UCB (UCBJF) recently reported positive data on Cimzia (certolizumab pegol) from a late-stage trial — REALISTIC — on patients suffering from rheumatoid arthritis (RA). The data were presented at the annual meeting of the European League Against Rheumatism (EULAR).

In the study, in which Cimzia was added to current therapy in a diverse group of RA patients, the ACR20 response rates were significantly higher in the Cimzia arm (51.1%) compared to placebo (25.9%) at week 12. 

The study data also demonstrated that compared to placebo, the addition of Cimzia to the current therapy resulted in meaningful improvements in fatigue (56.4% versus 46.2%), sleep problems (49.7% versus 42.5%), pain (59.0% versus 42.0%) and patient-assessed disease activity (PtGA) (59.5% versus 42.5%) at week 12.

We note that Cimzia is currently marketed as a treatment for moderate-to-severe Crohn’s disease (CD) in the US and Switzerland and RA in the US and European Union (EU).

UCB also announced its plans to initiate a study to evaluate the comparative effectiveness of Cimzia and Abbott Labs’ (ABT) Humira (adalimumab) in the treatment of moderate-to-severe RA. The 12-week study will enroll patients with moderate-to-severe RA who have either shown inadequate response to methotrexate (MTX) or who have not received anti-TNF treatment previously.

In the study, the patients will be randomized to Cimzia plus MTX or Humira plus MTX for 12 weeks. Thereafter, patients who respond will continue with the treatment over the long term (104 weeks), while non-responders will switch to the alternative treatment arm for 104 weeks.

Earlier in the month, UCB had reported positive data on Cimzia from post-hoc analyses of late-stage trials – RAPID 1 and RAPID 2.

RAPID 2 trial 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, patients’ global assessment of disease, physical function by HAQ, and HRQOL by SF-36 physical and mental component summary scores.

Results from the RAPID 1 trial 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.

We currently have a Zacks #3 Rank (short-term Hold rating) on UCB. We are pleased with the results of the REALISTIC study and view the comparative study between Cimzia and Humira as positive, given that Cimzia is one of the main revenue generators at UCB, and positive results from the comparative study will help boost the drug’s sales.

 
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