Evidence map›Paper›PMID 33728717›Full record

Trial reportEuropean journal of pain (London, England)2021

Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained?

Francis Berenbaum, Richard Langford, Serge Perrot, Kenji Miki, Francisco J Blanco, Takaharu Yamabe, Naoki Isogawa, Rod Junor, William Carey, Lars Viktrup and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of pain (London, England), 2021. 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 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 16% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Monoclonal Antibodies for Chronic Pain Treatment: Present and Future.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 5 countries.

Francis BerenbaumDepartment of Rheumatology, Sorbonne Université, INSERM CRSA, AP-HP Hopital Saint Antoine, Paris, France.ORCID 0000-0001-8252-7815
Richard LangfordPain and Anaesthesia Research Centre, St Bartholomew's Hospital, London, UK.
Serge PerrotCochin Hospital, Paris University, INSERM U987, Paris, France.
Kenji MikiFaculty of Health Science, Osaka Yukioka College of Health Science, Hayaishi Hospital, Osaka, Japan.
Francisco J BlancoServicio de Reumatología, INIBC-Complejo Hospitalario Universitario A Coruña, Universidad de A Coruña, CICA-INIBIC, La Coruña, Spain.
Takaharu YamabePfizer Inc, Groton, CT, USA.
Naoki IsogawaPfizer R&D Japan, Tokyo, Japan.
Rod JunorPfizer Ltd, Tadworth, UK.
William CareyPfizer Ltd, Tadworth, UK.
Lars ViktrupEli Lilly and Company, Indianapolis, IN, USA.
Christine R WestPfizer Inc, Groton, CT, USA.
Mark T BrownPfizer Inc, Groton, CT, USA.
Kenneth M VerburgPfizer Inc, Groton, CT, USA.
Pfizer (United States) · USInserm · FREli Lilly (United States) · USInstituto de Investigación Biomédica de A Coruña · ESPfizer (Japan) · JPSt Bartholomew's Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate if early improvements in pain and function with subcutaneous tanezumab are meaningful and sustained over 24 weeks.

methodsPatients with moderate-to-severe osteoarthritis (hip or knee) in Europe and Japan were randomized to placebo, tanezumab 2.5 mg or tanezumab 5 mg (baseline, Week 8 and Week 16). Outcomes included: average daily index joint pain score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscales, rescue medication use, WOMAC responders (within-patient ≥30% reduction in WOMAC Pain or Physical Function), Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responders (within-patient) and Patient-reported Treatment Impact Assessment-Modified questionnaire.

resultsPatients received placebo (n = 282), tanezumab 2.5 mg (n = 283) or tanezumab 5 mg (n = 284). Changes from baseline in average daily index joint pain (within the first week) and WOMAC subscales (Week 2 through Week 24) were greater for each tanezumab group versus placebo (least squares [LS] mean, unadjusted p ≤ .05). Rescue medication use (days/week) was lower for each tanezumab group versus placebo from Week 2 through Week 12 (LS mean, unadjusted p ≤ .05) but not at Week 16 or 24. A higher proportion of each tanezumab group than placebo achieved ≥30% reduction from baseline in WOMAC Pain or Physical Function, or OMERACT-OARSI response (Week 2 through Week 24, unadjusted p ≤ .05), or were satisfied with treatment at Week 24 (unadjusted p ≤ .05).

conclusionsSubcutaneous tanezumab, compared with placebo, reduced pain within the first week, and pain and function were improved throughout 24 weeks. The proportions of responders and patients satisfied were higher with tanezumab than placebo. ClinicalTrials.gov:NCT02709486. SIGNIFICANCE: This exploratory analysis of data from a placebo-controlled, Phase 3 study of patients with moderate-to-severe osteoarthritis of the hip or knee for whom standard analgesics were not effective or could not be taken, found that onset of efficacy of subcutaneous tanezumab was within the first week, and efficacy was maintained through the 24-week treatment period. Tanezumab was effective in those patients with the most radiologically severe osteoarthritis.

Indexed as

Osteoarthritis, HipOsteoarthritis, KneeAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPainPain MeasurementTreatment OutcomeAntibodies, Monoclonal, Humanizedtanezumab

Identifiers

PMID33728717
PMCPMC8360021
OpenAlexW3138064620

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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.