UCB today announced the start of the EXXELERATE™ study which will evaluate the short- and long-term efficacy of Cimzia® (certolizumab pegol) plus methotrexate (MTX) compared with that of Humira® (adalimumab) plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). The start of this study confirms previously announced plans.
"This head-to-head study is an important milestone. We believe that EXXELERATE™ should help to provide additional evidence to support early, informed management decisions for people living with this chronic, progressive disease," said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.
The primary objectives of the study are to compare the relative efficacy of the two anti-TNF therapies during short- and long-term treatment (12 and 104 weeks, respectively).
"While meta-analyses from placebo controlled trials suggest differences in efficacy among anti-TNFs in RA, results from the EXXELERATE™ study should help to provide additional insights to support the current lack of head-to-head data and to guide treatment decisions," said Roy Fleischmann, MD, Clinical Professor of Medicine, The University of Texas South Western Medical Center, Dallas, Texas, US. "As recent guidelines on biological agents recommend rapid treatment to target for RA patients, it is also timely for EXXELERATE™ to explore the comparative long term benefits of anti-TNF therapies, related to early response-driven treatment decisions."
The European League Against Rheumatism (EULAR) and the international Treat-to-Target Expert Committee recommend appropriate therapeutic adaptation of disease-modifying anti-rheumatic drugs to reach targets of remission or low disease activity within three to six months of starting treatment.
Persistent active disease is a predisposing factor of subsequent disease severity, such as progressive joint damage, irreversible disability and increased mortality. Therefore, stopping inflammation rapidly can be an important therapeutic goal and studies have shown that achieving control of disease activity, ideally rapid control, has led to improved long-term outcomes for patients with RA.
EXXELERATE™ is a multi-center, single-blind, randomized, parallel-group study which will randomize patients to either certolizumab pegol plus MTX or adalimumab plus MTX. After 12 weeks, patients who respond will continue their initial treatment, whereas non-responders will switch to the alternative treatment arm until study end at 104 weeks. By including a week 12 response-based therapeutic decision, EXXELERATE™ aims to assess the impact of early response-driven treatment on long-term (104 weeks) clinical and patient outcomes. The study aims to enroll approximately 900 adult patients with moderate to severe RA in multiple geographies including the US, Canada and Europe, who have inadequately responded to MTX and who have not previously received anti-TNF treatment. The headline results from the study are expected in 2016.