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Purpose

Certolizumab pegol (CZP) is a pegylated-conjugated Fab' agent against tumor necrosis factor, approved for the treatment of moderate to severe Crohn's disease (CD). This single center community practice has retrospectively reviewed 3 years of CZP use as standard of care therapy in patients presenting with moderate to severe CD, both in TNF naive and exposed patients.

Methods

A retrospective chart review of patients with CD receiving induction and maintenance CZP injections between 7/1/2008 and 6/30/2011 was performed. Demographic and baseline disease characteristics; steroid, narcotic and tobacco use; Harvey Bradshaw Index (HBI), and quality of life scores (SIBDQ) were studied. Steroid elimination and endoscopic endpoints were evaluated when available. Response was defined as a decrease in HBI of 3 points after induction. Remission was defined as a HBI score of < =3.

Results

During the review period, a total of 30 CD patients received at least 3 doses of CZP injected at FDA approved dosing for induction and maintenance therapy. Of the 30 evaluated, 60% (n=18) were responders, with 40% (n=12) being non-responders. Fifteen of the 18 responders (50 % of ITT population) achieved clinical remission. The response group included 7 males, 11 females, with average age of 39.4 years and average duration of disease of 7.5 years. Eight responders had prior surgery, 3 were smokers, 4 used narcotics and 17 (94%) were on steroids at the time of CZP initiation. Eleven (61%) of responders were TNF exposed, with a baseline HBI of 8.5 (range 4-14) and SIBDQ of 34 (range 24-42 ). After treatment, the average HBI fell to 1.9 (range 0-5) in the response group with a increase in the average SIBDQ score to 60 (range 47-70). Steroid elimination was successful in 15 responders (83%) with endoscopic healing demonstrated in 10 of 11 patients (5 colonoscopies, 6 wireless capsule endoscopies). All 10 patients in endoscopic remission were also in clinical remission with an average HBI of 1. The non-responder group included 5 males, 7 females, with an average age of 37 years and average disease duration of 9.7 years. Seven non-responders had prior surgery, 4 were smokers, 2 used narcotics and 100% were on steroids at the time of CZP initiation. 83% (n=10) of non-responders had prior TNF exposure. Steroid elimination occurred in one patient (8%) and endoscopic endpoints were not obtained in any of the non-responders. Baseline HBI average for non-responders was 7.9 (range 4-15) with HBI after treatment of 7.6 (range 2-10). The average SIBDQ score for non-responders at baseline was 37 (range 24-64)increasing to 44 (range 25-64) after treatment.

Conclusions

In our single center, retrospective study, CZP showed an overall remission rate of 50%, response rate of 60% with successful steroid elimination despite prior biologic exposure (61%). Endoscopic healing and clinical remission was demonstrated in addition to a clear reduction in disease activity and improvement in quality of life.

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Clinical Poster Presentations
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Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.
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