UCB, the Belgian bio-pharma company has fielded more data on Cimzia (certolizumab pegol) its pegylated biologic treatment that inhibits tumour necrosis factor (TNF), this time during the American Congress of Rheumatology (ACR) meeting held 4-8 November in Chicago, US.
Cimzia, originally developed in the UK by Celltech, has previously shown it can achieve rapid benefits in moderate to severe rheumatoid arthritis (RA) within the first 12 weeks it is prescribed, starting as early as week 1. New open-label data from one study (REALISTIC) shown for the first time at ACR shows that benefit is sustained in a broad spectrum of RA patients, including those who failed previous biologic and anti-TNF therapies, over 28 weeks.
A separate new post-hoc analysis of data from a double-blind study (RAPID 1) involving several hundred RA patients, shows an early response to Cimzia predicts a good result a year hence in terms of joint preservation.
Two double-blind, placebo-controlled phase III studies on Cimzia from Japan (J-RAPID and HIKARI), in patients unable to take, or failing to respond well to, methotrexate (MTX), found Cimzia used as monotherapy or with other concomitant disease-modifying anti-rheumatic drugs (DMARDs) also achieved rapid and sustained clinical responses in Japanese populations similar or better to those seen in trials in the rest of the world.
The data is timely since a session at ACR previewing updated evidence-based ACR recommendations said certizolumab pegol, along with two other biologic treatments would be added to recommendations for treating RA to be published in 2012.
The new post-hoc data from the RAPID 1 study shows the majority of Cimzia-treated RA patients 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 more established measures including DAS-28.)
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 as rated by progression of scores on the modified Total Sharp Score from baseline. Patients receiving Cimzia and MTX who had a good or moderate response at week 12 according to either RAPID 3 or EULAR criteria had the least visible joint damage at week 52, with those receiving only placebo and MTX faring worst.
The new data from UCB’s REALISTIC study of over 1000 RA patients more typical of those seen in everyday practice rather than rarefied clinical trial settings, analysed results of the 16-week open-label extension phase. In this phase all patients who completed treatment in the double blind phase went on to receive Cimzia 200mg every other week including 770 from the Cimzia arm and 184 of those who had previously received only placebo and other DMARDs. Patients also continued on other usual DMARD therapy if any.
Investigators said treatment with Cimzia was associated with consistent efficacy and improved physical function during the 28 weeks patients were observed, regardless of whether they had responded or failed any previous treatment including other biologics. Patients previously receiving placebo plus a DMARD who responded to Cimzia saw a fast clinical response when treated. Over 50% of patients overall were Cimzia responders – similar rates were observed in patients previously randomised to placebo – and around 20% of patients achieved complete remission after receiving Cimzia.
In J-RAPID a double-blind study of 316 Japanese patients with a known poor response to MTX, patients were randomised to either Cimzia 100mg, 200mg or 400mg + MTX or placebo + MTX and followed for 24 weeks. Investigators said patients receiving Cimzia at any dose level + MTX saw a significantly superior response, often apparent by week 1, sustained to 24 weeks compared to patients receiving placebo + MTX (P<0.001). More patients receiving placebo + MTX dropped out. In the other double-blind Japanese study, HIKARI, 230 patients unable to tolerate MTX were randomised to either Cimzia 200mg monotherapy or placebo. Patients also continued on DMARDs other than MTX if these had been prescribed at baseline. Highly significant differences favouring Cimzia were seen between the two treatment groups by week 12 and week 24 (p<0.001). 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, said investigators led by Professor Kazuhiko Yamamoto, Department of Allergy and Rheumatology, Graduate School of Medicine, University of Tokyo. Written by Olwen Glynn Owen