation of IA treatment in IMID patients during an infection compared to temporary interruption of the IA treatment with regard to serious infection, and 2) to study the incidence and risk factors for infection in IMID patients using IA, with special attention for COVID-19. This study is a two arm, open-label pragmatic, explorative randomized controlled strategy study, among IMID patients using IA in the Netherlands. Adult patients with rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, psoriasis and inflammatory bowel disease using IA (except monotherapy rituximab or glucocorticoids) in any dose without a current infection will be included and randomized into either the intervention or control group. The intervention consists of continued IA treatment and the control condition is interruption of IA treatment until the infection is resolved, all in addition to standard of care. Main study parameters/endpoints: The primary outcome is serious infection (resulting in hospitalization, intravenous antibiotics, admission to the intensive care or death)

As this is an explorative design, no formal hypothesis is made. However, our sample size is based on a difference of 2.5% or more in cumulative incidence of serious infections when continuing IA, hypothesizing that patients who continue their IA in case of an infection experience less severe infections compared to patient who temporarily interrupt IA.

Patients will be followed for 12 months, receiving questionnaires at baseline and one each following month. If a patient experiences an infection at t = 12 months, he/she will be followed until the infection has passed. In addition, data will be collected in case of an infection.