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RAPID ONSET OF RESPONSE AND REMISSION TO SUBCUTANEOUS (SC) CERTOLIZUMAB PEGOL (CZP) AND LACK OF INFLUENCE OF CONCOMITANT BASELINE MEDICATIONS IN ACTIVE CROHN’S DISEASE (CD): OPEN-LABEL INDUCTION PHASE OF PRECISE 2

M Khaliq-Kareemi¹, R Enns², A Cohen³, OO Thomsen^4
1Department of Medicine, University of Calgary; ²St Paul’s Hospital, University of British Columbia; ³Jewish General Hospital, McGill University; ⁴Gastroenterology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark

OBJECTIVE: To assess the rate of induction of response and remission during the initial open-label phase of the PRECiSE 2 study, which was a Phase 3 study designed to determine the efficacy and tolerability of CZP, a PEGylated Fc-free anti-TNF molecule with high potency for human TNFalpha.¹
AIMS AND METHODS: PRECiSE 2 was a multicenter, randomized, double-blind, 26-week trial of patients with moderate-to-severe CD (CD Activity Index [CDAI] 220-450 points) who responded to induction therapy. In the 6-week induction period, 668 pts received open-label CZP 400mg at Weeks 0, 2, 4. CDAI score was recorded at each visit. Two definitions of clinical response (CR) were analyzed: a decrease in CDAI score of =>100 points (CR100) and a decrease of =>70 points (CR70). Remission was defined as a CDAI score of <=150 points. CR100 and remission rates stratified by concomitant immunosuppressant (IS) or corticosteroid (CS) use were also determined.
RESULTS: Of the 428/668 (64.1%) pts responding at Week 6, 52% (CR100) and 72% (CR70) were already responders by Week 2, and 42% of pts who were in remission at Week 6 had achieved remission by Week 2 (Table). Most pts had achieved a response by Week 4. Week 6 CR100 rates were similar in pts with or without concomitant CS (62.9% vs 64.8%) or IS use (66.3% vs 62.7%). Remission rates did not differ substantially between subgroups.
                        

	CR70 (%)	CR100 (%)	Remission (%)
Week 2 (n=655)	47.4	33.3	18.0
Week 4 (n=665)	62.1	49.7	31.0
Week 6 (n=668)	66.4	64.1	43.3

CONCLUSIONS: A rapid response to CZP was achieved by many pts after the first dose during open-label treatment. Response and remission rates at Week 6 were unaffected by concomitant CS or IS use.
1. Schreiber S, et al. N Engl J Med 2007;357:239-250.
This research was funded by UCB S.A., Braine L’Alleud, Belgium

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