Inflamm Bowel Dis. 2018 Jun 15. doi: 10.1093/ibd/izy219. [Epub ahead of print]
P.Bossuyt, F.Baert, F.D'Heygere, A.Nakad, C.Reenaers, F.Fontaine, D.Franchimont, O.Dewit, P.Van Hootegem, S.VandenBranden, G.Lambrecht, M.Ferrante; Belgian IBD Research and Development Group
abstract
Golimumab (GOL) is registered for moderate to severely active ulcerative colitis (UC). Data on the use of GOL in daily clinical practice are limited. Currently, it is unclear which factors are predictive of a favorable outcome. The goals of this study were to evaluate the mid-term outcome of GOL (week 26) in patients with moderate to severe UC and to determine predictors of favorable outcome.
Patients included in the SMART study (NCT02155335) were evaluated for their mid-term outcome. Demographic data, disease characteristics, and medical history were recorded retrospectively. Data on disease activity based on total Mayo score, previous and concomitant medication, GOL dosing, mucosal healing (Mayo 0 or 1), adverse events (colectomy, hospitalization), and biomarkers (C-reactive protein, fecal calprotectin, hemoglobin, and albumin) were collected at baseline and weeks 2, 6, 14, 26, and 52. GOL was dosed at 200 and 100 mg at weeks 0 and 2, respectively, and 50 mg (<80 kg body weight) or 100 mg (≥80 kg body weight) every 4 weeks thereafter. The primary end point was steroid-free GOL continuation at week 26.
From the 91 evaluable patients (42% female; median age, 42 years; median disease duration, 5 years), 4% were active smokers, 25% had extensive colitis, and 38% had an endoscopic Mayo score of 3 at baseline. The median (interquartile range [IQR]) baseline Mayo score was 9 (8–10). Although 75% of patients had previously failed immunomodulators (IMMs), the majority (87%) were anti–tumor necrosis factor (TNF) naïve. GOL was started in combination with IMM in 40% and steroids in 64%. The median (IQR) duration of GOL therapy during follow-up was 35.7 (11.4–105.7) weeks. Twenty-six weeks after GOL induction, 37 patients (41%) were steroid-free and still on GOL, of whom 8 (21.6%) required GOL dose optimization. Short-term mucosal healing (STMH) at week 14 was evaluated in 60% of the patients. Considering the whole cohort, only 40% achieved STMH. No predictors could be retained of short-term treatment outcome. In multivariate analysis, STMH was predictive of steroid-free GOL continuation at week 26 (odds ratio [OR], 5.56; 95% confidence interval [CI], 1.90–16.29; P = 0.002) and week 52 (OR, 9.38; 95% CI, 2.68–32.84; P < 0.001). In patients continuing GOL after week 14, STMH was predictive of intervention-free survival (OR, 2.05; 95% CI, 1.09–3.86; P = 0.026) and discontinuation-free survival (OR, 3.47; 95% CI, 1.58–7.58; P = 0.002). During follow-up, 78% needed an intervention, 68% discontinued GOL, and 3 patients needed a colectomy.
Real-life data confirm the moderate effectiveness of GOL on the mid-term in active UC, but therapeutic interventions are frequently needed. Short-term mucosal healing predicts a favorable outcome.
