Six year adalimumab efficacy in steroid-dependent Crohn's disease patients: A prospective single-center real life
Ambrogio Orlando1, Sara Renna1, Filippo Mocciaro2
1DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
Insights
Long-term adalimumab maintenance therapy demonstrated sustained clinical remission in 41% of patients with steroid-dependent Crohn's disease over six years. This real-world study confirms its safety and efficacy for managing this chronic condition.
Area of Science:
- Gastroenterology
- Immunology
- Clinical Medicine
Background:
- Adalimumab is an established treatment for Crohn's disease.
- Previous data showed 64.5% remission in 110 steroid-dependent patients at study end.
- This study extends follow-up for responders.
Purpose of the Study:
- To assess the long-term efficacy and safety of adalimumab maintenance therapy.
- Evaluate outcomes after 6 years in patients who initially responded to adalimumab.
- Analyze clinical remission and safety in a real-world setting.
Main Methods:
- Prospective extension study of 90/110 patients from a previous cohort.
- Assessed clinical remission and safety over a 6-year maintenance period.
- Collected endoscopy data for patients in remission.
Main Results:
- After approximately 6 years, 41% (37/90) of patients maintained clinical remission.
- 52% (47/90) discontinued adalimumab due to clinical failure, and 7% (6/90) due to adverse events.
- Among those continuing adalimumab in remission, 45% showed endoscopic improvement.
Conclusions:
- Adalimumab provides long-term effective and safe maintenance treatment for steroid-dependent Crohn's disease.
- Real-world data supports adalimumab's role in sustained remission.
- The study highlights the importance of long-term monitoring for treatment outcomes.
Background:
Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission.
Aims:
To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment.
Methods:
The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab.
Results:
Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16±10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome.
Conclusions:
This "real life" prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.
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