Observational Study
Copyright ©The Author(s) 2016.
World J Gastroenterol. Dec 21, 2016; 22(47): 10432-10439
Published online Dec 21, 2016. doi: 10.3748/wjg.v22.i47.10432
Table 1 Baseline characteristics of the patients n (%)
Variables
Female18 (54.4)
Mean age13
Extent of disease
Proctitis0
Left-side colitis12 (30)
Extensive colitis21 (70)
Current smokers2 (11.1)
Endoscopic Mayo score 2-330 (100)
No previous endoscopy3
Clinical situation before golimumab
Mild-remission5 (15.2)
Moderate-severe28 (84.8)
Golimumab indication
Induction of remission28 (84.8)
Maintenance of remission3 (9.1)
Extra-intestinal manifestations2 (11.1)
Previous anti-TNF use24 (72.7)
Use of > 1 anti-TNF16 (48.5)
Previous anti-TNF failure
Primary non-responders6 (25)
Loss of response14 (58.3)
Infusion reaction4 (16.6)
Previous steroid consumption (31 patients had previous steroid consumption)
Steroid-refractory7 (27.3)
Steroid-dependent24 (72.7)
Use of steroids at induction25 (75.7)
Associated immunosuppressors12 (36.6)
Azathioprine11 (33.3)
Tacrolimus1 (3)
Table 2 Bivariant analysis with steroid-free remission according to Mayo score at week 14 of golimumab treatment n (%)
VariableNO SFR: n = 16 (48.5)SFR: n = 17 (51.5)P value
Age (yr)38.36 ± 13.646.35 ± 13.7NS
Mo since diagnosis72.20 ± 96.1174.65 ± 67.65NS
Female sex10 (62.5)8 (47.1)NS
Diagnosis < 2 yr7 (46.7)14 (82.4)0.03
Anti-TNF naïve3 (18.8)6 (35.3)NS
> 1 previous anti-TNF9 (56.3)7 (41.2)NS
Steroid-dependent15 (93.8)9 (52.9)0.01
Steroid-refractory4 (25.0)3 (17.6)NS
mean ± SD
Table 3 Bivariant analysis with steroid-free clinical response according to Mayo score at week 14 of golimumab treatment, n (%)
VariableNo clinical response n = 8 (24.2)Clinical response n = 25 (75.8)P value
Age (yr)42.71 ± 8.643.78 ± 14.9NS
Mo since diagnosis56.14 ± 6877.35 ± 87.9NS
Female sex7 (87.5)11 (44)0.04
Diagnosis < 2 yr4 (50)17 (70.8)NS
Anti-TNF naïve3 (37.5)6 (24)NS
> 1 previous anti-TNF4 (50.0)12 (48.0)NS
Steroid-dependent8 (100)16 (64.0)0.05
Steroid-refractory2 (25.0)5 (20.0)NS
mean ± SD