Rituximab in intractable ocular lesions of Behcet's disease; randomized single-blind control study (pilot study).
BACKGROUND
Ocular lesions, the main morbidity of Behcet's disease (BD), are the most difficult to treat. The aim of this study was to evaluate the efficacy of rituximab.


METHODS
Inclusion criteria were retinal vasculitis and edema, resistant to cytotoxic drugs. Twenty patients were randomized to a rituximab group (RG) or cytotoxic combination therapy group (CCTG). Rituximab was given in two 1000-mg courses (15-day interval). Subjects received methotrexate (15 mg/weekly) with prednisolone (0.5 mg/kg per day). The CCTG received pulse cyclophosphamide (1000 mg/monthly), azathioprine (2-3 mg/kg per day) and prednisolone (0.5 mg/kg per day). The primary endpoint was the overall state of patients' eyes and the Total Adjusted Disease Activity Index (TADAI). Secondary endpoints were: visual acuity (VA), posterior uveitis (PU), and retinal vasculitis (RV). The baseline data were compared at 6 months by paired sample t-test and analysis of variance.


RESULTS
TADAI improved significantly in the RG (t = 3.340, P = 0.009), but not in the CCTG (t = 2.241, P = 0.052). For secondary endpoints (RG/CCTG), the mean VA improved in two patients versus three (2/3), remained unchanged in 1/1, and worsened in 7/6 patients. The mean PU improved significantly in the RG (t = 3.943, P = 0.001), not in the CCTG (t = 2.371, P = 0.028). RV improved, but not statistically (t = 2.027, P = 0.057 vs. t = 1.045, P = 0.31). Edema of retina, disc and macula improved significantly in both, but much better for the RG (t = 2.781, P = 0.012 vs. t = 2.707, P = 0.014).


CONCLUSIONS
Rituximab was efficient in severe ocular manifestations of BD, TADAI improved significantly after 6 months with rituximab, but not with CCT.
Davatchi
Fereydoun
F
Behcet's Unit, Rheumatology Research Center, Tehran University of Medical Sciences, Tehran, Iran. fddh@neda.net
Shams
Hormoz
H
Rezaipoor
Mozhgan
M
Sadeghi-Abdollahi
Bahar
B
Shahram
Farhad
F
Nadji
Abdolhadi
A
Chams-Davatchi
Cheyda
C
Akhlaghi
Massoomeh
M
Faezi
Tahereh
T
Naderi
Nasim
N
D000293:Adolescent; D000328:Adult; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use; D001528:Behcet Syndrome / Q000150:complications*; D003520:Cyclophosphamide / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007492:Iran; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D010211:Papilledema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D010865:Pilot Projects; D011239:Prednisolone / Q000627:therapeutic use; D031300:Retinal Vasculitis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D000069283:Rituximab; D012720:Severity of Illness Index; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014606:Uveitis, Anterior / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D015866:Uveitis, Posterior / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014792:Visual Acuity / Q000187:drug effects; D055815:Young Adult
D058846:Antibodies, Monoclonal, Murine-Derived; D007166:Immunosuppressive Agents; D000069283:Rituximab; D003520:Cyclophosphamide; D011239:Prednisolone; D001379:Azathioprine; D008727:Methotrexate