title: A randomized, double-blind, placebo controlled trial of adalimumab for interstitial cystitis/bladder pain syndrome.
abstract: OBJECTIVE
  The efficacy of adalimumab for the treatment of interstitial cystitis/bladder pain syndrome was investigated in a phase III, randomized, double-blind, placebo controlled, proof of concept study.
  
  
  METHODS
  Patients with interstitial cystitis/bladder pain syndrome were randomized to receive a loading dose of 80 mg subcutaneous adalimumab followed by 40 mg every 2 weeks or subcutaneous placebo for 12 weeks, and outcome measures were assessed. The incidence of adverse events was also assessed.
  
  
  RESULTS
  Of a total of 43 patients 21 received adalimumab and 22 received placebo. Of the 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 Symptom Scale (p = 0.0017) at 12 weeks compared to baseline. At 12 weeks 11 of 21 (53%) patients in the adalimumab group had a 50% or greater 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 resulted in 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.
authors.affiliation: Department of Urology, Palomar Medical Center, Escondido, California. Electronic address: pboschmd@gmail.com.
authors.forename: Philip C
authors.initials: PC
authors.lastname: Bosch
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D018856:Cystitis, Interstitial / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab
keywords: GRA; IC/BPS; ICPI; ICSI; Interstitial Cystitis Problem Index; Interstitial Cystitis Symptom Index; O'Leary-Sant Interstitial Cystitis Symptom Index and Problem Index; OSPI; PUF; Pelvic Pain, Urgency, Frequency Symptom Scale; TNF-α; adalimumab; autoimmune diseases; cystitis; global response assessment; interstitial; interstitial cystitis/bladder pain syndrome; tumor necrosis factor-alpha; tumor necrosis factor-α