Open-label infliximab therapy in Crohn's disease: a long-term multicenter study of efficacy, safety and predictors of response.
BACKGROUND
Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response.


METHODS
Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14 wks.


RESULTS
169 patients included (48%males, mean age 39 +/- 12 yrs). 64% of them had perianal disease. 82% were under immunosuppressants. 1,355 infliximab infusions administered (mean 8, range 1-30). 90% response rate and 48% remission rate were obtained with induction therapy. 73% followed maintenance treatment, and 78% of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41 wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10% of the patients, 1.2% of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26% of the patients, and were cause of treatment withdrawal in 7 patients.


CONCLUSIONS
Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.
González-Lama
Yago
Y
La Princesa University Hospital (Universidad Autónoma) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd II).
López-San Román
Antonio
A
Marín-Jiménez
Ignacio
I
Casis
Begoña
B
Vera
Isabel
I
Bermejo
Fernando
F
Pérez-Calle
José Lázaro
JL
Taxonera
Carlos
C
Martínez-Silva
Francisca
F
Menchén
Luis
L
Martínez-Montiel
Pilar
P
Calvo
Marta
M
Carneros
José Antonio
JA
López
Pilar
P
Mendoza
Juan Luis
JL
Milicua
José María
JM
Huerta
Alaín
A
Sánchez
Fernando
F
Abreu
Luis
L
López-Palacios
Natalia
N
Maté
José
J
Gisbert
Javier P
JP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab