The Therapeutic Role of Isotretinoin in the Management of Behçet's Disease: A Single-Blinded, Controlled Therapeutic Study

April 2013 | Volume 12 | Issue 4 | Original Article | e68 | Copyright © 2013

Khalifa E. Sharquie MD PhD,a Raad M. A. Helmi BDS PhD,b Adil A. Noiami MD DDV FICMS,c Raafa K. Al-Hayani MD DDV,d and Mohand A. A. Kadhom BDS MSce

aScientific Council of Dermatology and Venereology, Iraqi Board for Medical Specializations, Baghdad, Iraq
bDepartment of Oral Medicine, College of Dentistry, Al-Mustansiriya University, Baghdad, Iraq
cDepartment of Dermatology and Venereology, College of Medicine, Baghdad University, Baghdad, Iraq
dDepartment of Dermatology and Venereology, Baghdad Teaching Hospital, Baghdad, Iraq
eDohuk Specialized Dental Center, General Directorate of Health, Dohuk, Kurdistan, Iraq

Abstract

OBJECTIVES: To evaluate the long-term remission efficacy and safety of isotretinoin in the treatment of Behcet's disease (BD).
PATIENTS and METHODS: This single-blind, controlled therapeutic study was conducted in the Department of Dermatology and Venereology at Baghdad Teaching Hospital from February 2011 to January 2012. Thirty patients with BD were included in this work. Each patient received isotretinoin 20 mg orally once daily for 3 months. They were assessed at week 2 and then monthly depending on the Clinical Manifestation Index (CMI) and to record any side effects. At week 12, isotretinoin was stopped and patients were given placebo therapy in a form of glucose capsules for another 3 months.
RESULTS: Thirty patients were treated, 14 (46.6%) males and 16 (53.3%) females, with a male to female ratio of 1:1. Their ages ranged from 16 to 64 years (mean +/- standard deviation [SD], 38.4 +/- 10.9 years). During the first 3 months of therapy, the pathergy test, oral pathergy test, and C-reactive protein were significantly minimized. The CMI before isotretinoin therapy ranged between 2 and 8 (mean +/- SD, 4.933 +/- 1.91). After therapy, within the first 14 days, the mean CMI started to decline to a lower level, and it continued to decline significantly until week 12. It then started to increase through week 4 of placebo therapy, but remained statistically significant until the second month of placebo therapy. Isotretinoin therapy also had a statistically significant effect in reducing oral ulcers and skin manifestations.
CONCLUSION: Isotretinoin is an effective therapeutic and prophylactic drug in the management of BD.

J Drugs Dermatol. 2013;12(4):e68-e73.

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INTRODUCTION

Behçet’s disease (BD) is relatively common in many countries, including Iraq.1 Its etiopathogenesis is not well elucidated, but many factors have been incriminated, such as genetic predisposition, infectious agents, immunological processes, and endothelial cell dysfunction.2 The clinical manifestations of BD are varied, but it can be threatening in terms of ocular, cardiovascular, and central nervous system involvement,3,4 and its management is still a matter of controversy.5

Khalifa E. Sharquie MD introduced dapsone into the management of BD in 1984.6 Since that time, many publications have confirmed the effectiveness of this drug.2,7-9 Moreover, oral zinc sulfate has proved its effectiveness.10 Many other therapeutic agents have been tried, such as corticosteroids,11,12 antimicrobial agents,13 pimecrolimus,14,15 anti-inflammatory agents, anesthetics, and silver nitrate.16-18 However, unfortunately, until now no single curative drug has been available. Accordingly, researchers always are looking for new remedies for BD, and one of these is isotretinoin, which is the subject of the present study.

PATIENTS AND METHODS

Thirty patients who attended the BD clinic in the Department of Dermatology and Venereology at Baghdad Teaching Hospital were enrolled in this single-blinded, controlled therapeutic study from February 2011 to January 2012. A detailed history was taken of their age, sex, occupation, disease history, rate of recurrence, duration, symptoms associated with the ulceration, and interference with swallowing, drinking, or eating. Aggravating factors such as food allergies, stress, and trauma were also evaluated. The subjects were also questioned about their general health, medical history, surgical history, drug history, tobacco history, and occurrence of BD in their families. All patients were subjected to a full examination by a committee of dermatologists, ophthalmologists, neurologists, and dentists.

The following tests were performed on all patients: a pathergy test and oral pathergy test using a 20-gauge needle, human leukocyte antigen (HLA) typing for HLA-B5 and HLA-B27, a complete blood count, erythrocyte sedimentation rate, C-reactive protein (CRP), renal function test, and liver function test. The diagnosis was done according to the international study group criteria for the diagnosis of BD,19 and patients who fulfilled these criteria were included in this study. Behçet’s disease patients with the following manifestations were included in the trial: 1) mucocutaneous manifestations and 2) joint involvement (arthritis/ arthralgia). Patients on systemic steroids were tapered off

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