Onderzoek naar het voorspellen van het effect van biologicals op de ziekteactiviteit van een individuele patiënt met reumatoïde artritis (RA)

Background: Rheumatoid arthritis (RA) is characterized by heterogeneity in its clinical manifestations, pathological features and response to treatment. Clinical studies reveal that approximately 60% of RA a biologic as a predictor of individual treatment response after 3 months of treatment in RA patients. One of the determinants will be ex-vivo (un)stimulated and inhibited cytokine profiling, since this is in our view a promising candidate predictor and has not been investigated before
Objective: To investigate ex-vivo cytokine profiling and several other determinants (e.g. proteomics, genomics) before the start of treatment with abatacept, adalimumab, etanercept, rituximab and tocilizumab as a predictor of individual treatment response after 3 months of treatment in RA patients.
Study design: This is a prospective longitudinal prediction cohort study.
Study population: RA patients > 18 years, treated in the Sint Maartenskliniek (Nijmegen, The Netherlands), who are going to start with (or switch to) a biologic (including abatacept, adalimumab, etanercept, rituximab and tocilizumab) will be included in this study.
Method: At baseline (before start biologic), blood samples will be obtained from every patient. Ex-vivo cytokine profiling will be performed with specific cytokine-inducing stimuli, in the presence or absence of several concentrations of respectively abatacept, adalimumab, etanercept, rituximab and tocilizumab. Also, several other determinants (e.g. proteomics, genomics) will be investigated in the peripheral blood.
Main study endpoint: Primary outcome is the European League against Rheumatism (EULAR) good response criteria (DAS28CRP <3.2, and ∆DAS28CRP > 1.2 compared to baseline), 3 months after the start of treatment with one of the above biologics.

The objective of this study is to investigate ex-vivo cytokine profiling and several other determinants (e.g. proteomics, genomics) before the start of treatment with abatacept, adalimumab, etanercept, rituximab and tocilizumab as a predictor of individual treatment response after 3 months of treatment in RA patients.

Data will be recorded at baseline and after 3 and 6 months (+/- 1 month) of treatment with the biologic.

The day of the first biologic administration is appointed as baseline.

At baseline (before start biologic), blood samples will be obtained from every patient. During follow-up, all patients will receive usual care and tight control.

In usual care, trained nurses assess the disease activity (DAS28CRP) during the outpatient clinic visits every 3 months (+/- 1 month). With these data, individual treatment response (EULAR good response criteria) can be calculated after 3 and 6 months (+/- 1 month) of treatment with the biologic.