Abstract
Background
Adalimumab is the second tumour necrosis factor antagonist (anti-TNF) adopted for
the treatment of ulcerative colitis. Clinical data from naïve patients are scarce.
Aim
Examine the response to adalimumab in TNF-antagonist-naïve patients.
Methods
This multicentre, observational, prospective study was conducted using a cohort of
consecutive patients with ulcerative colitis. Clinical remission, mucosal healing
and deep remission were examined employing the Mayo Score and Mayo Endoscopic Score.
Clinical response was assessed using the Partial Mayo Score.
Results
Of 53 individuals included in this study, 49.1% of patients were in clinical remission
at week 8 and 60.3%, at week 52. Clinical response was observed in 84.9% and 69.8%,
respectively. Mucosal healing was found in 62.3% and 67.9% of the patients, and 43.4%
and 58.4% showed deep remission at week 8 and 52, respectively. After a year, 71.7%
of the patients continued the adalimumab treatment. Adverse effects were observed
in 28.3% of patients. Multivariate analysis showed that the long-term factor predictive
of response at week 52 was the response in week 8 (expressed as Mayo Score; OR 0.66;
95% IC 0.1–0.67, p < 0.006).
Conclusions
Adalimumab treatment of ulcerative colitis is effective; the results are better in
clinical practice and in patients naïve to anti-TNF.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Digestive and Liver DiseaseAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Infliximab for induction and maintenance therapy for ulcerative colitis.N Eng J Med. 2005; 353: 2462-2476
- Long-term outcome after infliximab for refractory ulcerative colitis.J Crohns Colitis. 2008; 2: 219-225
- Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial.Gut. 2011; 60: 780-787
- Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis.Gastroenterology. 2012; 142: 257-265
- Early mucosal healing with infliximab is associated with improved long-term clinical outcomes in ulcerative colitis.Gastroenterology. 2011; 141: 1194-1201
- Mucosal healing predicts late outcomes after the first course of corticosteroids for newly diagnosed ulcerative colitis.Clin Gastroenterol Hepatol. 2011; 9: 483-489
- Achievement of deep remission during scheduled maintenance therapy with TNF alpha-blocking agents in IBD.J Crohns Colitis. 2013; 7: 730-735
- Adalimumab induces deep remission in patients with Crohn’s disease.Clin Gastroenterol Hepatol. 2014; 12: 414-422
- Observational study on the efficacy of adalimumab for the treatment of ulcerative colitis and predictors of outcome.J Crohns Colitis. 2013; 7: 717-722
- Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease.Inflamm Bowel Dis. 2012; 18: 2218-2224
- Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: diagnostic meta-analysis.BMJ. 2010; 341c3369
- Fecal calprotectin concentration predicts outcome in inflammatory bowel disease after induction therapy with TNFα blocking agents.Inflamm Bowel Dis. 2012; 18: 2011-2017
- Second European evidence-based consensus on the diagnosis and management of ulcerative colitis: definitions and diagnosis.J Crohns Colitis. 2013; 7: 1-33
- Classification of inflammatory bowel disease.Scand J Gastroenterol. 1989; 170: 2-6
- Toward an integrated clinical, molecular and serological classification of inflammatory bowel disease: report of a Working Party of the 2005 Montreal World Congress of Gastroenterology. Ulcerative colitis clinical classification.Can J Gastroenterol. 2005; 19: 9A-13A
- Coated oral 5-aminosalícylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study.N Eng J Med. 1987; 317: 1625-1629
- Treatment of ulcerative colitis with adalimumab or infliximab: long-term follow-up of a single-centre cohort.Aliment Pharmacol Ther. 2010; 32: 522-528
- Adalimumab in active ulcerative colitis: a “real-life” observational study.Dig Liver Dis. 2013; 45: 738-743
- Long-term assessment of clinical response to adalimumab therapy in refractory ulcerative colitis.Eur J Gastroenterol Hepatol. 2016; 28: 217-221
- Effectiveness of adalimumab for ambulatory ulcerative colitis patients after failure of infliximab treatment: a first “real-life” experience in primary gastroenterology centers in Italy.Ann Gastroenterol. 2014; 27: 369-373
- Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis.J Gastroenterol. 2014; 49: 283-294
- Evaluation of the risk of relapse in ulcerative colitis according to the degree of mucosal healing (Mayo 0 vs 1): a longitudinal cohort study.J Crohns Colitis. 2016; : 13-19
- Efficacy and safety of dalimumab in ulcerative colitis refractory to conventional therapy in routine clinical practice.J Crohns Colitis. 2016; 10: 26-30
- Adalimumab induces deep remission in patients with Crohn’s disease.Clin Gastroenterol Hepatol. 2014; 12 (414–422.e5)
- Dose escalation and healthcare resource use among ulcerative colitis patients treated with adalimumab in English hospitals: an analysis of real-world data.PLoS One. 2016; 26: 1-9
- Effectiveness of adalimumab for the treatment of ulcerative colitis in clinical practice: comparison between anti-tumour necrosis factor-naïve and non-naïve patients.J Gastroenterol. 2017; 52: 788-799
- Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ULTRA 1, 2, and 3.Am J Gastroenterol. 2014; 109: 1771-1780
- Adalimumab maintenance treatment in ulcerative colitis: outcomes by prior anti-TNF use and efficacy of dose escalation.Dig Dis Sci. 2017; 62: 481-490
- Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis.Aliment Pharmacol Ther. 2014; 40: 486-497
- 52-week clinical efficacy with adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunossupresants.Gut. 2011; 60: A139
- Clinical experience with adalimumab in anti-TNF-naïve patients with ulcerative colitis.J Crohns Colitis. 2013; 7e195
- Combination therapy with infliximab and azathioprine is superior to monotherapy with either agent in ulcerative colitis.Gastroenterology. 2014; 146: 392-400
- Durable clinical remission and response in adalimumab treatment patients with ulcerative colitis.10th. Congress of ECCO, Barcelona. 2015; (P356)
Travis S, Feagan BG, Peyrin-Biroulet L, Panaccione R, Danese S, Lazar A, et al. Mo1096 Effect of Adalimumab on Clinical Outcomes and Health-Related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From INSPIRADA. April 2016, Vol. 150, Issue 4, Supplement 1, p. S633.
- Adalimumab induction and maintenance therapy for patients with ulcerative colitis previously treated with infliximab.Aliment Pharmacol Ther. 2011; 33: 340-348
- The effect of adalimumab therapy on the risk of hospitalization in patients with ulcerative colitis.Gastroenterology. 2014; 146: 110-118
Article info
Publication history
Published online: March 14, 2018
Accepted:
March 6,
2018
Received in revised form:
February 27,
2018
Received:
November 16,
2017
Identification
Copyright
© 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
