Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease

Hibi, Toshifumi; Hirohata, Shunsei; Kikuchi, Hirotoshi; Tateishi, Ukihide; Sato, Noriko; Ozaki, Kokoro; Kondo, Kazuoki; Ishigatsubo, Yoshiaki

doi:10.1097/md.0000000000003863

Cited by 80 publications

(38 citation statements)

References 31 publications

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“…The incidence of AEs under long-term adalimumab treatment in this study was similar or slightly lower than that in patients with CD who had undergone up to 4 years of treatment with adalimumab 67. According to a long-term safety analysis that included 5 indications of adalimumab, serious infections were most frequent (1.4–6.7 events/100 person-years) 4. The rate of serious infection in this study was 8.6 events/100 personyears; however, 3 events associated with appendicitis simultaneously occurred in 1 patient.…”

Section: Discussionsupporting

confidence: 57%

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

et al. 2017

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Background/AimsIntestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671).MethodsPatients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.ResultsTwenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.ConclusionsThis report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

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Section: Discussionsupporting

confidence: 57%

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

et al. 2017

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“…Methotrexate is recommended as the first line therapy for CP-P-NBD in the guidelines for management of NBD from Behcet’s Disease Research Committee, Ministry of Health, Welfare, and Labour, Japan. Favorable clinical outcomes of TNF inhibitors for both types of NBD have been accumulated including prospective study 36 .…”

Section: Discussionmentioning

confidence: 99%

Distinct clinical features between acute and chronic progressive parenchymal neuro-Behçet disease: meta-analysis

Ishido

Horita

Takeuchi

et al. 2017

Sci Rep

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Neuro-Behçet’s disease (NBD) is subcategorized into parenchymal-NBD (P-NBD) and non-parenchymal-NBD types. Recently, P-NBD has been further subdivided into acute P-NBD (A-P-NBD) and chronic progressive P-NBD (CP-P-NBD). Although an increasing number of studies have reported the various clinical features of A-P-NBD and CP-P-NBD over the last two decades, there was a considerable inconsistency. Two investigators systematically searched four electrical databases to detect studies that provided sufficient data to assess the specific characteristics of A-P-NBD and CP-P-NBD. All meta-analysis was carried out by employing the random-model generic inverse variance method. We included 11 reports consisted of 184 A-P-NBD patients and 114 CP-P-NBD patients. While fever (42% for A-P-NBD, 5% for CP-P-NBD, p < 0.001, I2 = 93%) was more frequently observed in A-P-NBD cases; sphincter disturbances (9%, 34%, P = 0.005, I2 = 87%), ataxia (16%, 57%, P < 0.001, I2 = 92%), dementia (7%, 61%, P < 0.001, I2 = 97%), confusion (5%, 18%, P = 0.04, I2 = 76%), brain stem atrophy on MRI (4%, 75%, P < 0.001, I2 = 98%), and abnormal MRI findings in cerebellum (7%, 54%, P = 0.02, I2 = 81%) were more common in CP-P-NBD. Cerebrospinal fluid cell count (94/mm3, 11/mm3, P = 0.009, I2 = 85%) was higher in A-P-NBD cases. We demonstrated that A-P-NBD and CP-P-NBD had clearly different clinical features and believe that these data will help future studies investigating P-NBD.

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“…In addition, independent factors of maintenance response were older age at diagnosis (≥ 40 years), female sex, a longer disease duration (≥ 5 years), concomitant immunomodulator use, and achievement of remission at week 4 on multivariate analysis ( Table 2 ) [ 45 ]. In a prospective open-label, single-arm phase 3 study in Japan, 18 patients with BD were enrolled, including 11 patients with intestinal BD, three patients with neurological BD, and four patients with vascular BD with poor response or resistance to conventional therapy [ 47 ]. Induction infliximab therapy was administered at 5 mg/kg at weeks 0, 2, and 6, with maintenance therapy every 8 weeks thereafter until week 46.…”

Section: Medical Treatmentmentioning

confidence: 99%

Updated treatment strategies for intestinal Behçet’s disease

Park

Cheon

2018

Korean J Intern Med

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Behçet’s disease (BD) is a chronic, idiopathic, relapsing immune-mediated disease involving multiple organs, and is characterized by recurrent oral and genital ulcers, ocular disease, gastrointestinal ulcers, vascular diseases, and skin lesions. In particular, gastrointestinal involvement in BD is followed by severe complications, including massive bleeding, bowel perforation, and fistula, which can lead to significant morbidity and mortality. However, the management of intestinal BD has not yet been properly established. Intestinal BD patients with a severe clinical course experience frequent disease aggravations and often require recurrent corticosteroid and/or immunomodulatory therapies, or even surgery. However, a considerable number of patients with intestinal BD are often refractory to conventional therapies such as corticosteroids and immunomodulators. Recently, there has been a line of evidence suggesting that biologics such as infliximab and adalimumab are effective in treating intestinal BD. Moreover, new biologics targeting proteins other than tumor necrosis factor α are emerging and are under active investigation. Therefore, in this paper, we review the current therapeutic strategies and new clinical data for the treatment of intestinal BD.

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Infliximab therapy for intestinal, neurological, and vascular involvement in Behcet disease

Cited by 80 publications

References 31 publications

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial

Distinct clinical features between acute and chronic progressive parenchymal neuro-Behçet disease: meta-analysis

Updated treatment strategies for intestinal Behçet’s disease

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