UCB (UCBJF) recently reported positive data on Cimzia (certolizumab pegol) from a post-hoc analysis of a late-stage trial – RAPID 2. The results were published in the Annals of Rheumatic Diseases.
We note that Cimzia is currently marketed as a treatment for moderate-to-severe Crohn's disease (CD) in the US and Switzerland and rheumatoid arthritis (RA) in the US and European Union (EU).
The RAPID 2 study enrolled patients with active RA who showed inadequate responses to methotrexate (MTX) therapy. Patients were randomized to receive Cimzia (400 mg at weeks 0, 2 and 4 followed by 200 mg or 400 mg every two weeks) plus MTX, or placebo together with MTX for 24 weeks.
The data demonstrated that at week 24, a larger number of patients in the Cimzia arm experienced improvements in all six Patient Related Outcomes (PROs) as compared to the placebo arm. Patients in both the 200 mg and 400 mg treatment groups experienced similar benefits with no significant difference.
The six PROs include pain, fatigue, patient's global assessment of disease (PtGA), physical function by HAQ, and HRQOL by SF-36 physical and mental component summary scores.
Moreover, at week 24, 63% of patients treated with Cimzia 200 mg reported clinically meaningful improvements in at least 1 PRO compared to 13% in the placebo arm. Also, about 23% of all the patients treated with Cimzia reported clinically meaningful improvements in all six PROs compared to 3% in the placebo group.
Earlier in the month, UCB had reported positive data from a post-hoc analysis of another late stage trial of Cimzia – RAPID 1. These results were published in the Journal of Rheumatology.
UCB conducted the RAPID 1 trial to establish the efficacy and tolerability of Cimzia when dosed in combination with MTX for the treatment of patients with moderate to severely active RA, who did not adequately respond to conventional treatment.
The results demonstrated that at weeks 6 and 12 of treatment, rapid response rates were achieved among patients treated with Cimzia compared to those in the placebo arm.
Our Take
We currently have a Zacks #3 Rank (short-term Hold rating) on UCB. We are pleased with the results of the post-hoc analyses studies of Cimzia, as the drug is one of the main revenue generators at UCB.
However, we note that UCB faced a setback in March when the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended against the approval of Xyrem for the treatment of fibromyalgia syndrome in adults.
Xyrem is already marketed in the EU for the treatment of narcolepsy with cataplexy in adults. UCB markets the drug in the EU under a license from Jazz Pharmaceuticals Inc. (JAZZ).
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