Short-term effectiveness of golimumab for ulcerative colitis: Observational multicenter study
Por:
Bosca-Watts MM, Cortes X, Iborra M, Huguet JM, Sempere L, Garcia G, Gil R, Garcia M, Munoz M, Almela P, Maroto N and Paredes JM
Publicada:
21 dic 2016
Resumen:
AIM
To evaluate the real-world effectiveness of golimumab in ulcerative
colitis (UC) and to identify predictors of response.
METHODS
We conducted an observational, prospective and multi-center study in UC
patients treated with golimumab, from September 2014 to September 2015.
Clinical activity was assessed at wk 0 and 14 with the physician' s
global clinical assessment (PGA) and the partial Mayo score.
Colonoscopies and blood tests were performed, following daily-practice
clinical criteria, and the results were recorded in an SPSS database.
RESULTS
Thirty-three consecutive patients with moderately to severely active UC
were included. Among them, 54.5% were female and 42 years was the
average age. Thirty percent had left-sided UC (E2) and 70% had extensive
UC (E3). All patients had an endoscopic Mayo score of 2 or 3 at
baseline. Twenty-seven point three percent were anti-tumor necrosis
factor (TNF) treatment naive, whereas 72.7% had previously received
infliximab and/or adalimumab. Sixty-nine point seven percent showed
clinical response and were steroid-free at wk 14 (a decrease from
baseline in the partial Mayo score of at least 3 points). Based on PGA,
the clinical remission and clinical response rates were 24% and 55%
respectively. Withdrawal of corticosteroids was observed in 70.8% of
steroid-dependent patients at the end of the study. Three out of 10
clinical non-responders needed a colectomy. Mean fecal calprotectin
value at baseline was 300 mu g/g, and 170.5 mu g/g at wk 14. Being
anti-TNF treatment naive was a protection factor, which was related to
better chances of reaching clinical remission. Twenty-seven point three
percent of the patients required treatment intensification at 14 wk of
followup. Only three adverse effects (AEs) were observed during the
study; all were mild and golimumab was not interrupted.
CONCLUSION
This real-life practice study endorses golimumab's promising results,
demonstrating its short-term effectiveness and confirming it as a safe
drug during the induction phase.
Filiaciones:
Bosca-Watts MM:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
Iborra M:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
Huguet JM:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
Sempere L:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
Maroto N:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
:
Marta Maia Bosca-Watts, Inflammatory Bowel Disease Unit, Digestive Disease Department, University of Valencia, University Clinic Hospital of Valencia, 46010 Valencia, Spain
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