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. Author manuscript; available in PMC: 2020 Apr 2.
Published in final edited form as: Gastroenterology. 2020 Jan 13;158(5):1465–1496.e17. doi: 10.1053/j.gastro.2020.01.007

Table 10.

GRADE Evidence Profile comparing biologic agents + immunomodulators vs. immunomodulator monotherapy for achieving steroid-free remission in patients with moderate to severe ulcerative colitis. Note, the trial included infliximab and azathioprine as interventions. No trial of maintenance therapy comparing biologic agents + immunomodulators vs. immunomodulator monotherapy was identified.


COMBINATION THERAPY WITH BIOLOGIC AGENTS + IMMUNOMODULATORS COMPARED TO IMMUNOMODULATOR MONOTHERAPY FOR MODERATE-SEVERE ULCERATIVE COLITIS
Outcomes Study event rates (95% CI) Relative effect (95% CI) Absolute effect* No of participants (studies) Quality of the evidence (GRADE)
Risk with Immunomodulator Risk with Combination Therapy
Achieving clinical remission (CRITICAL) 18/79 (22.8%) 31/80 (38.8%) RR 1.70 (1.04 to 2.78) 159 more per 1,000 (from 9 more to 406 more) 159 (1 RCT) ⨁⨁⨁◯1 MODERATE
GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
1

Rated down for imprecision since optimal information size not met (<200 events)