SAN DIEGO, CA—At the 2013 ACR/ARHP Annual Meeting, study authors presented that patients with active rheumatoid arthritis (RA) despite methotrexate (MTX), certolizumab pegol (CZP) + MTX maintained reduction in signs and symptoms through 5 years.

Results from the RAPID2 randomized, controlled trial showed that CZP + MTX every 2 weeks improved signs and symptoms of RA over 24 weeks. Previous reports published in Arthritis & Rheumatism showed long-term safety and efficacy of CZP + MTX over 3 years in the RAPID2 open-label extension (OLE).

Josef S. Smolen, MD, from Medical University of Vienna and Hietzing Hospital, Vienna, Austria, and his team reported on the final long-term safety and efficacy of CZP + MTX over 5 years.

Of the 492 treated patients from the RAPID2 trial, 342 were eligible to enter the open-label extension with CZP 400mg every 2 weeks (reduced to 200mg every 2 weeks after >6 months) + MTX. Adverse events were assessed at each visit following the first dose of CZP.  In addition, data regarding DAS28(ESR), HAQ-DI and ACR20/50/70 were analyzed up to Week 232 for “CZP Completers” (those who enrolled onto the open-label extension [N=342]) and “CZP ITT” population (all patients randomized to CZP in the randomized controlled trial [N=492]). 


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Change from baseline in modified Total Sharp Score (mTSS) and the percent of patients with radiographic non-progression (mTSS change from RCT baseline ≤0.5) were recorded up to Week 128 for CZP Completers. Dose reduction efficacy data was collected for all Week 24 CZP Completers who received CZP 400mg every 2 weeks + MTX for ≥6 months in the open-label extension, following a dose reduction to 200mg every 2 weeks over 132 weeks of CZP exposure.

A total of 215 patients remained after 232 weeks from baseline. The safety profile was consistent with prior reports and no new safety signals were identified.

Clinical improvements from the randomized controlled trial were maintained to Week 232 in CZP Completers and ITT Population (mean DAS28(ESR), 3.7 and 3.9; mean HAQ-DI, 0.96 and 1.06; ACR20/50/70, 68.4%/47.1%/25.1% and 65.9%/45.4%/24.2%), researchers concluded.

Also, radiographic progression in CZP-treated patients was minimal (mean mTSS change from baseline to Week 24: 0.62, from baseline to Week 128: 0.79). Clinical improvements were maintained in the dose reduction population (400mg to 200mg every 2 weeks + MTX; N=288) from the first CZP 200mg treatment (DAS28[ESR]=3.5) through 132 weeks of CZP 200mg every 2 weeks (DAS28[ESR]=3.6).

Dr. Smolen concluded that CZP + MTX showed a “favorable long-term risk-benefit ratio” in maintaining reduction of signs and symptoms in patients with active disease.