Belgium's UCB has presented data on Cimzia, which shows that the drug delivered rapid and consistent improvements in a broad range of rheumatoid arthritis patients after 12 weeks of treatment.
These improvements were seen regardless of whether or not patients had received prior tumour necrosis factor (TNF) inhibitors or whether or not they were receiving concomitant disease-modifying anti-rheumatic drugs (DMARDs) according to the latest analysis of the Phase IIIb REALISTIC trial presented at the European League Against Rheumatism meeting in London.
In previous studies of Cimzia (certolizumab pegol), patients populations have been largely homogenous, with the treatment used either as monotherapy or as add-on therapy to methotrexate in RA patients who have had no prior exposure to TNF inhibitors.
In the 1,063-patient REALISTIC trial, the main results for which were presented at the American College of Rheumatology meeting in November last year, ACR20 response rates at week 12 were 51.1% in the Cimzia group versus 25.9% for those on placebo. For the latest data, investigators undertook a subgroup analysis of REALISTIC to investigate whether there were differences in efficacy for Cimzia according to whether it was used in patients with and without prior TNF inhibitor use, and whether it was being used with or without concomitant DMARDS.
The results showed that for patients who had used prior TNF inhibitors the ACR20 response rate was 47.2% for those randomised to Cimzia versus 27.5% for those in the control group. For patients with no prior TNF inhibitor use, the ACR20 was 53.5% for Cimzia versus 25% for the control.
“Based on these ACR 20 responses we found no significant difference for patients with prior anti-TNF and no prior anti-TNF,” said Paul Emery, president of EULAR and a REALISTIC study investigator.
Head-to-head with Humira
The data came after UCB announced plans to launch the first industry sponsored anti-TNF head to head study. The trial will randomise patients to receive either Cimzia plus methotrexate or Abbott Laboratories blockbuster Humira (adalimumab) plus MTX for 12 weeks, after which patients who respond will continue on their treatment, while non-responders will switch.