Introduction
Achieving histologic remission leads to improved outcomes for patients with ulcerative colitis (UC). However, predictors of histologic remission remain poorly defined. We aimed to identify patient and disease characteristics that predicted histologic remission in patients with UC.
Aims & Methods
The phase IV Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS) prospectively recruited UC patients in steroid-free clinical remission on vedolizumab (VED) 300mg intravenously 8-weekly and a thiopurine. All patients were in endoscopic improvement (Mayo endoscopic score 0 or 1) at baseline, with or without histologic activity. Histologic remission was defined as Nancy index=0, with central reading by a blinded gastrointestinal pathologist. Clinical variables (age, sex, disease duration, smoking status, extent of UC, concomitant medications, anti-TNF exposure) and biochemical variables (serum VED trough level, faecal calprotectin, TGN, albumin) were analysed. Odds ratios (ORs) with 95% confidence intervals (CI) were reported. Multivariate logistic regression models were performed to identify predictive factors of histologic remission at baseline. Covariates with P<0.05 were deemed statistically significant (IBM SPSS Statistics, version 30).
Results
Of 62 consecutively recruited UC patients, 54 patients had baseline histologic assessment and 76% (n=41) were in histologic remission. Baseline demographics included median age 43 years (IQR:27-60), female 44% (n=24), non-smokers 78% (n=42), ex-smokers 15% (n=8), median disease duration was 6.5 years (IQR:3-11) and 83% (n=45) were anti-TNF naïve. Current smokers (n=3) were excluded from analysis due to low numbers. Univariate predictors of histologic remission at baseline included age (OR: 0.96 [95%CI:0.93-0.99], P=0.04), non-smoking versus ex-smoking (OR: 14.93 [95%CI:2.49-90.91], P<0.001) and anti-TNF naïve (OR: 5.78 [95%CI:1.26-26.32], P=0.03). On multivariate analysis, only non-smoking versus ex-smoking predicted for histologic remission (OR: 19.65 [95%CI:1.37-281.93], P=0.03) (Table 1).
Table 1. Factors associated with histological remission at VIEWS study entry
OR, odds ratio; CI, confidence interval; UC, ulcerative colitis; TNF, tumour-necrosis factor; TGN, thioguanine; μg, microgram; mL, millilitre; g, gram.
| Variables | Univariable analysis | Multivariable analysis |
| OR (95% CI) | P-value | OR (95% CI) | P-value |
| Mean age, years | 0.96 (0.93-0.99) | 0.04 | 0.98 (0.93-1.03) | 0.49 |
Sex Female vs male | 3.50 (0.84-14.49) | 0.08 | 1.33 (0.19-9.37) | 0.77 |
Smoking Never vs. ex-smoker
| 14.93 (2.49-90.91) | <0.001 | 19.65 (1.37-281.93) | 0.03 |
Extent of UC Pancolitis vs left-sided colitis | 0.74 (0.20-2.74) | 0.65 | | |
Disease duration <5 years vs >5 years | 4.31 (0.85-21.74) | 0.06 | 8.78 (0.68-113.98) | 0.10 |
| anti-TNF naive | 5.78 (1.26-26.32) | 0.02 | 7.76 (0.99-60.71) | 0.05 |
| Vedolizumab trough concentration, μg/mL | 1.12 (0.99-1.27) | 0.07 | 1.03 (0.89-1.19) | 0.67 |
| Faecal calprotectin, μg/g | 1.00 (0.99-1.00) | 0.19 | | |
Conclusion
Non-smoking is more likely to be associated with histologic remission than ex-smoking in UC. Ex-smokers may have worse outcomes than non-smokers in UC.
Disclosure
A. Pudipeddi has received speaker fees from AbbVie, Dr Falk Pharma, Janssen, Takeda, Pfizer and Ferring, and has served on an advisory board for AbbVie. S. Paramsothy has received speaking and consulting fees from AbbVie, Janssen and Takeda. R.W. Leong advisory board membership AbbVie, Aspen, BMS, Celgene, Celltrion, Chiesi, Ferring, Glutagen, Hospira, Janssen, Lilly, MSD, Novartis, Pfizer, Prometheus Biosciences, Takeda, and research grants: Joanna Tiddy USYD, McCusker Charitable Foundation, Celltrion, Shire, Janssen, Takeda, Gastroenterological Society of Australia, NHMRC, Gutsy Group, Pfizer, Medical Research Future Fund of Australia.