Evidence map›Paper›PMID 30936738›Full record

ArticleJournal of pain research2019

Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip.

Leslie Tive, Alfonso E Bello, David Radin, Thomas J Schnitzer, Ha Nguyen, Mark T Brown, Christine R West

Erratum issued 9 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Journal of pain research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 9 registered trials, which are not on this map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00733902 phase3completednot on this map

A phase 3 randomized, double-blind, placebo-controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the knee

TypeinterventionalSponsorPfizerRan2008 to 2010Enrolled697ConditionsArthritis, OsteoarthritisArmstanezumab, Placebo
NCT00744471 phase3completednot on this map

A phase 3 randomized, double-blind, placebo-controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the hip.

TypeinterventionalSponsorPfizerRan2008 to 2010Enrolled627ConditionsArthritis, Osteoarthritis, Osteoarthritis, HipArmstanezumab, Placebo
NCT00809354 phase3terminatednot on this map

A phase 3, multi-center, randomized, double-blind, controlled study of the long-term analgesic efficacy and safety of tanezumab alone or in combination with non-steroidal anti-inflammatory drugs (nsaids) versus nsaids alone in patients with osteoarthritis of the knee or hip

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled2,720ConditionsOsteoarthritis, ArthritisArmsNSAID, tanezumab
NCT00830063 phase3completednot on this map

A phase 3 randomized, double blind placebo and naproxen controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the knee

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled832ConditionsArthritis, OsteoarthritisArmstanezumab 10 mg, tanezumab 5 mg, naproxen, placebo
NCT00863304 phase3completednot on this map

A phase 3 randomized, double blind placebo and naproxen controlled multicenter study of the analgesic efficacy and safety of tanezumab in patients with osteoarthritis of the hip or knee

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled849ConditionsOsteoarthritisArmstanezumab 10 mg, tanezumab 5 mg, naproxen, placebo
NCT00863772 phase3terminatednot on this map

A phase 3 randomized, double-blind, placebo-controlled multicenter study of tanezumab on peripheral nerve function in patients with osteoarthritis.

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled220ConditionsOsteoarthritisArmstanezumab, Placebo
NCT00864097 phase3terminatednot on this map

A phase 3, randomized, double blind, controlled, multi center study of the analgesic efficacy and safety of tanezumab added on to diclofenac sr in patients with osteoarthritis of the knee or hip

TypeinterventionalSponsorPfizerRan2009 to 2010Enrolled607ConditionsOsteoarthritisArmstanezumab, diclofenac, IV placebo
NCT00985621 phase3terminatednot on this map

A phase 3 randomized, double-blind, placebo and oxycodone controlled multi-center study of the efficacy and safety of tanezumab in patients with osteoarthritis of the knee or hip

TypeinterventionalSponsorPfizerRan2009 to 2011Enrolled614ConditionsOsteoarthritisArmstanezumab 10 mg, tanezumab 5 mg, oxycodone, placebo
NCT01089725 phase3terminatednot on this map

A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the analgesic efficacy and safety of subcutaneous administration of tanezumab in patients with osteoarthritis of the knee.

TypeinterventionalSponsorPfizerRan2010 to 2011Enrolled385ConditionsOsteoarthritis, Arthritis, PainArmsPlacebo IV, Placebo SC, Tanezumab SC, Tanezumab IV
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Osteoarthritis Pain.International journal of molecular sciences · 2022
    Review
  17. Article
  18. Review
  19. Nerve Growth Factor (NGF) Inhibitors and Related Agents for Chronic Musculoskeletal Pain: A Comprehensive Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021
    Review
  20. Monoclonal Antibodies for Chronic Pain Treatment: Present and Future.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Leslie TivePfizer Inc, New York, NY, USA, leslie.tive@pfizer.com.
Alfonso E BelloIllinois Bone and Joint Institute, Glenview, IL, USA.
David RadinStamford Therapeutics Consortium, Stamford, CT, USA.
Thomas J SchnitzerDepartment of Physical Medicine and Rehabilitation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Ha NguyenPfizer Inc, New York, NY, USA, leslie.tive@pfizer.com.
Mark T BrownPfizer Inc, Groton, CT, USA.
Christine R WestPfizer Inc, Groton, CT, USA.
Pfizer (United States) · USIllinois Bone and Joint Institute · USNorthwestern University · USStamford Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA pooled analysis was conducted to evaluate tanezumab efficacy and safety in patients with osteoarthritis (OA), including subgroup analyses of at-risk patients with diabetes, severe OA symptoms, and those aged ≥65 years. PATIENTS AND

methodsData from phase III placebo-controlled clinical trials of patients with moderate-to-severe OA of the knee or hip were pooled to evaluate tanezumab efficacy (four trials) and safety (nine trials). Patients received intravenous tanezumab, tanezumab plus an oral NSAID (naproxen, celecoxib, or diclofenac), active comparator (naproxen, celecoxib, diclofenac, or oxycodone), or placebo. Efficacy assessments included change from baseline to week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and physical function scores, Patient's Global Assessment (PGA) of OA, and percentage of patients with ≥30%, ≥50%, ≥70%, and ≥90% improvement in WOMAC pain. Safety assessments included adverse event (AE) documentation and physical and neurologic examinations.

resultsTanezumab significantly improved all efficacy end points in the overall population. Efficacy in at-risk patient subgroups was similar to the overall population. Incidence of AEs was highest in the tanezumab plus NSAID group and lowest in the placebo group. Incidence of AEs in the tanezumab monotherapy and active comparator groups was similar. Overall incidence of AEs was similar across subgroups. AEs of abnormal peripheral sensation were more frequently reported in tanezumab-treated patients compared with placebo or active comparator. Patients receiving active comparator had a slightly higher incidence of AEs suggestive of postganglionic sympathetic dysfunction.

conclusionTanezumab consistently provided significant improvement of pain, physical function, and PGA in individuals with OA, including patients with diabetes, severe OA symptoms, or aged ≥65 years. No increased safety risk was observed in at-risk patient subgroups.

trial registrationNCT00733902, NCT00744471, NCT00830063, NCT00863304, NCT00809354, NCT00864097, NCT00863772, NCT01089725, NCT00985621.

Indexed as

efficacynerve growth factorosteoarthritissafetytanezumab

Identifiers

PMID30936738
PMCPMC6430070
OpenAlexW2922054715

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 3 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.