Tanezumab significantly reduces pain in IC

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webslave
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Tanezumab significantly reduces pain in IC

Post by webslave »

J Urol. 2011 May;185(5):1716-21. Epub 2011 Mar 21.

Proof of concept trial of tanezumab for the treatment of symptoms associated with interstitial cystitis.

Evans RJ, Moldwin RM, Cossons N, Darekar A, Mills IW, Scholfield D.
Department of Urology, Wake Forest University, Winston-Salem, North Carolina.


PURPOSE: In this randomized, double-blind, placebo controlled phase 2 study we investigated tanezumab, a humanized monoclonal antibody that specifically inhibits nerve growth factor as a treatment for interstitial cystitis pain.

MATERIALS AND METHODS: Patients with interstitial cystitis received a single intravenous dose of 200 μg/kg tanezumab or placebo. Patients recorded daily pain scores (on an 11-point numerical rating scale) 7 days before attending study visits and completed a urinary symptom diary for 3 of those days. Patients also completed the Interstitial Cystitis Symptom Index questionnaire and a global response assessment. The primary end point was change in average daily numerical rating scale pain score from baseline to week 6. Secondary end points included global response assessment, Interstitial Cystitis Symptom Index score, micturition and urgency episode frequency per 24 hours, and mean voided volume per micturition. The incidence of adverse events was also assessed.

RESULTS: A total of 34 patients received tanezumab and 30 received placebo. At week 6 tanezumab produced a significant reduction from baseline in average daily pain score vs placebo (treatment difference [LS mean, 90% CI] was -1.4 [-2.2, -0.5]). A significantly higher proportion of patients on tanezumab responded as improved in the global response assessment and tanezumab also significantly reduced urgency episode frequency vs placebo. Tanezumab had no significant effect on Interstitial Cystitis Symptom Index score, micturition frequency or mean voided volume per micturition. The most common adverse events were headache (tanezumab 20.6%, placebo 16.7%) and paresthesia (tanezumab 17.6%, placebo 3.3%).

CONCLUSIONS: Tanezumab has shown preliminary efficacy in the treatment of pain associated with interstitial cystitis.

PMID: 21420111
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gmccormack
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Re: Tanezumab significantly reduces pain in IC

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I was in this trial and Pfizer took it out of their pipeline because a small subset of patients got worse. Subsequently, 2 other big pharma took it out of their pipeline when the FDA started asking questions. The only company left in this realm is Abbot labs with one in phase I.

Stepping away from CPPS this was big news in the pain mngt world, apparently many people had great relief from anti NGF drugs but it appears to be just another good idea that won't see the light of day.

I had slight or no improvement while in the trial, however, I could've been in the placebo group. A woman with IC who was in the study with me and had gone earlier was begging the Dr not to let "them" take the drug away because it gave her life back...oh well.
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Re: Tanezumab significantly reduces pain in IC

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The FDA arthritis committee was originally going to hold a meeting on september 13th, 2011. This meeting is currently postponed because a large amount of data was submitted to the committee that needs time to be reviewed. The date of the next hearing on the clinical hold on Anti-ngf drugs will be announced at a later date. That is to say, we are currently waiting to be told when they are going to talk about what they're going to do with the fate of anti-ngf drugs.

Here's the whole story
http://www.fda.gov/AdvisoryCommittees/C ... 263496.htm
Age:19 | Onset Age:19. July 7th, 2011. | Symptoms: burning testicular pain, burning perineal pain, poor range of motion in right hip flexor, post ejaculatory pain (usually), decreased libido, depression | Helped By: narcotic pain killers, stretching (not sure) | Worsened By: alcoholic beverages, mostly unsure what effects my symptoms for better or worse.
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Re: Tanezumab significantly reduces pain in IC

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Urology. 2012 Sep 22. pii: S0090-4295(12)00857-6. doi: 10.1016/j.urology.2012.07.035.
Preliminary Assessment of Safety and Efficacy in Proof-of-Concept, Randomized Clinical Trial of Tanezumab for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Nickel JC, Atkinson G, Krieger JN, Mills IW, Pontari M, Shoskes DA, Crook TJ.
Department of Urology, Queen's University, Kingston, Ontario, Canada.


