Table 11.
GRADE Evidence Profile comparing continuing vs. stopping 5-aminosalicylates in biologic- and/or immunomodulator-treated patients with moderate to severe ulcerative colitis who have failed 5-aminosalicylates.
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CONTINUING 5-AMINOSALICYLATE COMPARED TO STOPPING 5-AMINOSALICYLATE in biologic- and/or immunomodulator-treated patients with MODERATE TO SEVERE ULCERATIVE COLITIS who have FAILED 5-ASA | ||||||
|---|---|---|---|---|---|---|
| Outcomes | Study event rates (95% CI) | Relative effect (95% CI) | Absolute effect* | No of participants (studies) | Quality of the evidence (GRADE) | |
| Induction of clinical remission (CRITICAL) | 68/273 (24.9%) | 234/1035 (22.6%) | RR 0.94 (0.74 to 1.18) | 15 fewer per 1,000 (from 65 fewer to 45 more) | 1308 (5 RCTs) | ⨁⨁◯◯1,2 LOW |
| Maintenance of clinical remission (CRITICAL) | 97/203 (47.8%) | 308/721 (42.7%) | RR 0.92 (0.78 to 1.09) | 38 fewer per 1,000 (from 105 fewer to 43 more) | 924 (4 RCTs) | ⨁⨁◯◯1,2 LOW |
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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 indirectness (not trials of continuing vs. stopping 5-ASA, but rather concomitant 5-ASA vs. no concomitant 5-ASA at trial entry)
2
Rated down for serious imprecision with wide CIs