Evidence map›Paper›PMID 32234715›Full record

Trial reportAnnals of the rheumatic diseases2020

Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period.

Francis Berenbaum, Francisco J Blanco, Ali Guermazi, Kenji Miki, Takaharu Yamabe, Lars Viktrup, Rod Junor, William Carey, Mark T Brown, Christine R West and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02709486 (A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE), which is not on this map. Cited by 86 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 8 pooled it
21.6field-weighted citation impact, top 1% 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.

NCT02709486 phase3completednot on this map

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

TypeinterventionalSponsorPfizerRan2016 to 2018Enrolled849ConditionsOsteoarthritis, Hip, Osteoarthritis, KneeArmsTanezumab, Placebo
3 · Its place in the literature

Who cites it

86 citing papers in PubMed, 8 syntheses or guidelines pooled it, 163 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

26 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 4 countries.

Francis BerenbaumDepartment of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint Antoine, Paris, France francis.berenbaum@aphp.fr.ORCID 0000-0001-8252-7815
Francisco J BlancoServicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, La Coruña, Spain.ORCID 0000-0001-9821-7635
Ali GuermaziDepartment of Radiology, Boston University School of Medicine, Boston, Massachusetts, USA.
Kenji MikiFaculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.
Takaharu YamabePfizer Inc, Groton, Connecticut, USA.
Lars ViktrupEli Lilly and Company, Indianapolis, Indiana, USA.
Rod JunorPfizer Ltd, Tadworth, UK.
William CareyPfizer Ltd, Tadworth, UK.
Mark T BrownPfizer Inc, Groton, Connecticut, USA.
Christine R WestPfizer Inc, Groton, Connecticut, USA.
Kenneth M VerburgPfizer Inc, Groton, Connecticut, USA.
Pfizer (United States) · USPfizer (United Kingdom) · GBBoston University · USComplexo Hospitalario Universitario A Coruña · ESEli Lilly (United States) · USInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up.

methodsThis double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient's Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study.

resultsFrom March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE -0.62±0.18, p=0.0006), WOMAC Physical Function (-0.71±0.17, p<0.0001) and PGA-OA (-0.19±0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%-7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo.

conclusionTanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups. TRIAL REGISTRATION NUMBER: NCT02709486.

Indexed as

AdultAgedAged, 80 and overAnalgesicsAntibodies, Monoclonal, HumanizedArthroplasty, Replacement, HipArthroplasty, Replacement, KneeDisease ProgressionDouble-Blind MethodFemaleFollow-Up StudiesHumansHypesthesiaInjections, SubcutaneousMaleMiddle AgedAnalgesicsAntibodies, Monoclonal, Humanizedtanezumabanalgesicsknee osteoarthritisosteoarthritis

Identifiers

PMID32234715
PMCPMC7286052
OpenAlexW3014194256

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.