After 12 weeks of treatment certolizumab pegol (Cimzia ®) delivered rapid and consistent improvements in a broad range of rheumatoid arthritis (RA) patients regardless of whether or not they had received prior TNF inhibitors, concluded the latest analysis of the Phase III b REALISTIC trial. The study, presented at the European League Against Rheumatism (EULAR) meeting in London, May 25-28, also showed that the same result could be achieved regardless of whether or not RA patients had received concomitant DMARDs.

“These results are encouraging because they demonstrate the clinical usefulness of certolizumab pegol in a broad population of patients with RA and reflect the patient variability we see day-to-day in clinical practice,” said Roy Fleischmann, one of the investigators of the study from the Department of Internal Medicine at the University of Texas Southwestern Medical School (Dallas, Texas).

In previous studies of 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 REALISTIC (RA Evaluation in Subjects Receiving TNF Inhibitor Certolizumab Pegol) trial,1,063 patients were randomized 4:1 to CZP (n=851) or control (n=212). Patients, who were recruited from North American and Western Europe, had active RA at screening and baseline defined by >5 tender joints, >4 swollen joints and C-reactive protein levels >10mg/ and or erythrocyte sedimentation rates >28 mm/hour. The main results of the REALISTIC study, presented at the American College of Rheumatology meeting 2010, showed that ACR20 response rates at week 12 were 51.1% in the certolizumab pegol group versus 25.9% in the placebo group (p

Furthermore, in a post hoc analysis investigators found no significant difference in ACR20 results regardless of whether patients received monotherapy or one concomitant DMARD or two concomitant DMARDs.

A second abstract study (EULAR 11-6261) showed that Week 12 ACR20 responses were similar in CZP patients regardless of whether they had discontinued prior TNF inhibitors for lack of efficacy or due to intolerance (49.7% versus 52.6%) and also that ACR20 rates were similar regardless of the number of prior TNF inhibitors patients had received – with 46.7% of patients who had one prior treatment achieving ACR20 versus 48.3% who had two prior treatments.

“The study is good news for patients with RA because regardless of their prior treatment history they stand a similar chance of responding to certolizumab pegol,” added Emery.

UCB has just announced (25 May,2011)that it will be undertaking the first industry sponsored anti TNF head to head study of certolizumab pegol plus methotrexate (MTX) versus adalimumab plus MTX.

Reference
Weinblatt M et al. Certolizumab pegol as monotherapy or with concomitant DMARDs in patients with active rheumatoid arthritis (RA) with or without prior TNF inhibitor use: analyses of the REALISTIC 12-week Phase IIIb randomised controlled study. Poster presented at the EULAR Annual European Congress of Rheumatology; 2011, 25-28 May; London, UK. FRI0214

Written by Janet Fricker