Safety and Efficacy of Certolizumab Pegol for Rheumatoid Arthritis

A 16-week, open-label extension of the REALISTIC phase 3b trial shows rapid and sustained clinical improvements with certolizumab pegol in patients with RA.

Results of the REALISTIC phase 3b study suggest that a diverse population of patients with rheumatoid arthritis (RA)  experienced rapid and sustained clinical improvement while taking a regimen of certolizumab pegol (CZP), according to research published in Arthritis Research and Therapy.

The 28-week REALISTIC phase 3b study was led by Michael E. Weinblatt, MD, Clinical Rheumatology Associate Director at the Center for Arthritis and Joint Diseases at Brigham and Women’s Hospital in Boston, Massachusetts.  The study included all patients who had completed the previous double-blind phase and were eligible to enter the open-label phase. A total of 995 patients, recruited from 230 centers in the United States and Canada, entered the open-label phase and each received CZP 200 mg every 2 weeks for 16 weeks.

At week 28, clinical improvements were seen both in patients receiving CZP through the trial duration (n = 771, 90.6%) and in patients who had received a placebo during the double-blind phase and then transitioned to CZP during the open-label phase (n = 184, 86.8%). The effect of CZP treatment was similar regardless of prior anti-tumor necrosis factor use, disease duration, and concomitant disease-modifying antirheumatic drug (DMARD) use.

ACR20 response rate for both groups was 59.7% vs 53.3%. ACR50 and ACR70 response rates were similar. From baseline, reduction of Disease Activity Score 28 (DAS28) erythrocyte sedimentation rate (ESR) <1.2, reduction of swollen joint count (SJC) <25%, or reduction of Clinical Disease Activity Index (CDAI) <10 by week 12 was association with a <9% chance of achieving low disease activity at week 28.

“[The] addition of CZP to current therapy for up to 28 weeks was associated with sustained improvements in disease activity and physical function,” reported Dr Weinblatt. “Sustained efficacy was observed across all subgroups of CZP patients.”

Dr Weinblatt and colleagues reported a similar safety profile to previous CZP trials; no new safety signals were identified.


Weinblatt ME, Gleischmann R, van Vollenhoven RF, et al. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015;17:325-338. doi: 10.1186/s13075-015-0841-9.