Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study

Suzuki, Yasuo; Hagiwara, Takeshi; Kobayashi, Mariko; Morita, Kazuo; Shimamoto, T; Hibi, Toshifumi

doi:10.5217/ir.2020.00013

Cited by 24 publications

(32 citation statements)

References 36 publications

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“…9 Previous studies have shown that anti-TNF agents, including infliximab and adalimumab, led to the relief of gastrointestinal symptoms and ulcers in gastrointestinal tract in patients with Behcet's disease. [15][16][17][27][28][29][30][31][32][33][34][35][36] However, these studies were single-arm cohort studies. No randomized clinical trials have been conducted in this field.…”

Section: Discussionmentioning

confidence: 99%

“…Gastrointestinal involvement was considered more dangerous to patients with Behcet's disease, as the prognosis was usually worse 9 . Previous studies have shown that anti‐TNF agents, including infliximab and adalimumab, led to the relief of gastrointestinal symptoms and ulcers in gastrointestinal tract in patients with Behcet's disease 15–17,27–36 . However, these studies were single‐arm cohort studies.…”

Section: Discussionmentioning

confidence: 99%

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The efficacy and safety of anti‐tumor necrosis factor agents in the treatment of intestinal Behcet's disease, a systematic review and meta‐analysis

Zhang

Liu

et al. 2022

J of Gastro and Hepatol

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Background and Aim: Behcet's disease is a systemic vasculitis that can involve gastrointestinal tract. This is a systematic review and meta-analysis evaluating the efficacy and safety of anti-tumor necrosis factor (TNF) agents in treating patients with intestinal Behcet's disease. Methods: We conducted searches on PubMed, Embase, and Cochrane. Data from eligible studies were used to calculate the pooled estimate of proportions of clinical remission, mucosal healing at Months 3, 6, 12, and 24 as well as the pooled incidence of adverse drug reactions. And subgroup analysis based on the specific type of anti-TNF agents was performed. Results: Of the 828 studies initially identified, 13 were included finally, all of which were single-arm cohort studies. The pooled proportions of clinical remission at Months 3, 6, 12, and 24 were 0.61 (95%CI 0.48-0.78), 0.51 (95%CI 0.40-0.66), 0.57 (95%CI 0.48-0.67), and 0.38 (95%CI 0.16-0.88), respectively. The pooled proportions of mucosal healing at Months 3, 6, 12, and 24 were 0.66 (95%CI 0.50-0.86), 0.82 (95%CI 0.48-0.98), 0.65 (95%CI 0.51-0.81), and 0.69 (95%CI 0.39-1.00), respectively. The pooled estimate of proportion of overall adverse drug reactions for infliximab was 0.22 (95%CI 0.07-0.69). Conclusions: Anti-TNF agents, including infliximab and adalimumab, were an efficient therapy for intestinal Behcet's disease. The safety of anti-TNF agents used in the treatment of intestinal Behcet's disease was acceptable.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The efficacy and safety of anti‐tumor necrosis factor agents in the treatment of intestinal Behcet's disease, a systematic review and meta‐analysis

Zhang

Liu

et al. 2022

J of Gastro and Hepatol

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“…One patient who was treated for pre-existing chronic myelomonocytic leukemia experienced relapse thereof during the follow-up period. 24 Meanwhile, the safety of anti-TNF-α therapy in ulcerative colitis has been evaluated in 2088 patients, and a frequency of serious side effects of 16.9% was reported. 38 Despite a lower frequency of SAEs was indicated in our study, further research is needed to explore the feasibility of anti-TNF-α agents for treatment of intestinal BD.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Anti-Tumor Necrosis Factor-Alpha Agents for Patients with Intestinal Behcet’s Disease: A Systematic Review and Meta-Analysis

