Evidence map›Paper›PMID 32453139›Full record

Trial reportPain2020

Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety.

John D Markman, Robert B Bolash, Timothy E McAlindon, Alan J Kivitz, Manuel Pombo-Suarez, Seiji Ohtori, Frank W Roemer, David J Li, Lars Viktrup, Candace Bramson and 2 more

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

Trial report in Pain, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02528253 (A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN), which is not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
6.0field-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.

NCT02528253 phase3completednot on this map

A phase 3, randomized, double blind, placebo and active-controlled, multicenter, parallel-group study of the analgesic efficacy and safety of tanezumab in adult subjects with chronic low back pain

TypeinterventionalSponsorPfizerRan2015 to 2018Enrolled1,832ConditionsLow Back PainArmsPlacebo to Week 16, tanezumab 5mg SC, Placebo to Week 16, tanezumab 10 mg SC, Tanezumab 5 mg SC, Tanezumab 10 mg SC
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2022
    Guideline
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Stress-response exhaustion in intervertebral disc degeneration.Frontiers in cell and developmental biology · 2026
    Review
  9. Article
  10. Review
  11. Mechanism-based nonopioid analgesic targets.The Journal of clinical investigation · 2025
    Review
  12. Pain Medication in Chronic Low Back Pain.Life (Basel, Switzerland) · 2025
    Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 4 countries.

John D MarkmanTranslational Pain Research Program, Department of Neurosurgery, University of Rochester Medical Center, Rochester, NY, United States.
Robert B BolashDepartments of Pain Management and Evidence Based Pain Research, Cleveland Clinic, Cleveland, OH, United States.
Timothy E McAlindonDivision of Rheumatology, Allergy & Immunology, Tufts Medical Center, Boston, OH, United States.
Alan J KivitzAltoona Center for Clinical Research, Duncansville, PA, United States.
Manuel Pombo-SuarezRheumatology Service, Rheumatology Service, Hospital Clinico Universitario Santiago, Santiago de Compostela, Spain.
Seiji OhtoriDepartment of Orthopaedic Surgery, Chiba University, Chiba, Japan.
Frank W RoemerDepartment of Radiology, Boston University, Boston, MA, United States.
David J LiPfizer Inc, Collegeville, PA, United States. Dr. Li is now with the Eisai Inc, Woodcliff Lake, NJ, United States).
Lars ViktrupEli Lilly & Company, Indianapolis, IN, United States.
Candace BramsonPfizer Inc, Groton, CT, United States.
Christine R WestPfizer Inc, Groton, CT, United States.
Kenneth M VerburgPfizer Inc, Groton, CT, United States.
Pfizer (United States) · USAltoona Center for Clinical Research · USChiba University · JPCleveland Clinic · USComplejo Hospitalario Universitario de Santiago · ESEli Lilly (United States) · USFriedrich-Alexander-Universität Erlangen-Nürnberg · DETufts Medical Center · USUniversity of Rochester Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractThis randomized, double-blind, phase 3 study (56-week treatment; 24-week follow-up) assessed tanezumab in patients with chronic low back pain and history of inadequate response to standard-of-care analgesics (NCT02528253). Patients received placebo, subcutaneous tanezumab (5 or 10 mg every 8 weeks), or oral tramadol prolonged-release (100-300 mg/day). Primary endpoint was change in low back pain intensity (LBPI) at week 16 for tanezumab vs placebo. Key secondary endpoints were proportion of patients with ≥50% decrease in LBPI at week 16, change in Roland Morris Disability Questionnaire at week 16, and change in LBPI at week 2 for tanezumab vs placebo. Adverse events and joint safety were assessed through weeks 56 and 80, respectively. Tanezumab 10 mg met the primary endpoint by significantly improving LBPI at week 16 vs placebo; least squares (LS) mean (95% CI) difference = -0.40 (-0.76 to -0.04; P = 0.0281). Tanezumab 10 mg significantly improved all key secondary endpoints. Tanezumab 5 mg did not meet the primary endpoint (LS mean [95% CI] treatment difference vs placebo = -0.30 [-0.66 to 0.07; P = 0.1117]), preventing formal testing of key secondary endpoints for this dose. The proportion of patients with ≥50% improvement in LBPI at week 16 was 37.4% in the placebo group, 43.3% in the tanezumab 5 mg group (Odds ratio [95% CI] vs placebo = 1.28 [0.97 to 1.70; P = 0.0846]), and 46.3% in the tanezumab 10 mg group (Odds ratio [95% CI] vs placebo = 1.45 [1.09 to 1.91; P = 0.0101]). Prespecified joint safety events were more frequent with tanezumab 10 mg (2.6%) than tanezumab 5 mg (1.0%), tramadol (0.2%), or placebo (0%). Seven patients, all in the tanezumab 10 mg group (1.4%), underwent total joint replacement. In conclusion, tanezumab 10 mg significantly improved pain and function vs placebo in patients with difficult-to-treat chronic low back pain. Tanezumab was associated with a low rate of joint safety events, some requiring joint replacement.

Indexed as

Low Back PainAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPain MeasurementTreatment OutcomeAntibodies, Monoclonal, Humanizedtanezumab

Identifiers

PMID32453139
PMCPMC7431140
OpenAlexW3027729271

What OpenQuestion holds

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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.