Evidence map›Paper›PMID 27269295›Full record

Trial reportAnnals of the rheumatic diseases2017

Canakinumab treatment for patients with active recurrent or chronic TNF receptor-associated periodic syndrome (TRAPS): an open-label, phase II study.

Marco Gattorno, Laura Obici, Marco Cattalini, Vincent Tormey, Ken Abrams, Nicole Davis, Antonio Speziale, Suraj G Bhansali, Alberto Martini, Helen J Lachmann

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of the rheumatic diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01242813 (An Open-label, Multicenter, Efficacy and Safety Study of 4-month Canakinumab Treatment With 6-month Follow-up in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome), which is not on this map. Cited by 45 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 3 pooled it
9.1field-weighted citation impact, top 2% 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.

NCT01242813 phase2completednot on this map

An Open-label, Multicenter, Efficacy and Safety Study of 4-month Canakinumab Treatment With 6-month Follow-up in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).

TypeinterventionalSponsorNovartis PharmaceuticalsRan2010 to 2014Enrolled20ConditionsTNF-receptor Associated Periodic Syndromes (TRAPS)ArmsACZ885
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 3 syntheses or guidelines pooled it, 104 citations in OpenAlex.

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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

10 authors at 8 institutions in 6 countries.

Marco GattornoUO Pediatria 2, Reumatologia, Eurofever project, G Gaslini Institute, Genoa, Italy.
Laura ObiciAmyloidosis Research and Treatment Centre, Biotechnology Research Laboratories, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Marco CattaliniPediatric Clinic, University of Brescia and Spedali Civili, Brescia, Italy.
Vincent TormeyGalway University Hospitals, Galway, Ireland.
Ken AbramsNovartis Pharmaceutical Corporation, East Hanover, New Jersey, USA.
Nicole DavisNovartis Pharmaceutical Corporation, East Hanover, New Jersey, USA.
Antonio SpezialeNovartis Pharma AG, Basel, Switzerland.
Suraj G BhansaliNovartis Pharmaceutical Corporation, East Hanover, New Jersey, USA.
Alberto MartiniUO Pediatria 2, Reumatologia, Eurofever project, G Gaslini Institute, Genoa, Italy.
Helen J LachmannDivision of Medicine, National Amyloidosis Center, University College London Medical School, London, UK.
Novartis (Switzerland) · CHAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Giannina Gaslini · ITPharmac · NZUniversity College London · GBUniversity Hospital Galway · IEUniversity of Genoa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of canakinumab, a high-affinity human monoclonal anti-interleukin-1β antibody, in inducing complete or almost complete responses in patients with active tumour necrosis factor receptor-associated periodic syndrome (TRAPS).

methodsTwenty patients (aged 7-78 years) with active recurrent or chronic TRAPS were treated with canakinumab 150 mg every 4 weeks for 4 months (2 mg/kg for those ≤40 kg) in this open-label, proof-of-concept, phase II study. Canakinumab was then withdrawn for up to 5 months, with reintroduction on relapse, and 4 weekly administration (subsequently increased to every 8 weeks) for 24 months. The primary efficacy variable was the proportion of patients achieving complete or almost complete response at day 15, defined as clinical remission (Physician's Global Assessment score ≤1) and full or partial serological remission.

resultsNineteen patients (19/20, 95%; 95% CI 75.1% to 99.9%) achieved the primary efficacy variable. Responses to canakinumab occurred rapidly; median time to clinical remission 4 days (95% CI 3 to 8 days). All patients relapsed after canakinumab was withdrawn; median time to relapse 91.5 days (95% CI 65 to 117 days). On reintroduction of canakinumab, clinical and serological responses were similar to those seen during the first phase, and were sustained throughout treatment. Canakinumab was well tolerated and clinical responses were accompanied by rapid and sustained improvement in health-related quality of life. Weight normalised pharmacokinetics of canakinumab, although limited, appeared to be consistent with historical canakinumab data.

conclusionsCanakinumab induces rapid disease control in patients with active TRAPS, and clinical benefits are sustained during long-term treatment. TRIAL REGISTRATION NUMBER: NCT01242813; Results.

Indexed as

AdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedChildChronic DiseaseDrug Administration ScheduleFamilial Mediterranean FeverFemaleHumansImmunologic FactorsMaleMiddle AgedQuality of LifeReceptors, Tumor Necrosis FactorAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedcanakinumabImmunologic FactorsReceptors, Tumor Necrosis FactorCytokinesFever SyndromesTNF-alphaTreatment

Identifiers

PMID27269295
PMCPMC5264215
OpenAlexW2414265798

What OpenQuestion holds

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LicenceCC BY-NC
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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.