OBJECTIVE: To assess the efficacy and safety of tanezumab, a humanized monoclonal antibody directed against the pain-mediating neurotrophin, nerve growth factor, to treat pain and other symptoms of chronic prostatitis/chronic pelvic pain syndrome in a Phase IIa, proof-of-concept clinical trial powered to provide 2-sided 90% confidence interval around the primary endpoint.

METHODS: Patients received a single intravenous dose of tanezumab (20 mg) or placebo. The primary efficacy endpoint was the change from baseline to week 6 in average daily numerical rating scale pain score. The secondary endpoints included the change from baseline to week 6 in the National Institutes of Health Chronic Prostatitis Symptom Index and urinary symptoms. Safety was also assessed.

RESULTS: Overall, 62 patients were randomized (30 to tanezumab and 32 to placebo). At week 6, tanezumab marginally improved the average daily pain (least-squares mean difference from placebo -0.47, 90% confidence interval -1.150-0.209) and urgency episode frequency (least-squares mean difference from placebo -1.37, 90% confidence interval -3.146-0.401). No difference was seen in the National Institutes of Health chronic prostatitis symptom index total score or micturition frequency at week 6. The most common adverse events were paresthesia and arthralgia. The odds of having a ≥30% reduction in pain were 1.75-fold greater (90% confidence interval 0.65-4.69) for patients receiving tanezumab versus placebo.

CONCLUSION: Tanezumab might improve symptoms for some patients with chronic prostatitis/chronic pelvic pain syndrome. Although proof of concept was not demonstrated in the present study, additional studies with larger populations and stricter inclusion criteria according to patient phenotype might identify populations in which antinerve growth factor treatment will provide clinical benefit.

PMID: 23010344
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Re: Tanezumab significantly reduces pain in IC

Post by gmccormack »

This might be old news to some but Tanezumab is back in the pipeline and being expedited by the FDA. Apparently, the people whose arthritis got worse were ones where pain was completely eliminated and the patients thought they could go back to an active lifestyle.

I am pretty sure its being expedited for terminal cancer pain patients and I asked my PM doc more about it and it could be that insurance will not cover it for off label use. Who knows.
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Re: Tanezumab significantly reduces pain in IC

Post by Wolfcub »

Indeed. From Wikipedia (source is not mentioned there):
"In march of 2012 the Anti-NGF Testing - FDA Committee voted in favor of a continuation of the development of nerve-blocking medications, as long as certain safety precautions were observed."
Many of them were terminated, though.
http://www.clinicaltrials.gov/ct2/resul ... ab&phase=1
Age: 30 | Onset Age: 19| Symptoms: Urinary frequency, Urinary urgency, constant 24/7 sensation in the penis (in the tip mainly - burning/pressure/discomfort/"wetness"), Nocturia, discomfort and pressure in the pelvic region radiating to the abdomen and becoming severe as time passes since last urination (resolved in 2014 by myofascial release), Stream velocity is somewhat slow and prolonged with an average velocity of ~13cc/min (and max 18cc/min) found in flowmetry test when bladder is filled with 500cc at age 25 (I always feel like I need to press my abdomen to urinate, improved later on when using alpha blockers)| Helped By: especially MYOFASCIAL RELEASE (especially in the areas of hips and abdomen) - generally resolved my abdominal aches, but penile symptoms remained the same| Worsened By: Coffee and possibly some other food as well| Other comments: Quercetin and acupuncture helped me no more than a placebo effect. Age 25-26: Diagnosed with indirect inguinal hernia and medium hydrocele at the same side. After operation many of the acute symptoms disappeared, but the chronic urinary and pelvic symptoms remained much the same.
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