Safety and efficacy of Adalimumab for the induction of remission in Crohnʼs Disease in a specialist nurse lead outpatient clinic: Preliminary data from a single centre prospective study

Abstract

INTRODUCTION: Adalimumab, a self administered, subcutaneous, fully human monoclonal antibody against TNF-alfa is effective in luminal and perianal fistulising Crohn's disease (CD) for induction and maintenance of remission. It demonstrated steroidsparing properties, the ability to reduce hospitalizations and improve quality of life, with a significant effect on the management of CD. AIMS & METHODS: Currently the drug is firstly administered under the supervision of a medical doctor expert in the management of CD with the consequent consumption of healthcare and patient's resources similar to intravenous biological drugs. Aim of the study was to assess whether a specialist nurse could manage a protocol for the induction therapy with Adalimumab without affecting safety and effectiveness. Twelve consecutive CD patients (10 previously treated with other anti TNF-alfa drugs) have been referred to the outpatient clinic for the induction protocol with Adalimumab (160/ 80/40 mg eow). At baseline and 4 weeks after the first drug administration the following scores and tests were evaluated: Harvey Bradshaw Index (HBI), Perianal Disease Activity Index (PDAI), Short Inflammatory Bowel Disease Quality of life (S-IBDQ), a Visual Analogical Scale for the joint pain (VAS), Faecal Lactoferrin (LF), C-reactive protein (CRP), Intestinal Permeability Test (L/M). Signs and symptoms at each administration and every 8 weeks during the follow-up together with all ADR were recorded to evaluate safety during the mean follow-up of 3 +/-1 months. RESULTS: 7/12 (58.3%) patients had a clinical amelioration: 4 achieved remission (HBI<5), 3 had a response (HBI reduced at least 3 points), 5 patients remained stable. The mean HBI diminished from moderate disease to remission (8.4+/-8.0 to 3.4 +/-2.9; p = 0.033), the mean S-IBDQ from 47 +/-11.1 to 53.6 +/-6.7 (p = 0.065) and the VAS for the joint pain from 4.6 +/-3.3 to 3.2 +/-2.7 (p = NS). In 3 patients with perianal disease the mean PDAI decreased from 1.5 +/-3.0 to 0.9 +/-1.5 (p = NS). Non-invasive biological markers of inflammation confirmed clinical data. No ADR were seen during the follow-up. Six pts reported minor injection related symptoms. CONCLUSION: A specialist nurse lead outpatient clinic proved to be an effective and safe environment for the administration of Adalimumab in CD patients with preliminary results similar to published clinical trials. This modality could be used to spare healthcare resources and reduce costs of anti TNF-alfa therapy.