Date: 2015-12-08
Type of information: Presentation of results at a congress
phase: 4
Announcement: presentation of results the Annual Meeting of the American College of Rheumatology (ACR)
Company: University Hospital, Strasbourg (France)
Product: monitoring biotherapies
Action mechanism:
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country: France, Monaco
Trial
details: Approximately 30% of patients with rheumatoid arthritis have an inadequate response to anti-TNF (primarily or loss of response), leaving two alternatives: rotation to a second anti-TNF or change of biologic, with a different mechanism of action, such as abatacept, rituximab and tocilizumab. No controlled trial compared these two strategies face to face. The present objective is to investigate the issue whether one of these strategies could have a better efficacy in a pragmatic trial in the setting of current practice. The ROC trial is a multicenter,investigator-initiated, open, parallel-group, randomized controlled trial. Patients with inadequate response to a first anti-TNF were randomly assigned in a 1:1 ratio to receive a non-TNF-targeted biologic (abatacept, rituximab or tocilizumab) or a second anti-TNF agent. Anti-TNF drug concentration in serum was measured using solid phase ELISA assays based on the capture of infliximab, adalimumab, golimumab, certolizumab with plate-bound recombinant TNF-a. For infliximab and adalimumab, the detection of anti-drug antibodies (ADAb) was performed by a homemade assay based on the ability of anti-idiotypic antibodies to neutralize anti-TNF drug activity and inhibit its capture by TNF-alpha (Candon S, et al. 2006). For the other anti-TNF, commercial tests were used. (Shikari, Eurobio for anti-etanercept ADAs, Lisa-Tracker kits (Theradiag, France) for anti-golimumab and anti-certolizumab ADAs). (NCT01000441)
Latest
news: * On December 8, 2015, Theradiag announced that the latest results of the ROC trial (Rotation of anti-TNF Or Change of class of biologic), presented to the Annual Meeting of the American College of Rheumatology (ACR), demonstrate the interest of monitoring biotherapies in patients with a loss of response to guide the choice of a second line of treatment. The ROC trial was interpreted taking the DAS28 index into account. These latest results confirmed that the dosage of anti-drug antibodies helps to guide the choice of a second line of biotherapy and thus gain a better response to the second treatment based on each patient’s profile. In addition, these results confirm the algorithms presented for patients with a loss of response, whether or not they have been immunised.
