Arthritis & Rheumatism, Volume 63,
November 2011 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Chicago, Illinois November 4-9, 2011.
Adverse Events of Immunosuppressive Therapy in Autoimmune Uveitis Patients.
Rosales, Zulema, Rodriguez-Cambron, Ana B., Fontsere, Oscar, Leon, Leticia, Arriola, Pedro, Abasolo, Lydia, Martinez, Cristina
Uveitis is the inflammation of the uveal tract. An immune-mediated inflammatory mechanism is the main cause of the uveitis. Non infectious autoimmune uveitis might develop a severe course with poor visual prognosis if an adequate control of the disease is not achieved. Corticosteroids (CE) are central to control acute and severe ocular inflammation and immunosuppressive drugs (IS) are used when CE are insufficient. There are no published large series and long follow-up on the effects of IS in uveitis.
Our purpose was to analyze the incidence of side effects and the withdrawal rate of the IS in a cohort of patients with autoimmune uveitis attended at the uveitis unit in our hospital.
A retrospective study from January 1992 to October 2010 was performed. Study was approved by the Ethic Committee of our hospital.
The inclusion criteria were diagnosis of chronic anterior uveitis, intermediate uveitis, posterior uveitis and panuveitis who received one of the following IS: cyclosporine A (CSA), methotrexate (MTX), azathioprine (AZA), cyclophosphamide, mycophenolate mofetil, Infliximab, Adalimumab (ADA) and/or Etanercept. We analyze IS cycles used, survival time after treatment, adverse events (AE) during the follow-up and visual acuity (VA) at baseline and last ophthalmological assessment. Survival techniques were used to estimate the incidence rate (IR) and 95% confidence interval [95% IC] of adverse events and discontinuation by drug exposure. Descriptive and bivariate analyses were also performed with Stata package.
1535 patients were evaluated in the uveitis unit during the follow up (18.9 years). 75 patients met the inclusion criteria, 41 were women (54.7%) and the mean age at diagnosis of uveitis was 42 ± 19.7 years. 23 patients had any AE. A total of 38 AE were collected during follow-up (14 digestive intolerance, 11 increase of creatinine level, 5 liver toxicity, 5 hypertension, 2 cytopenias and 1 bronchospasm) with an incidence of 6.42% (95% CI 4.67 to 8.82) during follow-up. There were no differences between men and women in the development of AE (p = 0.43). The risk of an AE increased with increasing age of patients (p = 0.02). Table 1 shows the IR per 100 patients-years (95% IC) of AE and drug discontinuation by drug exposure. There was an improvement in VA in both eyes in the follow-up: mean change (±SD) right eye 0.11 ± 0.35 and left eye 0.10 ± 0.51.
|Drug||N° of patients with the drug||N° of patients with AE||IR of AE by drug exposure||N° of withdrawals||IR of discontinuation by drug exposure|
|MTX||37||6||2.9 (1.36.5)||3||1.5 (0.54.5)|
|CSA||46||22||9.3 (6.114.1)||8||3.3 (1.76.7)|
|AZA||29||9||6.3 (3.312.2)||7||4.9 (2.310.3)|
|ADA||3||1||33.3 (4.7236.2)||1||33.3 (4.7236.2)|
The use of IS for the treatment of ocular inflammatory disease, particularly uveitis refractory to CE, is an effective and necessary alternative treatment. In our series, the incidence rate of AE of IS and the rate of discontinuation are low. Although the safety profile of IS used is good, it is essential to maintain a continuous monitoring during treatment. The VA in this group of patients is maintained during the follow-up.
To cite this abstract, please use the following information:
Rosales, Zulema, Rodriguez-Cambron, Ana B., Fontsere, Oscar, Leon, Leticia, Arriola, Pedro, Abasolo, Lydia, et al; Adverse Events of Immunosuppressive Therapy in Autoimmune Uveitis Patients. [abstract]. Arthritis Rheum 2011;63 Suppl 10 :1042