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THE IMPACT OF CROHN’S DISEASE (CD) AND TREATMENT WITH CERTOLIZUMAB PEGOL (CZP) 400MG EVERY 4 WEEKS ON PATIENT REPORTED HEALTH STATUS (PRHS): PRECISE 2

C Bernstein¹, B Feagan², A Cohen³, F Anderson⁴, DL Keininger^5
1University of Manitoba; ²University of Western Ontario; ³McGill University; ⁴Liver and Intestinal Research Center; 5UCB, Belgium

Purpose: We assessed the impact of CD and treatment with CZP on the PRHS in PRECiSE 2. This study¹ showed efficacy and tolerability for subcutaneous (sc) CZP in patients (pts) with a CDAI score of 220-450 points.
METHODS: After CZP 400mg sc induction at Weeks (Wks) 0, 2, 4, pts with a clinical response (CDAI score decrease =>100 points) at Wk 6 were randomized to CZP 400mg or placebo every 4 wks from Wk 8 to 24. PRHS was assessed using SF-36 and EQ-5D questionnaires at baseline, Wk 6, 16 and 26.
RESULTS: Baseline physical and mental health were lower for pts with CD than for those with IBS or GERD and the general population. Domains most affected were SF-36 Role Physical and EQ-5D Pain/Discomfort; least affected were SF-36 Physical Function and EQ-5D Self-Care. Following induction therapy, scores were similar to the general population: SF-36 domain scores improved by 17-45 points; SF-36 component summary scores by 10-11 points and EQ-5D VAS by 24 points (Table). CZP sustained improvements from Wk 6 to 26 at levels significantly greater than with placebo in all SF-36 domains except Physical Function, in the EQ-5D VAS score and in 3 out of 5 domains of EQ-5D (Table).
                                   

Mean score change  from baseline	Change from Week 0 to 6 with CZP Induction	Change from Week 0 to Week 26	Change from Week 0 to Week 26	Change from Week 0 to Week 26
	Placebo (n=210)	CZP (n=215)		p-value b
SF-36 MCS	10.5	8.1	9.5	0.001
SF-36 PCS	9.7	8.7	10.5	0.014
EQ-5D VAS	24.2	23.0	25.3	0.002

 M/PCS, mental/ physical component summary; VAS, visual analogue scale
CONCLUSIONS: At baseline, pts in PRECiSE 2 showed a markedly impaired PRHS. Following CZP therapy, PRHS rapidly improved and was similar to that in the general population. Pts receiving CZP sustained a significantly higher PRHS than those receiving placebo.
1Schreiber 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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