PURPOSE - We performed pooled analyses from 3 small, clinical trials of tanezumab in patients with urologic chronic pelvic pain, including chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and interstitial cystitis/bladder pain syndrome (IC/BPS), to identify patient subpopulations more likely to benefit from tanezumab treatment.
MATERIALS AND METHODS - Pooled analyses included data from 208 patients with IC/BPS or CP/CPPS randomized to placebo (n=104; 65 [62. 5%] female) or tanezumab (n=104; 63 [60. 6%] female; study A4091010 [IC/BPS]: tanezumab 200 μg/kg intravenous (IV); study A4091019 [CP/CPPS]: tanezumab 20 mg IV; study A4091035 [IC/BPS]: tanezumab 20 mg subcutaneous) who received ≥1 dose of study medication. Primary study endpoints were evaluated using analysis of covariance with gender, study and baseline pain as covariates.
RESULTS - For pooled analyses, least squares mean change (standard error) from baseline in 24-hour pain intensity vs. placebo was -0. 60 (0. 24, 90% confidence interval, -0. 99, -0. 20) overall and -0. 99 (0. 32, p=0. 002) and -0. 17 (0. 36, p=0. 650) for females and males, respectively. The improvement in pain intensity was significant (p=0. 011) for patients with symptoms suggesting concomitant presence of non-urological associated somatic syndromes but not for those with pelvic pain symptoms only (p=0. 507).
CONCLUSIONS - Women with IC/BPS and patients with symptoms suggesting concomitant presence of non-urological associated somatic syndromes were more likely to experience significant pain reduction with tanezumab than with placebo therapy. In contrast, no difference was reported in response between tanezumab and placebo therapy for men with CP/CPPS symptoms only.
The Journal of urology. 2015 Nov 11 [Epub ahead of print]
J Curtis Nickel, Ian W Mills, Tim J Crook, Anamaria Jorga, Michael D Smith, Gary Atkinson, John N Krieger
Queen's University, Kingston, Ontario, Canada. Pfizer Ltd, Tadworth, Surrey, UK. , Pfizer Ltd, Tadworth, Surrey, UK. , Pfizer Inc, New York, New York. , Pfizer Inc, New York, New York. , Pfizer Ltd, Tadworth, Surrey, UK. , University of Washington, Seattle, Washington.