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P340 Adalimumab treatment in Ulcerative Colitis patients who are naïve to anti-TNF: Week 8 of our pilot study

C. Muñoz Villafranca*1, R. Higuera2, O. Merino3, Ó. Nantes4, P. Ramirez de la Piscina5, A. Munagorri6, C. Rodriguez4, P. Arreba7, M.A. Ogueta8, J.A. Arévalo9, A. Bernal9, L. Gómez3, S. Ibañez10, J. Ortiz de Zárate11, J.L. Cabriada9

1Hospital Universitario de Basurto, Aparato Digestivo, Bilbao, Spain, 2Hospital San Eloy, Gastroenterlogy, Baracaldo, Spain, 3Hospital Universitario de Cruces, Gastroenterology, Baracaldo, Spain, 4Hospital de Navarra, Gastroenterology, Pamplona, Spain, 5Hospital de Txagorritxu, Gastroenterology, Vitoria, Spain, 6Hospital Donostia, Gastroenterology, Donosti, Spain, 7Hospital Universitario de Basurto, Gastroenterology, Bilbao, Spain, 8Hospital de Santiago, Gastroenterology, Vitoria, Spain, 9Hospital de Galdácano, Gastroenterology, Galdácano, Spain, 10Hospital universitario de Cruces, Gastroenterology, Baracaldo, Spain, 11Hospital Universitario de Basurto, Gastroenterology, Bilbao, Spain

Background

Adalimumab has proved its efficacy in Ulcerative Colitis (UC) treatment in controlled studies. Nevertheless, we have little information on the response of adalimumab in clinical practice.

Aim: Learn the response to Adalimumab treatment in UC patients and the related factors.

Methods

We carried out a multicentric, prospective and observational study in steriod-resistant and steroid-dependant UC patients who were naïve to anti-TNF treatments. They were treated with Adalimumab at a dosis: 160, 80, 40 mg on weeks 0, 2, 4 and every two weeks, with weekly dose intensification according to the clinician's judgement. We performed an endoscopic study at weeks 0 and 8 that was assessed by Mayo endoscopic scoring system from 0 to 3. We assessed clinical response at weeks 4 and 8. The clinical activity at weeks 0 and 8 was determined with Mayo scoring index (0-12) and at week 4 with Mayo subindex (0-9).

We defined clinical remission (CR) as a Mayo score <2; clinical response as a drop of at least 3 points in this score; and Mucosa Healing (MH) as a subscore of 0-1. The analysis of the Results was performed with intention-to-treat (ITT) (it includes all the patients that had received at least one dose of adalimumab)

Statistical analysis was performed with SPSS 20, using the Chi-square test for univariate analysis and for the multivariate analysis a logistic regression was performed.

Results

Of the 24 patients enrolled in this study, 22 completed the 8 weeks (2 were pulled out because of clinical worsening). UC was severe in 4 (16.7%) , moderate in 19 (79.2%) and mild in 1 patient (4.2%). 5 of them (20.83%) were hospitalized and more than half, 14 (58.33%), were steroid-dependant. Clinical remission was achieved, at weeks 4 and 8, in 8 (33.3%) and 11 patients (45.8%), and clinical response in 11 (45.8%) and 8 (33.3%), respectively. At week 8 of the study, only 1 patient was hospitalized and none suffered a colectomy. Mucosal healing (MH) at week 8 was achieved in 15 cases (78.9%), and a correlation was found with remission (p<0.025) and clinical response (p<0.028). Among the response factors at week 8, we found a relationship between the absence of blood in the stool, clinical response (p<0.014) and clinical remission (p<0.001) and between the calprotectine stool levels and Clinical Remission (p<0.019).

Conclusion

1.-Adalimumab is an effective treatment in the induction of clinical response in patients with ulcerative colitis.

2.-Adalimumab is an effective therapy in the induction of early mucosal healing in these patients. There is a relationship between clinical activity and mucosal healing.