Effectiveness of anti-tumour necrosis factor-α therapy in Danish patients with inflammatory bowel diseases.
BACKGROUND
The objective of this study was to evaluate the outcome of anti-tumour necrosis factor-α (anti-TNF) treatment in a large cohort of patients with inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC) in clinical practice and to establish a cohort for future studies of genetic markers associated with treatment response.


METHODS
A national, clinically based cohort of previously naïve anti-TNF treated patients from 18 medical departments was established. The patients were screened for tuberculosis prior to treatment initiation. By combining the unique personal identification number of Danish citizens (the CPR number) from blood samples with data from the National Patient Registry, patients with International Classification of Diseases, Version 10 (ICD-10) codes K50-K63 were identified. Treatment efficacy reflected the maximum response within 22 weeks.


RESULTS
Among 492 patients with CD and 267 patients with UC, 74%/13%/14% and 65%/12%/24% were responders, partial responders and non-responders to anti-TNF therapy, respectively. More patients with UC than with CD were non-responders (odds ratio (OR) = 1.96, 95% confidence interval (CI): 1.34-2.87, p = 0.001). Young age was associated with a beneficial response (p = 0.03), whereas smoking ≥ 10 cigarettes/day was associated with non-response among patients with CD (OR = 2.33, 95% CI: 1.13-4.81, p = 0.03).


CONCLUSIONS
In this clinically based cohort of Danish patients with IBD treated with anti-TNF, high response rates were found. Heavy smoking was associated with non-response, whereas young age at treatment initiation was associated with a beneficial response among patients with CD. Thus, the results obtained in this cohort recruited from clinical practice were similar to those previously obtained in clinical trials.


BACKGROUND
The work was funded by Health Research Fund of Central Denmark Region, Colitis-Crohn Foreningen and the University of Aarhus (PhD grant).


BACKGROUND
Clinicaltrials NCT02322008.
Medical Department, Viborg Regional Hospital, 8800 Viborg. stb@mb.au.dk.
Steffen
S
Bank
Paal Skytt
PS
Andersen
Johan
J
Burisch
Natalia
N
Pedersen
Stine
S
Roug
Julie
J
Galsgaard
Stine Ydegaard
SY
Turino
Jacob Broder
JB
Brodersen
Shaista
S
Rashid
Sara
S
Avlund
Thomas Bastholm
TB
Olesen
Anders
A
Green
Hans Jürgen
HJ
Hoffmann
Marianne Kragh
MK
Thomsen
Vibeke Østergaard
VØ
Thomsen
Bjørn Andersen
BA
Nexø
Ulla
U
Vogel
Vibeke
V
Andersen
D000068879:Adalimumab / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D002648:Child; D015331:Cohort Studies; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003424:Crohn Disease / Q000188:drug therapy*; D003718:Denmark; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D012042:Registries; D012189:Retrospective Studies; D012907:Smoking / Q000009:adverse effects; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*; D055815:Young Adult
D000893:Anti-Inflammatory Agents; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab