Atacicept

At the ACR 2011 in Chicago there had been a study by R.F. van Vollenhoven and colleagues: Arthritis Rheum 2011 Jul;63(7):1782-92. The phase II, randomized, placebo-controlled trial of atacicept looked at patients with rheumatoid arthritis and an inadequate response to methotrexate. The authors had to conclude: “The primary end point (ACR20-CRP response) was not met despite significant biologic effects of atacicept that were consistent with its proposed mechanism of action. Modest effects of atacicept were seen for some secondary efficacy end points. Treatment with atacicept raised no new safety concerns.”
Has atacicept shown new efficacy? Well let´s look at the data first. R.F. van Vollenhoven and colleagues presented a new study on atacicept, this time in combination with rituximab. It somehow shows the desperation to get the drug working. But the results have been sobering, as “addition of atacicept to rituximab was associated with an increased risk of events”.


[THU0090] SAFETY AND EFFICACY OF ATACICEPT IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS FROM THE ATACICEPT FOR REDUCTION OF SIGNS AND SYMPTOMS IN RHEUMATOID ARTHRITIS TRIAL (III)
R.F. van Vollenhoven1, S. Wax2, S. Copt3, P.P. Tak4. 1Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), The Karolinska Institute, Stockholm, Sweden; 2Rheumatology, EMD Serono Inc, Rockland, MA, United States; 3Biostatistics, Merck Serono SA, Geneva, Switzerland; 4Division of Clinical Immunology and Rheumatology, University of Amsterdam, Amsterdam, Netherlands
Conclusions: In this exploratory trial, addition of atacicept to rituximab was associated with an increased risk of events that could be hypersensitivity-related. There was no increase in the clinical response rate.


I think we should abandon the idea that atacicept is a new drug to treat rheumatoid arthritis.