P315. Acute infusional reactions to infliximab in an IBD day care centre

E. Martin Arranz1, M.D. Martin Arranz1, M. Jaquotot Herranz1, L. Casanova Martínez1, S. Gómez Senent1, J. Poza Cordon1, J.M. Segura Cabral1

1Hospital La Paz, Gastroenterology, Madrid, Spain

Background: Anti-TNF therapies are effective inducing and maintaining remission in IBD. Acute infusion reactions to infliximab are a safety concern with a reported rate of 10–20%. The aim of this report is to review infusional reactions in an IBD Unit.

Methods: All infliximab infusion received in our IBD Day Care Centre since its opening in March 2007 were recorded. Infusions were given over a 2 hours period. Blood pressure and heart rate were measured before and after treatment. Patients were monitored for one hour before discharged. Presence of any symptom during or after the infusions was recorded. A specific protocol for management of reactions was followed.

Results: 129 patients received 1524 Infliximab infusions (mean 11.85 per patient; sd 8.9) from March 2007 to October 2011.

60 patients (46.5%) were male and 69 (53.5%) female. The indication was Crohn's disease in 99 patients (76.7%) and ulcerative colitis in 30 (23.3%). Mean age at start of the therapy was 39.05 years (range15–77).

Immunosuppressive therapies (azathioprine 6‑MP or methotrexate) were used in 77.5% of the patients.

Premedication with hydrocortisone and dexclorfeniramine was used, at least once, in 46 patients.

A total of 25 patients were affected by 39 infusion reactions; this represents 19.4% of patients and 2.6% of all infusions. Reactions were mild in 30 cases (76.9%), moderate in 8 (20.5%) and severe in one (2.5%) due to significant dyspnea. None of the patients required hospitalization.

No significant differences were observed between patients with or without reactions in gender, indication or use of immunosupressors.

Hypotension defined as decrease from basal ≥ 20 mmHg was the most frequent sign, appearing in 17 (68%) of the patients with reactions and 25 (64.1%) of the reactions. Of these 1 required infusion of saline and the other 24 were asymptomatic and resolved spontaneously.

Pruritus and cutaneous rash occurred in 10 infusions (25.6% reactions) affecting 7 patients (28%), dyspnea in 2 (8% patients 5.1% reactions). Facial oedema occurred in 2 infusions (5.1% reactions).

All of these symptoms resolved after slowing or stopping the infusion and the administration of hydrocortisone, dexclorfeniramine or paracetamol following protocol. In 8 patients infliximab treatment was suspended due to the reactions occurred (6.2%).

Conclusions: Infliximab infusion is well tolerated, acute reaction appears in 2.6% of infusions, most are mild and asymptomatic, and lead to the discontinuation of the treatment in only 6.2% of patients treated.