Open-label infliximab therapy in ulcerative colitis: a multicenter survey of results and predictors of response.
OBJECTIVE
Results of randomized controlled trials showing efficacy of infliximab in ulcerative colitis (UC) should be confirmed in clinical practice. We aimed to evaluate the efficacy and safety of infliximab in UC patients of the Madrid area, looking for clinical predictors of response.


METHODS
Multicenter retrospective survey of all UC patients treated with infliximab in the region of Madrid (Spain).


RESULTS
47 UC patients were included (45% males, mean age 44 +/- 15 yrs), mean follow up of 4.7 months (range 0.5-21), and a total number of 211 infliximab infusions. Clinical response and steroid-free remission rates were, respectively, 97/42% in the 2nd week, 93/69% in the 6th week, and 80/65% at the long-term follow up (mean 8.2 months, range 3.5-21). Colectomy rate was 10.6% (five patients). Age, gender, disease duration, indication (steroid-resistance/dependence), disease severity, C-reactive protein, concomitant thiopurinic therapy or smoking habit did not influence on efficacy. Extent of the disease was the only predictive factor (p=0.02). Only 4 cases of mild adverse events were reported.


CONCLUSIONS
Infliximab is effective and safe for UC. Real life clinical practice may have better outcome than showed in randomized controlled trials. Extent of the disease was the only predictive factor for clinical response in our experience.
Gonzalez-Lama
Yago
Y
Digestive Department of La Princesa Universitary Hospital, Madrid, Spain.
Fernandez-Blanco
Ignacio
I
Lopez-SanRoman
Antonio
A
Taxonera
Carlos
C
Casis
Begoña
B
Tabernero
Susana
S
Bermejo
Fernando
F
Martinez-Silva
Francisca
F
Mendoza
Juan Luis
JL
Martinez-Montiel
Pilar
P
Carneros
Jose Antonio
JA
Sanchez
Fernando
F
Maté
Jose
J
Gisbert
Javier P
JP
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000069285:Infliximab; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab