CIMZIA Provides Long-Term Benefit In Crohn's Disease Patients
Data from two studies presented this week by UCB at the American College of Gastroenterology (ACG) Annual Meeting demonstrate that CIMZIA (certolizumab pegol) - the only PEGylated anti-TNF alpha (Tumor Necrosis Factor alpha) - provides sustained improvement in symptoms with stable dosing for adult patients suffering from moderate to severe Crohn's disease (CD). A third study presented by UCB provided an estimated comparison of treatment costs and found that CIMZIA offers a cost savings versus other commonly-used biologics.
An analysis of the PRECiSE 3 open-label extension study data showed that after 2.5 years (30 months) of treatment with CIMZIA, 72 percent of patients were in remission based upon responder analysis. These clinical trial data will be presented by William Sandborn, M.D., of the Mayo Clinic in Rochester, Minn., a study investigator. Previously, UCB had reported remission data up to 18 months.
Furthermore, data from the WELCOME study showed that 39 percent of patients who responded to CIMZIA treatment after failing infliximab therapy achieved clinical remission within six weeks. Additionally, there were no differences in clinical response rates regardless of the reason for infliximab failure, and irrespective of treatment as a monotherapy or in combination with other common Crohn's disease medications.
CIMZIA, manufactured by UCB, was approved by the U.S. Food and Drug Administration on April 22, 2008 for reducing signs and symptoms of moderate to severe Crohn's disease and maintaining clinical response in adult patients who have had an inadequate response to conventional therapy. The approval was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn's disease.
WELCOME Study (Abstract #P283)
Data from the Phase IIIb WELCOME study showed that 39 percent of patients who responded to CIMZIA treatment after failing infliximab therapy achieved clinical remission at Week 6 as measured by the Crohn's Disease Activity Index (CDAI). In addition, the study found that 61 percent of study patients reduced CDAI symptom scores by 100 points and 68 percent reduced CDAI scores by 70 points. The CDAI is a patient/physician questionnaire which incorporates eight CD-related variables. Scores of <150 indicate remission, and scores of >450 indicate severe illness along the 600 point scale.
Response to CIMZIA was similar when used as a monotherapy or with concomitant corticosteroids or immunosuppressants. There were also no differences in clinical responses to CIMZIA among those patients who had previously lost response to infliximab (62 percent), were hypersensitive to infliximab (61 percent) or both (58 percent).
PRECiSE 3 Study (Abstract #P280)
The PRECiSE 3 (P3) open-label extension study of PRECiSE 1 and PRECiSE 2 was designed to evaluate the longer-term safety and effectiveness of CIMZIA in patients completing the other two studies. The 30-month analysis includes data from 141 patients who have been continuously treated with CIMZIA for 2.5 years. At the beginning of P3, 73 percent of CIMZIA-treated patients were in remission. After 2.5 years (30 months) of treatment with CIMZIA, 72 percent of patients were in remission based upon responder analysis. The incidence of injection site pain was low in the CIMZIA group, and no new safety signals observed over 2.5 years of active treatment.
Pharmacoeconomics Study (Abstract #P277)
A cost analysis for induction and maintenance dosing regimens for CIMZIA, infliximab and adalimumab was estimated for a 65kg patient over a two-year period. Response and remission rates were assumed the same between treatments, and maintenance therapy was followed if responding to initial therapy and continued in year 2 for remitters. Based on average wholesale prices for the treatments, estimate of treatment costs showed that CIMZIA provided more cost savings during induction and maintenance phases of treatment when compared to infliximab and adalimumab.
A cohort budget analysis, with uptakes of 60 percent, 30 percent and 10 percent in year 1 and 50 percent, 30 percent and 20 percent in year 2 for infliximab, adalimumab and CIMZIA, respectively, was performed for a healthcare plan of 5 million members with a CD prevalence of 162 per 100,000 and incidence rate of 9.6 per 100,000. Results showed that access to CIMZIA provided a savings of more than $1.5 million compared to a healthcare plan that did not include CIMZIA. The data suggest that based on standard regimens for each of the TNF alpha blockers for CD, CIMZIA may be less costly than the two biologics studied.
The WELCOME study is a 539 patient Phase IIIb multicenter 26-Week trial Evaluating the clinical benefit and tolerability of certoLizumab pegol induCtiOn and Maintenance in patients suffering from Crohn's disease with prior loss of response or intolErance to infliximab. It consists of an open-label induction phase (400 mg of CIMZIA sub-cutaneously at Weeks 0, 2 and 4) and a double-blind maintenance period (400 mg of CIMZIA every 2 or 4 weeks from Week 6). The primary endpoint was defined as the rate of response (defined as a decrease in CDAI score less than or equal to 100 points from baseline) at Week 6. Remission was defined as a CDAI score of greater than or equal to 150 points. After the induction period, 62 percent of patients achieved response and 39 percent achieved remission. One-third of patients had responded to treatment by Week 2 (33 percent) and more than forty percent (44 percent) had responded by Week 4.
About the PRECiSE Clinical Trial Program
PRECiSE, one of the largest, most comprehensive development programs for an anti-TNF for Crohn's disease is composed of two placebo-controlled studies and two open-label safety follow-up studies. In 2007, the two former studies were published in the New England Journal of Medicine (NEJM). The studies demonstrated that patients with moderate to severe Crohn's disease achieved and sustained clinical response with CIMZIA for up to six months, compared to placebo. The safety and tolerability of CIMZIA was consistent with that expected of an anti-TNF agent. In the first follow-up study, patients completing both initial studies are to be given CIMZIA every four weeks for up to seven years. In the second follow-up study, patients who relapsed in either initial study (defined as an increase in CDAI of >70 or absolute CDAI of >350) were re-introduced to CIMZIA every four weeks to be continued for up to seven years, with a single additional dose at week 2.