Adalimumab for the Treatment of Japanese Patients With Intestinal Behçet’s Disease

Tanida, Satoshi; Inoue, Nagamu; Kobayashi, Kiyonori; Naganuma, Makoto; Hirai, Fumihito; Iizuka, Bunei; Watanabe, Kenji; Mitsuyama, Keiichi; Inoue, Takuya; Ishigatsubo, Yoshiaki; Suzuki, Yasuo; Nagahori, Masakazu; Motoya, Satoshi; Nakamura, Shirô; Arora, Vipin; Robinson, Anne; Thakkar, Roopal; Hibi, Toshifumi

doi:10.1016/j.cgh.2014.08.042

Cited by 94 publications

(117 citation statements)

References 28 publications

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“…Our present findings for IFX were comparable to previous findings from studies using other TNF inhibitors, such as adalimumab [21] or etanercept, [22] in terms of efficacy against intestinal BD. Healing or scarring of the principal ulcer was achieved in more than 80% of such patients in the present study, suggesting that IFX has potent mucosal healing effects.…”

Section: Discussionsupporting

confidence: 91%

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

et al. 2016

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Behçet disease (BD) is a multisystem disease associated with a poor prognosis in cases of gastrointestinal, neurological, or vascular involvement. We conducted a multicenter, prospective, open-label, single-arm phase 3 study to determine the efficacy, safety, and pharmacokinetics of infliximab (IFX) in BD patients with these serious complications who had displayed poor response or intolerance to conventional therapy.IFX at 5 mg/kg was administered to 18 patients (11 intestinal BD, 3 neurological BD [NBD], and 4 vascular BD [VBD]) at weeks 0, 2, and 6 and every 8 weeks thereafter until week 46. In patients who showed inadequate responses to IFX after week 30, the dose was increased to 10 mg/kg. We then calculated the percentage of complete responders according to the predefined criteria depending on the symptoms and results of examinations (ileocolonoscopy, brain magnetic resonance imaging, computed tomography angiography, positron emission tomography, cerebrospinal fluid, or serum inflammatory markers), exploring the percentage of complete responders at week 30 (primary endpoint).The percentage of complete responders was 61% (11/18) at both weeks 14 and 30 and remained the same until week 54. Intestinal BD patients showed improvement in clinical symptoms along with decrease in C-reactive protein (CRP) levels after week 2. Consistently, scarring or healing of the principal ulcers was found in more than 80% of these patients after week 14. NBD patients showed improvement in clinical symptoms, imaging findings, and cerebrospinal fluid examinations. VBD patients showed improvement in clinical symptoms after week 2 with reductions in CRP levels and erythrocyte sedimentation rate. Imaging findings showed reversal of inflammatory changes in 3 of the 4 VBD patients. Irrespective of the type of BD, all patients achieved improvement in quality of life, leading to the dose reduction or withdrawal of steroids. IFX dose was increased to 10 mg/kg in 3 intestinal BD patients, resulting in the improvement of clinical symptoms, CRP levels, and visual analogue scale score. Safety and pharmacokinetics profiles were comparable to those in patients with rheumatoid arthritis or Crohn disease. These findings support IFX as a new therapeutic option for patients with intestinal BD, NBD, or VBD.

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Section: Discussionsupporting

confidence: 91%

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

et al. 2016

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“…As we know, most of the studies and case reports in the literature show that adalimumab is an effective treatment agent on erythema nodosum [24][25][26][27][28][29]. Contrary to these findings, we think that our case is the first report of idiopathic transient erythema nodosum during adalimumab therapy.…”

Section: Discussioncontrasting

confidence: 51%

Erythema Nodosum During Adalimumab Therapy: An Idiopathic Transient Paradoxical Effect

Ilhanli¹

2015

AJIM

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Contrary to their undoubted efficacy on rheumatologic diseases, potential for developing skin lesions with Tumor necrosis alpha blockers (Anti-TNF alpha) is an important question in our minds. Although we know, most of the studies and case reports in the literature show that adalimumab is an effective treatment agent on erythema nodosum, we should keep in mind this lesion as a rare paradoxical side-effect. Here we present a case of idiopathic transient erythema nodosum during adalimumab therapy.

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“…In this study, authors started the treatment at a dose of 160 and 80 mg 2 weeks later, followed by 40 mg every other week. Sixtyone percent of patients were able to discontinue steroids in 1 year, and 20 % of patients achieved complete remission [82]. There are also reports of NBD patients that respond to adalimumab [67].…”

Section: Prevention Of Relapsesmentioning

confidence: 96%

Behçet’s Disease and Nervous System Involvement

Kürtüncü

Tüzün

Akman‐Demir

2016

Curr Treat Options Neurol

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Management of neuro-Behçet's disease can be divided into two stages: treatment of acute attacks and prevention of relapses. Treatment of acute attacks is accomplished by high-dose intravenous corticosteroids followed by maintenance treatment with oral steroids for 6-12 months depending on the type and severity of the neurological involvement. Relapses can be prevented by using immunosuppressants. Oral immunosuppressants such as azathioprine and mycophenolate are the most widely utilized agents for this purpose. Patients who are refractory or who cannot tolerate these medications can be managed by cyclophosphamide, interferon alpha, or anti-TNF-α monoclonal antibodies such as infliximab, etanercept, and adalimumab. Recent reports showed that newer agents such as tocilizumab, canakinumab, and anakinra, which exert their biological activity through IL-1 and IL-6 pathways, are also promising treatment alternatives for progressive or relapsing patients.

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Adalimumab for the Treatment of Japanese Patients With Intestinal Behçet’s Disease

Abstract: Adalimumab is a potentially effective treatment for intestinal Behçet's disease in Japanese patients who are refractory to conventional treatments. ClinicalTrials.gov number: NCT01243671.

Cited by 94 publications

References 28 publications

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

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

Erythema Nodosum During Adalimumab Therapy: An Idiopathic Transient Paradoxical Effect

Behçet’s Disease and Nervous System Involvement

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