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P510 Efficacy and safety of certolizumab pegol in an unselected Crohn's disease population: long-term data of the FACTS III survey

S.R. Vavricka1, G. Rogler2, A. Schoepfer3, F. Seibold4, J. Borovicka5, P. Frei6, C.N. Manser2, M. Scharl2, B. Misselwitz2, A. Straumann7, P. Michetti8, L. Biedermann on behalf of Swiss IBDnet *2

1Hospital Triemli, Gastroenterology & Hepatology, Zurich, Switzerland, 2University Hospital Zurich, Division of Gastroenterology & Hepatology, Zurich, Switzerland, 3University Hospital Lausanne, Division of Gastroenterology & Hepatology,, Lausanne, Switzerland, 4Spital Tiefenau, University Hospital Bern, Division of Gastroenterology & Hepatology, Bern, Switzerland, 5Canton Hospital St Gallen, Division of Gastroenterology & Hepatology, St. Gallen, Switzerland, 6Seespital Horgen, Gastroenterology & Hepatology, Horgen, Switzerland, 7Swiss Eosinophilic Esophagitis Research Network, Praxis Römerhof, Olten, Switzerland, 8Clinique La Source-Beaulieu, Crohn and Colitis Center, Lausanne, Switzerland

Background

In Europe Certolizumab pegol (CTZ) is approved for the treatment of Crohn's disease (CD) only in Switzerland. In view of the limited long-term data from pivotal registry trials we aimed to evaluate the efficacy and safety of CTZ in clinical long term practice in Switzerland.

Methods

In the FACTS III (First Approved Certolizumab Therapeutic Experience in Switzerland) phase IV multicenter practice-based patient cohort patients receiving CTZ were prospectively included all over Switzerland in (non-) academic hospitals and private practice.

Results

A total of 104 patients (52 male) were included with first CTZ dose between 11/2007 and 08/2013 with a currently ongoing follow-up of until present between 6 weeks up to 5 years (mean 67.5 weeks, CI 6-208) and baseline-characteristics as follows: mean age: 36.6 years; mean age at diagnosis: 29.4 years (Montreal A1: 8.7%, A2: 68.3%, A3: 20.2%, unknown 2.8%); disease localization L1: 13.5%, L2: 63.5%, L3: 22.1%, unknown: 1.9%; disease behavior B1: 25%, B2: 25%, B3: 47.1%, unknown: 3.9%; smokers: 33.7%; previous surgery: 44%; anti-TNF naïve: 22.1%; previously received IFX, ADA orb both: 28.8%, 1.9% and 46.2%, respectively.

During treatment with CTZ we observed a significant decrease of mean HBI from 8.4 at baseline to 6.1 (p=0.017), 6.1 (p=0.063), 5.4 (p=0.002), 5.1 (p=0.009), 4.5 (p<0.001) and 3 (p<0.001) at week 6,26,52,78,104 and 156, respectively, corresponding to significantly increased rates of clinical remission at these points in time (41.4%, 40.7%, 51.9%, 58.1%, 53.6%, 73.3%; for all p<0.01). In addition, we found a sustained HBI decrease also in week 208 and 260 with mean HBI 5.6 and 5.2, respectively (however no significant difference to baseline due to small sample size), corresponding to a remission rate of 42.9% and 50% .

Looking specifically at anti-TNF naïve, exposed, prior non-response and prior loss of response (LOR) we did not observe any differences in mean HBI during the whole period of CTZ treatment between these four groups of patients. However, at the end of induction (week 6), anti-TNF naïve patients with a mean HBI of 2.6 showed a significantly better response than anti-TNF experienced (6.8, p<0.01), those with prior LOR (7.1, p<0.01) or those with prior non-response (8.5, p<0.01) to anti-TNF.

In contrast to the published data regarding Adalimumab, we did not observe significant differences in mean HBI while on treatment between patients with these different intervals of disease duration (and also at baseline).

Conclusion

CTZ is an effective long-term treatment in CD, including patients with long disease duration, prior treatment with 1-2 anti-TNF agents or previous LOR and non-response, suggesting that - similar to UC - Europe could use a third anti-TNF agent in CD.