“The various clinical trials with tofacitinib that provided the clinical trial evidence to allow it to become the first JAK SMI to be approved by the US-FDA and European Medical Agency (EMA) for the therapy of RA did not routinely compare human body fluids, such as sera or synovial fluid, for decreased biomarkers (e.g., pro-inflammatory cytokines, TNF-alpha, IL-6, IL-17, IL-1-beta, MMP-3/MMP-9), which should be decreased by JAK SMIs,” he said. “Perhaps in the rush to obtain approval of new JAK SMIs such as upadacitinib, these additional determinations would take time and increased effort. Nevertheless, in my opinion, it is quite important to show that some or all of the pertinent biomarkers of RA disease activity are, in fact, decreased by the JAK SMIs.”
AbbVie Inc. sponsored the trial, employed five of the 12 authors, and had various relationships with the other seven authors.
Dr. Smolen did not respond to a request for comments.
- Smolen JS, Pangan AL, Emery P, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019 May 23. [Epub ahead of print]