UCB has presented impressive results from a series of studies on its rheumatoid arthritis biologic Cimzia at the American College of Rheumatology meeting in Chicago.
New post-hoc data from the RAPID 1 study shows the majority of RA patients treated with Cimzia (certolizumab pegol) achieved a good response by week 12 according to both defined EULAR criteria and to observations by RAPID 3, an easier assessment tool taking as little as 10 seconds where patients themselves report on their physical function, pain and general wellbeing. (The results of RAPID 3 testing have been validated by correlations with the much stricter DAS 28 test.)
Lead investigator Edward Keystone from Mount Sinai Hospital, Toronto, Canada, said patients with good results at week 12 were more likely to show reduced disease progression at week 52 compared to patients with poor responses. The responses at week 12, particularly as judged by EULAR criteria, were predictive of structural damage to joints seen on X-ray a year later.
Patients receiving Cimzia and methotrexate (MTX) who had a good response at week 12 had the least visible joint damage, with those receiving only placebo and MTX faring worst.
‘Real-life’ patients benefiting from Cimzia at 28 weeks
Also fresh data from UCB’s REALISTIC study of over 1,000 RA patients more typical of those seen in everyday practice rather than rarefied clinical trial settings, analysed results of the open-label extension phase. In this phase, patients who had previously received only placebo and other disease-modifying anti-rheumatoid arthritis drugs (DMARDs) were included as well as those who previously received Cimzia with or without other therapies.
Investigators said treatment with Cimzia was associated with consistent efficacy and improved physical function up to 28 weeks regardless of whether they had responded or failed any previous treatment. Patients previously receiving placebo plus a DMARD saw a fast clinical response when treated with Cimzia.
Japan studies
Meantime, two Phase III studies from Japan, in patients unable to take, or failing to respond to MTX, found Cimzia also achieved rapid and sustained clinical responses in Japanese populations similar or better to those seen in trials in the rest of the world.
In J-RAPID , a study of 316 Japanese patients with a known poor response to MTX were randomised to either Cimzia + MTX or placebo + MTX and followed for 24 weeks. Investigators said patients receiving Cimzia + MTX saw a significantly superior response, often apparent by week 1, sustained to 24 weeks compared to patients receiving placebo + MTX. More patients receiving placebo + MTX dropped out.
In the other study, HIKARI, 230 patients unable to tolerate MTX were randomised to either Cimzia or a DMARD other than MTX. Highly significant differences favouring Cimzia were seen between the two treatment groups by week 12 and week 24. Responses were seen as early as week 1 with most responses seen by week 4. Cimzia-treated patients also had improved physical function and experienced less progression of joint damage.
UCB’s vice president for US medical affairs, Kathleen Bos, said: “The new data presented at ACR demonstrate that patients treated with Cimzia experienced improvements in work and household productivity – two significant measures of a patient’s overall quality of life.”
