title: Tanezumab Reduces Pain in Women with Interstitial Cystitis/Bladder Pain Syndrome and Patients with Nonurological Associated Somatic Syndromes.
abstract: OBJECTIVE
  We performed pooled analyses from 3 small, clinical trials of tanezumab in patients with urological chronic pelvic pain, including chronic prostatitis/chronic pelvic pain syndrome and interstitial cystitis/bladder pain syndrome, to identify patient subpopulations more likely to benefit from tanezumab treatment.
  
  
  METHODS
  Pooled analyses included data from 208 patients with interstitial cystitis/bladder pain syndrome or chronic prostatitis/chronic pelvic pain syndrome randomized to placebo (104, 65 [62.5%] female) or tanezumab (104, 63 [60.6%] female) who received 1 dose or more of study medication. Data on tanezumab were from study A4091010 (interstitial cystitis/bladder pain syndrome) on 200 μg/kg intravenous, study A4091019 (chronic prostatitis/chronic pelvic pain syndrome) on 20 mg intravenous and study A4091035 (interstitial cystitis/bladder pain syndrome) on 20 mg subcutaneous. Primary study end points were evaluated using analysis of covariance with gender, study and baseline pain as covariates.
  
  
  RESULTS
  For pooled analyses least squares mean (SE) change from baseline in 24-hour pain intensity vs placebo was -0.60 (0.24, 90% CI -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 the concomitant presence of nonurological associated somatic syndromes but not for those with pelvic pain symptoms only (p=0.507).
  
  
  CONCLUSIONS
  Women with interstitial cystitis/bladder pain syndrome and patients with symptoms suggesting the concomitant presence of nonurological 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 chronic prostatitis/chronic pelvic pain syndrome symptoms only.
authors.affiliation: Queen's University, Kingston, Ontario, Canada. Electronic address: jcn@queensu.ca.
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.affiliation: Pfizer Ltd, Tadworth, Surrey, United Kingdom.
authors.forename: Ian W
authors.initials: IW
authors.lastname: Mills
authors.affiliation: Pfizer Ltd, Tadworth, Surrey, United Kingdom.
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Crook
authors.affiliation: Pfizer Inc, New York, New York.
authors.forename: Anamaria
authors.initials: A
authors.lastname: Jorga
authors.affiliation: Pfizer Inc, New York, New York.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Smith
authors.affiliation: Pfizer Ltd, Tadworth, Surrey, United Kingdom.
authors.forename: Gary
authors.initials: G
authors.lastname: Atkinson
authors.affiliation: University of Washington, Seattle, Washington.
authors.forename: John N
authors.initials: JN
authors.lastname: Krieger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017699:Pelvic Pain / Q000188:drug therapy*; D020886:Somatosensory Disorders / Q000188:drug therapy*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; C549319:tanezumab
keywords: cystitis; interstitial; nerve growth factor; pelvic pain; prostatitis; tanezumab