PURPOSE: The efficacy of adalimumab in the treatment of interstitial cystitis/bladder pain syndrome was investigated in a phase III, randomized, double blind, placebo controlled, proof of concept study.
MATERIALS AND METHODS: Interstitial cystitis/bladder pain syndrome patients were randomized to receive SQ adalimumab 80 mg loading dose followed by 40 mg every 2 weeks or SQ placebo for 12 weeks and outcome measures were assessed. Incidences of adverse events were assessed.
RESULTS: Of the 43 patients, 21 received adalimumab and 22 received placebo. Of patients who received adalimumab, there was a statistically significant improvement demonstrated in the O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (p = 0.0002), Interstitial Cystitis Symptom Index (p = 0.0011), Interstitial Cystitis Problem Index (p = 0.0002), and Pelvic Pain, Urgency, Frequency scale (p = 0.0017) at 12 weeks compared to baseline. At 12 weeks 11 of 21 (53%) of the adalimumab group had a ≥ 50% improvement in global response assessment (p = ≤ 0.0001). There was not a statistically significant improvement in any outcome measure in patients receiving adalimumab compared to placebo. There were no significant adverse events.
CONCLUSIONS: Adalimumab treatment demonstrated a statistically significant improvement in outcome measures compared to baseline in patients with moderate to severe interstitial cystitis/bladder pain syndrome. Adalimumab failed to demonstrate positive proof of concept compared to placebo due to a significant placebo effect.
Written by:
Bosch PC. Are you the author?
Department of Urology, Palomar Medical Center, Escondido, California.
Reference: J Urol. 2013 Jun 20. pii: S0022-5347(13)04649-1.
doi: 10.1016/j.juro.2013.06.038
PubMed Abstract
PMID: 23792149
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