Certolizumab pegol (Cimzia ®) delivered rapid and consistent improvements in a broad range of rheumatoid arthritis (RA) patients after 12 weeks of treatment regardless of whether or not they had received prior TNF inhibitors or whether or not they were receiving concomitant DMARDs, concluded the latest analysis of the Phase III b REALISTIC trial presented at the European League Against Rheumatism (EULAR) meeting in London, May 25-28 (abstract FRI021).
“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 from the Department of Internal Medicine at the University of Texas Southwestern Medical School.
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<0.001).
In the current abstract investigators undertook a subgroup analysis of the REALISTIC data to investigate whether there were differences in efficacy for certolizumab pegol 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.
Results showed that for patients who had used prior TNF inhibitors the ACR 20 response rate was 47.2% for those randomized to certolizumab pegol versus 27.5% for those randomized to the control group (P<0.01). For patients with no prior TNF inhibitor use the ACR20 was 53.5% for those randomized to certolizumab pegol versus 25% for those randomized to the control group (P<0.0001).
“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, from Leeds Teaching Hospital (Leeds, England), president of EULAR, who was also a REALISTIC study investigator.
Furthermore, in the 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.
UCB has announced its plan (25 May) to launch the first industry sponsored anti TNF head to head study. The study will randomize patients to receive either certolizumab pegol plus methotrexate (MTX) or adalimumab plus MTX for 12 weeks, after which patients who respond will continue on their treatment, while nonresponders will switch.
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
Last updated on: 31/05/2011 10:21:39
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