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* = Presenting author

P656 Infliximab therapy for intestinal, neuro-, and vascular Behcet disease: efficacy, safety, and pharmacokinetics in a multicentre prospective study

T. Hibi*1, S. Hirohata2, H. Kikuchi3, U. Tateishi4, N. Sato5, K. Ozaki5, K. Kondou5, Y. Ishigatsubo6

1Kitasato University Kitasato Institute Hospital, Centre for Advanced IBD Research and Treatment, Tokyo, Japan, 2Kitasato University School of Medicine, Department of Rheumatology and Infectious Diseases, Sagamihara, Japan, 3Teikyo University School of Medicine, Department of Internal Medicine, Tokyo, Japan, 4Tokyo Medical and Dental University Graduate School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, Tokyo, Japan, 5Mitsubishi Tanabe Pharma Corporation, Osaka, Japan, 6Yokohama City University, Yokohama, Japan

Background

Behcet disease (BD) is a multisystem disease characterised by mucocutaneous, ocular, gastrointestinal, neurologic, or vascular manifestations. Even though involvement of the gastrointestinal tract, central nervous system, and vessels is rare, such cases tend to have a poor prognosis. Here, we conducted a multicentre, prospective clinical trial to clarify the efficacy, safety, and pharmacokinetics of infliximab (IFX) in patients with intestinal, neuro-, and vascular BD with poor response or intolerance to conventional therapy (ClinicalTrials.gov NCT01532570).

Methods

IFX at 5 mg/kg was administered to 18 (11 intestinal, 3 neuro-, and 4 vascular) BD patients at weeks 0, 2, and 6, and then every 8 weeks thereafter until week 46. In those who lost response to IFX after week 30, dose was increased to 10 mg/kg. We then calculated the percentage of complete responders based on clinical symptoms specific to each disease type or results of examinations (endoscopy, magnetic resonance imaging, spinal fluid, or sera), with percentage of complete responders at week 30 set as the primary endpoint. Patient visual analogue scale, Short Form 36 score, and the oral steroid dosage were also assessed.

Results

The percentage of complete responders was 61% (11/18) at both weeks 14 and 30 and remained the same until week 54. The percentage of intestinal BD patients with no clinical symptoms was 36% (4/11) at week 2, and gradually increased thereafter (Figure 1). Principal ulcer was cured or scarred in more than 80% of patients after week 14, and serum C-reactive protein (CRP) levels either decreased or remained low from week 2 in most patients. Though the number of neuro-BD patients was small, we still detected marked improvements in clinical symptoms and imaging and spinal fluid findings. In vascular BD patients, clinical symptoms improved after week 2, and CRP levels and the erythrocyte sedimentation rate decreased. In 3 of the 4 vascular BD patients, imaging findings showed inflammation suppression. Regardless of BD type, quality of life improved in all patients at the end of the study, and steroid dosage had either been reduced or usage was withdrawn entirely. IFX dose was increased to 10 mg/kg in 3 intestinal BD patients, and consequently, the clinical symptoms, CRP level, and quality of life improved. The profiles of safety and pharmacokinetics were comparable to those in patients with rheumatoid arthritis or Crohn’s disease.

Figure Efficacy of IFX for intestinal BD; A) percentage with improved or cured clinical symptoms and B) changes in size of principal ulcer in individual patients.

Conclusion

These findings support IFX as a new therapeutic option for patients with intestinal, neuro-, or vascular BD.