Zhang

Dong

et al. 2022

Yonsei Med J

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Purpose Intestinal Behcet’s disease (BD) is a systemic autoimmune disease for which treatment options are limited. As a prospective therapeutic strategy for intestinal BD, anti-tumor necrosis factor-alpha (anti-TNF-α) agents have received increasing attention. In this study, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of anti-TNF-α agents for patients with intestinal BD. Materials and Methods We searched PubMed, Embase, and Cochrane Library databases up to July 1, 2021 and articles that met the eligibility criteria were further assessed. Pooled rates were synthesized by a randomized effects model using Stata software. Results Eleven clinical trials covering 671 patients with intestinal BD were included. According to compositive data, the pooled rate for remission was 39% [95% confidence interval (CI) 26–52] in patients receiving anti-TNF-α agents. Intestinal symptoms were cured in 70% (95% CI 53–84) of the patients, and the rate for endoscopic healing was 65% (95% CI 52–78). Corticosteroid discontinuation was achieved in 43% (95% CI 28–58) of the patients, and the dose reduction of corticosteroid was 20.43 mg (95% CI 13.4–27.46). There were 239 adverse events and 80 serious adverse events during follow-up. Conclusion Our study indicated that anti-TNF-α agents may serve as an effective treatment with acceptable safety for patients with intestinal BD. However, more robust evidence from randomized controlled trials is urgently needed to assess the long-term efficacy and safety of anti-TNF-α agents for those patients.

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“…15 A prospective observational study of 462 Japanese patients with intestinal Behçet's disease treated with adalimumab reported the long-term efficacy and safety of adalimumab. 16 In Japan, anti-TNF-α antibodies available for treating intestinal Behçet's disease include infliximab and adalimumab. Administration of adalimumab at 80 mg every 2 weeks is not approved for patients with intestinal Behçet's disease who insufficiently respond to treatment, unlike in the case of patients with Crohn's disease.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Anti-Tumor Necrosis Factor-α Therapy Against Intestinal Behçet’s Disease Complicated by Recurrent Enterocutaneous Fistulae

Kashima¹,

Matsumoto²,

Kojima³

et al. 2022

BTT

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A 55-year-old man presented with recurrent ulcers and an enterocutaneous fistula at the anastomotic site after surgery for an ileovesical fistula and was diagnosed with intestinal Behçet's disease after undergoing surgery for enterocutaneous fistulae twice. The patient was transferred to our hospital because of recurrent enterocutaneous fistulae. He had a history of recurrent oral aphthous ulcers, folliculitis, and epididymitis and met the diagnostic/classification criteria for incomplete Behçet's disease and thus was diagnosed as having intestinal Behçet's disease. Remission induction therapy with steroids was administered for an ileal ulcer and an enterocutaneous fistula, and adalimumab was initiated for maintenance therapy. The fistula was closed, and the clinical course was favorable. Two months after initiating adalimumab, a subcutaneous abscess was detected at the site of the enterocutaneous fistula scar, and relapse of intestinal Behçet's disease was suspected. Steroids were re-administered for remission induction, followed by maintenance therapy, for which adalimumab was switched to infliximab. No relapse was detected after steroid withdrawal. No therapeutic strategies have been established for intestinal Behçet's disease. Moreover, there have been very few reports on therapeutic strategies and postoperative maintenance therapy for enterocutaneous fistulae. We thus consider this case valuable.

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Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study

Cited by 24 publications

References 36 publications

The efficacy and safety of anti‐tumor necrosis factor agents in the treatment of intestinal Behcet's disease, a systematic review and meta‐analysis

The efficacy and safety of anti‐tumor necrosis factor agents in the treatment of intestinal Behcet's disease, a systematic review and meta‐analysis

Efficacy and Safety of Anti-Tumor Necrosis Factor-Alpha Agents for Patients with Intestinal Behcet’s Disease: A Systematic Review and Meta-Analysis

Efficacy of Anti-Tumor Necrosis Factor-α Therapy Against Intestinal Behçet’s Disease Complicated by Recurrent Enterocutaneous Fistulae

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