Area Editoriale
Forte messaggio emergente da questo trial controllato moncentrico condotto a Lovanio: nel 28 per cento dei pazienti passati da infliximab ad adalimumab (contro solo il 2 per cento dei pazienti che hanno proseguito l'infliximab) si è resa necessaria la sospensione della terapia, nella maggior parte dei casi per intolleranza. Inotre nella metà dei pazienti in cui è stata ripresa la terapia con infliximab si è resa necessaria una intensificazione del regime terapeutico incremento di dosaggio. Da notare soltanto che in tutti i pazienti l'induzione è stata effettuata con il dosaggio 40/80, per cui non si può teoricamente escludere che i risultati possano essere diversi utilizzando il dosaggio maggiore
Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial. Van Assche G, Vermeire S, Ballet V, Gabriels F, Noman M, D'Haens G, Claessens C, Humblet E, Vande Casteele N, Gils A, Rutgeerts P. Gut. 2012;61:229-34
Background Elective switching between anti-tumour necrosis factor (TNF) agents not necessarily dictated by efficacy or tolerability occurs in clinical practice. A study was undertaken to evaluate prospectively the impact of elective switching of patients with Crohn's disease well controlled with intravenous infliximab to subcutaneous adalimumab in a controlled trial. Methods An open-label randomised single-centre trial recruited 73 patients with ongoing response to at least 6 months of scheduled maintenance infliximab. Patients were randomised to continue intravenous 5 mg/kg infliximab or to switch to subcutaneous adalimumab 80 mg at baseline followed by 40 mg every other week for 1 year. Dose optimisation was allowed for intermittent flares, and patients with loss of response or intolerance could cross over to the alternative treatment group. Tolerability, patient preference and efficacy of both treatment options were the primary outcomes. Results Dose optimisation or interruption of treatment occurred in 17/36 patients (47%) in the adalimumab group and in 6/37 patients (16%) in the infliximab group (p=0.006). One patient interrupted infliximab treatment and 10 patients interrupted adalimumab treatment (p=0.003), mostly for loss of tolerance. Overall, patients preferred adalimumab treatment. All five serious adverse events were related to complicated Crohn's disease and occurred in patients randomised to adalimumab. Injection site reactions were more frequent than infusion reactions (8 vs 1, p=0.01), but only the latter caused cessation of further dosing. Anti-TNF serum levels were stable throughout the 1-year period in
both groups. Conclusion Elective switching from infliximab to adalimumab is associated with loss of tolerance and loss of efficacy within 1 year. Adherence to the first anti-TNF agent is recommended.