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Similar Outcomes Seen With Certolizumab, MTX vs Adalimumab, MTX
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WASHINGTON — The first head-to-head comparison of two tumor necrosis factor inhibitors, certolizumab and adalimumab, both administered with methotrexate showed the treatments yielded nearly identical responses, according to findings presented at the American College of Rheumatology Annual Meeting.
Roy Fleischmann, MD, of the University of Texas Southwestern Medical Center at Dallas Metroplex Clinical Research Center, said that no head-to-head trial of biologic disease-modified antirheumatic drugs within the same class, including tumor necrosis factor (TNF) inhibitors, had previously been undertaken. The current 2-year superiority study was double-blinded for the first 12 weeks and then investigator-blinded through week 104.
The analysis included 457 patients initially randomized to certolizumab (Cimzia, UCB) on weeks 0 and 2 with methotrexate (MTX) and 458 patients assigned adalimumab (Humira, AbbVie) 40 mg every 2 weeks plus MTX. There were 400-mg and a 200-mg certolizumab arms. At week 12, patients were classified as responders or non-responders. Response was defined as having a disease activity score 28 erythrocyte sedimentation rate DAS28(ESR) of equal to or less than 3.2 or a DAS28(ESR) reduction from baseline of at least 1.2. Patients who failed to respond were switched to the other therapy.
“If patients showed no response to both drugs, they were discontinued from the study,” Fleishmann said.
The proportion of patients who achieved ACR20 at week 12 served as the primary endpoint, along with low disease activity at week 104, which researchers defined as DAS28(ESR) less than or equal to 3.2. The researchers also assessed response at several intermediary times, along with secondary endpoints that included the ACR50/70.
“[Here] is our conclusion: Both drugs were equal,” Fleishmann said. “There was no difference in ACR 20, 50 or 70, no difference in low disease activity. They were all the same. These data refute the popular misconception that when a patient fails to respond to a first TNF inhibitor, they will respond to a second.”
At week 12, the response rate to certolizumab was 78.8% compared with 80.3% for adalimumab. There was no statistically significant difference between ACR20 rates for the two drugs at this point.
Moreover, 60% of primary non-responders to either certolizumab or adalimumab at week 12 did not achieve a DAS28 response when switched to the alternative TNF inhibitor, according to Fleishmann. Regarding safety, he noted there were no differences between the two drugs during the 104-week study.
“We have shown in a head-to-head setting that there is no statistical difference between certolizumab and adalimumab in combination with methotrexate at 12 weeks or through week 104,” Fleishmann concluded. “These findings emphasize the importance of clinical decision-making at week 12. If you are treating patients with a TNF inhibitor and at 12 weeks the patient does not show an adequate response, by ACR guidelines or EULAR recommendations, you should change therapy. What we are suggesting is that it could be any change, to another TNF inhibitor, or to a drug with another mechanism.” – by Rob Volansky
Reference:
Fleischmann R, et al. Abstract #2987. Presented at: The American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosure: Fleischmann reports associations with Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Genentech, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis and UCB Pharma.