Tuesday, August 26, 2014

Update on sarilumab in rheumatoid arthritis

Yesterday we wrote on Sanofi's COMPARE study of sarilumab in rheumatoid arthritis.  We believe that this is an important study, comparing sarilumab to Enbrel in rheumatoid arthritis patients who have not responded sufficiently to Humira.  We feel that this is an important study, alongside TARGET which is comparing sarilumab to placebo in TNF-IR patients.  TARGET could support the use of sarilumab in this cohort, while COMPARE is important commercially, potentially helping Sanofi to establish sarilumab as a second line biologic.  Given the high cycling rate of biologics in rheumatoid arthritis, this represents a key objective

Based on a change in COMPARE status on clinicaltrials.gov we understood that the study had completed early, and formed the conclusion that this important data may be ready for submission along with Sanofi's overall regulatory dossier next year

Since writing it has come to our attention that although COMPARE is now listed as "ongoing, but not recruiting participants" on clinicaltrials.gov, Sanofi may not have followed convention in updating this entry.  Usually this statement infers that the target patient number has been reached.  In contrast if a study has been stopped early for commercial reason, slow enrollment, adverse events etc, then this would be specified.  The situation regarding this trial is fluid and the above analysis will be updated if anything changes

In the meantime please feel free to contact us (fiona.watts@leaddiscovery.co.uk) for further information on the above

News on sarilumab development is also now available through our monthly UpdatesPlus Rheumatoid Arthritis report


Post a Comment

<< Home