Certolizumab pegol as treatment for Crohnʼs disease in a community IBD practice

Abstract

Purpose: Certolizumab pegol (CZP) is a pegylated-conjugated Fab' agent againsttumor necrosis factor, approved for the treatment of moderate to severe Crohn'sdisease (CD). This single center community practice has retrospectively reviewed3 years of CZP use as standard of care therapy in patients presenting with moderateto severe CD, both in TNF naive and exposed patients. Methods: A retrospective chart review of patients with CD receiving inductionand maintenance CZP injections between 7/1/2008 and 6/30/2011 was performed.Demographic and baseline disease characteristics; steroid, narcotic andtobacco use; Harvey Bradshaw Index (HBI), and quality of life scores (SIBDQ) werestudied. Steroid elimination and endoscopic endpoints were evaluated whenavailable. 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 3doses of CZP injected at FDA approved dosing for induction and maintenancetherapy. 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 responderswere TNF exposed, with a baseline HBI of 8.5 (range 4-14) and SIBDQ of 34 (range24-42 ). After treatment, the average HBI fell to 1.9 (range 0-5) in the responsegroup with a increase in the average SIBDQ score to 60 (range 47-70). Steroid eliminationwas successful in 15 responders (83%) with endoscopic healing demonstratedin 10 of 11 patients (5 colonoscopies, 6 wireless capsule endoscopies). All10 patients in endoscopic remission were also in clinical remission with an averageHBI of 1. The non-responder group included 5 males, 7 females, with an averageage of 37 years and average disease duration of 9.7 years. Seven non-respondershad prior surgery, 4 were smokers, 2 used narcotics and 100% were on steroids atthe time of CZP initiation. 83% (n=10) of non-responders had prior TNF exposure.Steroid elimination occurred in one patient (8%) and endoscopic endpoints werenot obtained in any of the non-responders. Baseline HBI average for non-responderswas 7.9 (range 4-15) with HBI after treatment of 7.6 (range 2-10). The averageSIBDQ 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 overallremission rate of 50%, response rate of 60% with successful steroid eliminationdespite prior biologic exposure (61%). Endoscopic healing and clinical remissionwas demonstrated in addition to a clear reduction in disease activity andimprovement in quality of life.