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Tanezumab Reduces Pain in Women with Interstitial Cystitis/Bladder Pain Syndrome and Patients with Nonurological Associated Somatic Syndromes

2015; Lippincott Williams & Wilkins; Volume: 195; Issue: 4 Part 1 Linguagem: Inglês

10.1016/j.juro.2015.10.178

1527-3792

J. Curtis Nickel, Ian Mills, Tim Crook, Anamaria Jorga, Michael D. Smith, Gary Atkinson, John N. Krieger,

Pelvic floor disorders treatments

No AccessJournal of UrologyAdult Urology1 Apr 2016Tanezumab Reduces Pain in Women with Interstitial Cystitis/Bladder Pain Syndrome and Patients with Nonurological Associated Somatic Syndromes J. Curtis Nickel, Ian W. Mills, Tim J. Crook, Anamaria Jorga, Michael D. Smith, Gary Atkinson, and John N. Krieger J. Curtis NickelJ. Curtis Nickel Queen's University, Kingston, Ontario, Canada , Ian W. MillsIan W. Mills Pfizer Ltd, Tadworth, Surrey, United Kingdom , Tim J. CrookTim J. Crook Pfizer Ltd, Tadworth, Surrey, United Kingdom , Anamaria JorgaAnamaria Jorga Pfizer Inc, New York, New York , Michael D. SmithMichael D. Smith Pfizer Inc, New York, New York , Gary AtkinsonGary Atkinson Pfizer Ltd, Tadworth, Surrey, United Kingdom , and John N. KriegerJohn N. Krieger University of Washington, Seattle, Washington View All Author Informationhttps://doi.org/10.1016/j.juro.2015.10.178AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: 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. Materials and 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. References 1 : Words of wisdom. Re: Clinical phenotyping in chronic prostatitis/chronic pelvic pain syndrome and interstitial cystitis: a management strategy for urologic chronic pelvic pain syndromes. Eur Urol2009; 56: 881. Google Scholar 2 : Diagnosis and treatment of chronic abacterial prostatitis: a systematic review. Ann Intern Med2000; 133: 367. Google Scholar 3 : Pentosan polysulfate sodium for therapy of interstitial cystitis. A double-blind placebo-controlled clinical study. Urology1990; 35: 552. 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Volume 195Issue 4 Part 1April 2016Page: 942-948Supplementary Materials Advertisement Copyright & Permissions© 2016 by American Urological Association Education and Research, Inc.Keywordspelvic painprostatitisnerve growth factortanezumabcystitisinterstitialAcknowledgmentsEditorial support was provided by Joseph Oleynek of Engage Scientific Solutions and funded by Pfizer. The authors are grateful to the study investigators and the patients who participated in the studies.MetricsAuthor Information J. Curtis Nickel Queen's University, Kingston, Ontario, Canada More articles by this author Ian W. Mills Pfizer Ltd, Tadworth, Surrey, United Kingdom More articles by this author Tim J. Crook Pfizer Ltd, Tadworth, Surrey, United Kingdom More articles by this author Anamaria Jorga Pfizer Inc, New York, New York More articles by this author Michael D. Smith Pfizer Inc, New York, New York Financial interest and/or other relationship with Pfizer. Current affiliation: Astellas Inc. More articles by this author Gary Atkinson Pfizer Ltd, Tadworth, Surrey, United Kingdom More articles by this author John N. Krieger University of Washington, Seattle, Washington More articles by this author Expand All Advertisement PDF downloadLoading ...