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Autoimmune Clinical Manifestations following Intravesical Bacillus Calmette-Guérin and Interferon alpha 2b Immunotherapy for Superficial Bladder Cancer

Autoimmune Clinical Manifestations following Intravesical Bacillus Calmette-Guérin and Interferon... Objective: To determine the incidence and type of autoimmune clinical manifestations associated with intravesical bacillus Calmette-Guérin (BCG) and interferon alpha 2b (INF-α2b) immunotherapy in our department’s recently completed national clinical trial. Patient and Methods: One hundred and forty patients were recruited in our department’s national clinical trial from May 1995 to April 2004. Following strict inclusion criteria patients were recruited, counselled and then randomized to receive either full dose BCG (81 mg, Arm A) or 1/3 dose BCG (27 mg, Arm B) or 1/3 dose BCG (27mg) with 10 million units of INF-α2b (Arm C) intravesically. We report on autoimmune clinical manifestations seen in 8 patients (6%). These clinical manifestations include arthritis, arthralgia, iritis and uveitis seen with the different arms of intravesical treatment. The aim of the paper is to highlight the autoimmune clinical manifestations associated with BCG and INF-α2b immunotherapy. We will in due course publish the details of clinical efficacy of different arms of treatment in our clinical trial. Results: Mean number of instillations at time of autoimmune manifestations was 6. All patients developed autoimmune clinical manifestations within 7 days of intravesical installation. Four patients had red eye (2 uveitis and 2 iritis). Symmetrical polyarthritis was common (6/8). The main joints affected were knee (62%) and shoulder (38%). Acute phase reactants were elevated during the onset of symptoms. Anti-inflammatory therapy was effective in 60% of patients. The incidences of autoimmune symptoms were 11% with Arm C followed by 10% with Arm B and 6% with Arm A. Conclusions: The autoimmune clinical manifestations associated with intravesical BCG and INF-α2b are often acute in onset following intravesical installation. Serum acute phase reactants are commonly elevated during the onset of symptoms. Our data suggests that pre-instillation prophylactic anti-inflammatory therapy may be useful in prevention of autoimmune clinical manifestation following BCG ± INF-α2b intravesical immunotherapy. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Current Urology Karger

Autoimmune Clinical Manifestations following Intravesical Bacillus Calmette-Guérin and Interferon alpha 2b Immunotherapy for Superficial Bladder Cancer

Vasdev, Nikhil; Esuvaranathan, Kesavan
Current Urology , Volume 3 (1): 5 – Jan 1, 2009
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Publisher
Karger
Copyright
© 2009 S. Karger AG, Basel
ISSN
1661-7649
eISSN
1661-7657
DOI
10.1159/000189679
Publisher site
See Article on Publisher Site

Abstract

Objective: To determine the incidence and type of autoimmune clinical manifestations associated with intravesical bacillus Calmette-Guérin (BCG) and interferon alpha 2b (INF-α2b) immunotherapy in our department’s recently completed national clinical trial. Patient and Methods: One hundred and forty patients were recruited in our department’s national clinical trial from May 1995 to April 2004. Following strict inclusion criteria patients were recruited, counselled and then randomized to receive either full dose BCG (81 mg, Arm A) or 1/3 dose BCG (27 mg, Arm B) or 1/3 dose BCG (27mg) with 10 million units of INF-α2b (Arm C) intravesically. We report on autoimmune clinical manifestations seen in 8 patients (6%). These clinical manifestations include arthritis, arthralgia, iritis and uveitis seen with the different arms of intravesical treatment. The aim of the paper is to highlight the autoimmune clinical manifestations associated with BCG and INF-α2b immunotherapy. We will in due course publish the details of clinical efficacy of different arms of treatment in our clinical trial. Results: Mean number of instillations at time of autoimmune manifestations was 6. All patients developed autoimmune clinical manifestations within 7 days of intravesical installation. Four patients had red eye (2 uveitis and 2 iritis). Symmetrical polyarthritis was common (6/8). The main joints affected were knee (62%) and shoulder (38%). Acute phase reactants were elevated during the onset of symptoms. Anti-inflammatory therapy was effective in 60% of patients. The incidences of autoimmune symptoms were 11% with Arm C followed by 10% with Arm B and 6% with Arm A. Conclusions: The autoimmune clinical manifestations associated with intravesical BCG and INF-α2b are often acute in onset following intravesical installation. Serum acute phase reactants are commonly elevated during the onset of symptoms. Our data suggests that pre-instillation prophylactic anti-inflammatory therapy may be useful in prevention of autoimmune clinical manifestation following BCG ± INF-α2b intravesical immunotherapy.

Journal

Current Urology – Karger

Published: Jan 1, 2009

Keywords: Bacillus Calmette-Guérin; Interferon alpha 2b; Autoimmunity; Bladder cancer

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