Table 4.

Certolizumab in Crohn’s disease

Study	Number of patients	Duration of treatment	Comparisons	Primary end-point	Response to treatment
Schreiber118 PRECiSE 2 subpopulation	CZP n = 28 Fistulizing disease Placebo n = 30	26 weeks	CZP vs placebo	closure of fistula	36% vs 17% (P = 0.038)
Schoepfer117	n = 50	6 weeks	CZP 400 mg sc at weeks 0, 2, and 4	Response and remission rates	Response = 54% Remission = 40% Effectiveness in fistulizing disease
Schreiber112	n = 428	26 weeks	Induction therapy, 400 mg CZP at weeks 0, 2, and 4. Patients with clinical response received 400 mg CZP or placebo/4 weeks through week 24	Maintenance of response through week 26. Baseline CRP > 10 mg/L	Response was maintained through week 26 in 62% of CZP vs 34% of placebo, P < 0.001) Among patients with response to induction therapy remission at week 26 was seen in 48% of CZP vs 29% of placebo (P < 0.001).
Sandborn111	n = 662		Patients were stratified according to baseline CRP. Treatment: either 400 mg of CZP or placebo at weeks 0, 2, and 4 and then every 4 weeks		Patients with CRP >10 mg: 37% in CZP group had response at week 6, vs 26% in the placebo group (P = 0.04). At weeks 6 and 26, the corresponding values were 22% and 12% (P = 0.05). Overall, response rates at week 6: 35% in CZP vs 27% in placebo (P = 0.02)

Abbreviations: CRP, C-reactive protein; CZP, certolizumab pegol.