Adalimumab for induction of histological remission in moderately to severely active ulcerative colitis
Digestive Diseases and Sciences Jan 29, 2018
Fernandez-Blanco JI, et al. - Here, researchers evaluated the ability of adalimumab to achieve histological remission in ulcerative colitis (UC) patients. In anti-TNF naïve patients with moderately to severely active UC, adalimumab was able to achieve histological remission.
Methods
- Single-center, retrospective, open-label study of patients treated with adalimumab was performed.
- For this study, eligible patients were anti-TNF naïve adults with moderately to severely active UC.
- They performed the Mayo score including endoscopy at baseline and weeks 8 and 52.
- Using the Geboes Index, histological activity was scored.
- Histological remission was the primary endpoint, which was defined as a Geboes grade ≤ 3.0, at week 52.
Results
- A total of 34 patients were included.
- Six of 34 patients (17.6%) achieved histological remission at week 8.
- Nine patients (26.5%, intention to treat; 31%, per protocol) had histological remission at week 52.
- In the most severe subgrades of Geboes Index, patients had a significant and progressive reduction from baseline at weeks 8 and 52.
- Fifty percent and 61.8% of patients achieved mucosal healing (Mayo endoscopic subscore 0-1) at weeks 8 and 52.
- Furthermore, all patients who achieved histological remission had mucosal healing.
- In this study, 85.3 and 20.6% of patients achieved clinical response (decrease in Mayo score ≤ 3 points) or remission (Mayo score ≤ 2), respectively, at week 8.
- The corresponding values were 67.6 and 52.9%, respectively, at week 52.
- Agreement between histological remission and mucosal healing was fair (kappa 0.293) at week 52.
- Findings revealed that agreement between histological remission and Mayo endoscopic subscore 0 was good (kappa 0.71).
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