Legend: Coordinating PI Participants
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BE-SMART | CEDAR-UC | Combined therapy of biologicals and new oral drugs. | DETECT | DNA banking | GENGISCAN | HELP-AID | I-CARE | Immunization | LOVE | PACIFIC | Pediatric | SPARE | |
Karen Van Hoeve | |||||||||||||
- - | x | x | x | x | |||||||||
Leila Amininejad | x | x | x | ||||||||||
Saskia Appelmans | |||||||||||||
Thomas Billiet | |||||||||||||
Patrick Bontems | |||||||||||||
Isabelle Bueres | |||||||||||||
Katrien Bulté | |||||||||||||
Guillaume Burnet | |||||||||||||
Peter Burvenich | |||||||||||||
Julie Busschaert | |||||||||||||
Philippe Caenepeel | |||||||||||||
Olivier Cajot | |||||||||||||
Christophe Claessens | x | ||||||||||||
Jean-Charles Coche | |||||||||||||
Jean-Louis Coenegrachts | |||||||||||||
Arnaud Colard | x | ||||||||||||
Filip Couturier | |||||||||||||
Lara Crapé | |||||||||||||
Anneline Cremer | |||||||||||||
Anneline Cremer | x | x | |||||||||||
Cléo Croonen | |||||||||||||
Francois D'Heygere | x | ||||||||||||
Steven De Coninck | |||||||||||||
Elisabeth De Greef | x | ||||||||||||
Marc De Maeyer | |||||||||||||
Marc De Reuck | |||||||||||||
Elodie De Ruyck | |||||||||||||
Nicolas de Suray | |||||||||||||
Martine De Vos | x | x | x | x | |||||||||
Benedicte De Vroey | |||||||||||||
Astrid De Zutter | |||||||||||||
Stefan Delen | |||||||||||||
Marie-Armelle Denis | |||||||||||||
Pieter Dewint | x | x | |||||||||||
Olivier Dewit | x | x | x | ||||||||||
Sophie Dewit | x | x | |||||||||||
Joris Dutre | |||||||||||||
Anke Engelen | |||||||||||||
Marc Etienne | |||||||||||||
Marc Ferrante | x | x | x | x | x | ||||||||
René Fiasse | |||||||||||||
Fernand Fontaine | x | x | |||||||||||
Denis Franchimont | x | x | x | x | x | x | |||||||
Silke François | |||||||||||||
Jeroen Geldof | |||||||||||||
Bruno Hauser | |||||||||||||
Pieter Hindryckx | x | ||||||||||||
Ilse Hoffman | |||||||||||||
Tom Holvoet | |||||||||||||
Alice Hoyois | |||||||||||||
Evelien Humblet | x | ||||||||||||
Saskia Ilegems | |||||||||||||
Aranzazu Jauregui Amezaga | |||||||||||||
Guy Lambrecht | x | x | x | ||||||||||
Pierre Lammens | |||||||||||||
Katrien Lecluyse | |||||||||||||
Claire Liefferinckx | x | ||||||||||||
Triana Lobaton | |||||||||||||
Edouard Louis | x | x | x | x | x | ||||||||
Elisabeth Macken | x | ||||||||||||
Marie-Christine Mairlot | |||||||||||||
Jean-Marc Maisin | |||||||||||||
Fazia Mana | x | ||||||||||||
Ludwig Marchal | |||||||||||||
Walter Margos | |||||||||||||
Fady Mokaddem | |||||||||||||
Kim Moubax | |||||||||||||
Vinciane Muls | |||||||||||||
Carmen Musala | |||||||||||||
Michele Ngassa | |||||||||||||
Maja Noman | |||||||||||||
Hanne Ooms | |||||||||||||
An Outtier | |||||||||||||
Romy Ouziel | |||||||||||||
Harald Peeters | |||||||||||||
Annelies Posen | |||||||||||||
Philippe Potvin | |||||||||||||
Lieven Pouillon | |||||||||||||
Jean-Francois Rahier | x | x | x | x | x | x | |||||||
Catherine Reenaers | x | x | x | ||||||||||
João Sabino | |||||||||||||
João Sabino | |||||||||||||
Michael Schapira | |||||||||||||
Nathalie Schoofs | |||||||||||||
Nele Schoofs | |||||||||||||
Alexandra Sermeus | |||||||||||||
Francoise Smets | |||||||||||||
Michaël Somers | |||||||||||||
Dirk Staessen | |||||||||||||
Marjan Steppe | |||||||||||||
Beatrijs Strubbe | x | ||||||||||||
Jo Swinnen | |||||||||||||
Clara Thienpont | |||||||||||||
Marie Truyens | |||||||||||||
Haydeh Vafa | |||||||||||||
Stephanie Van Biervliet | |||||||||||||
Frank Van De Mierop | |||||||||||||
Gaëtan Van Den Steen | |||||||||||||
Jurgen Van Dongen | |||||||||||||
Evi Van Dyck | |||||||||||||
Andre Van Gossum | |||||||||||||
Karen Van Hoeve | |||||||||||||
Philippe Van Hootegem | x | x | |||||||||||
Catherine Van Kemseke | |||||||||||||
Wouter Van Moerkercke | x | x | x | ||||||||||
Steven Van Outryve | |||||||||||||
Stijn Vanden Branden | x | x | x | x | |||||||||
Sofie Vanderhasselt | |||||||||||||
Liv Vandermeulen | |||||||||||||
Jo Vandervoort | |||||||||||||
Laura Vansteenkiste | |||||||||||||
Gigi Veereman | x | ||||||||||||
Severine Vermeire | x | x | x | ||||||||||
Annelies Verreth | |||||||||||||
Bram Verstockt | |||||||||||||
Sophie Vieujean | |||||||||||||
Francis Weyn | |||||||||||||
Barbara Willandt |