Evidence map›Paper›PMID 40001000›Full record

Trial reportBMC musculoskeletal disorders2025

Efficacy and safety of fasinumab in an NSAID-controlled study in patients with pain due to osteoarthritis of the knee or hip.

Stephen J DiMartino, Haitao Gao, Simon Eng, Guillermo Valenzuela, Thomas Fuerst, Chetachi Emeremni, Tina Ho, Hazem E Hassan, Kenneth C Turner, John D Davis and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03304379 (Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT03304379 phase3completednot on this map

Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2017 to 2020Enrolled1,650ConditionsOsteoarthritis, Knee, Osteoarthritis, HipArmsFasinumab, Diclofenac, Celecoxib, Matching placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  3. Review
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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

20 authors.

Stephen J DiMartinoRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA. stephen.dimartino@regeneron.com.
Haitao GaoRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Simon EngRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Guillermo ValenzuelaIntegral Rheumatology & Immunology Specialists, Plantation, FL, USA.
Thomas FuerstClario, San Mateo, CA, USA.
Chetachi EmeremniRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Tina HoRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Hazem E HassanRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Kenneth C TurnerRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
John D DavisRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Souhil ZaimClario, San Mateo, CA, USA.
Jesse ChaoRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Yamini PatelRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Lillian BrenerRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Ngan TrinhRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Garen ManvelianRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Michael FetellTeva Pharmaceuticals, Westchester, PA, USA.
Ned BraunsteinRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Gregory P GebaRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.
Paula DakinRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY, 10591, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveOsteoarthritis (OA) causes significant musculoskeletal pain. This study assessed the efficacy and safety of fasinumab, an investigational nerve growth factor inhibitor, in patients with moderate-to-severe OA pain of the knee/hip.

methodsIn this Phase 3, randomized, double-blind, placebo- and non-steroidal anti-inflammatory drug (NSAID)-controlled study, patients with OA (Kellgren-Lawrence grade ≥ 2; Western Ontario and McMaster Universities Arthritis Index [WOMAC] pain score ≥ 4) received (2:1:1:1) fasinumab 1 mg every 4 weeks, diclofenac 75 mg twice daily, celecoxib 200 mg daily, or placebo for 24 weeks. Co‑primary endpoints were change in WOMAC pain and physical function scores to Week 24 versus placebo. For safety, joints were imaged in all patients at pre‑specified times, regardless of symptoms.

resultsOf 4531 patients screened, 1650 were randomized. At Week 24, greater improvements were observed for fasinumab versus placebo; least-squares mean difference: -0.63 (p = 0.0003) for WOMAC pain and -0.64 (p = 0.0003) for physical function. Improvements were numerically greater for fasinumab versus NSAIDs for physical function (-0.64 versus -0.31; nominal p < 0.05) and pain (-0.63 versus - 0.39; p = NS). Adjudicated arthropathies occurred in 1.6% of placebo-treated, 1.5% of NSAID-treated, and 5.6% of fasinumab-treated patients; joint replacements occurred in 3.6% of placebo-treated, 4.8% of NSAID-treated, and 3.4% of fasinumab-treated patients.

conclusionFasinumab significantly improved WOMAC pain and physical function scores versus placebo in < 24 weeks in difficult-to-treat patients with pain due to OA of the knee/hip. Adjudicated arthropathies were more frequent with fasinumab; there were no differences in the proportions of patients with joint replacements.

trial registrationClinicaltrials.gov NCT03304379. Date of first registration: October 2, 2017.

Indexed as

Antibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-SteroidalArthralgiaOsteoarthritis, HipOsteoarthritis, KneeAgedCelecoxibDiclofenacDouble-Blind MethodFemaleHumansMaleMiddle AgedPain MeasurementTreatment OutcomeAntibodies, Monoclonal, HumanizedAnti-Inflammatory Agents, Non-SteroidalCelecoxibDiclofenacFasinumabNGF inhibitorNSAIDOsteoarthritisPain

Identifiers

PMID40001000
PMCPMC11853225

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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.