Evidence map›Paper›PMID 29770930›Full record

Observational studyClinical rheumatology2018

Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real-life clinical practice: a nationwide multicenter retrospective observational study.

Jurgen Sota, Antonio Vitale, Antonella Insalaco, Paolo Sfriso, Giuseppe Lopalco, Giacomo Emmi, Marco Cattalini, Raffaele Manna, Rolando Cimaz, Roberta Priori and 43 more

Open access · greenAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical rheumatology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 3 pooled it
8.5field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 3 syntheses or guidelines pooled it, 80 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

53 authors at 15 institutions in 1 country.

Jurgen SotaResearch Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Policlinico "Le Scotte", viale Bracci 1, 53100, Siena, Italy.
Antonio VitaleResearch Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Policlinico "Le Scotte", viale Bracci 1, 53100, Siena, Italy.
Antonella InsalacoDivision of Rheumatology, Department of Pediatric Medicine, IRCCS, Bambino Gesù Children's Hospital, Rome, Italy.
Paolo SfrisoRheumatology Unit, Department of Medicine, University of Padua, Padua, Italy.
Giuseppe LopalcoInterdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy.
Giacomo EmmiDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Marco CattaliniPediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
Raffaele MannaInstitute of Internal Medicine, Periodic Fever Research Center, Fondazione Policlinico A. Gemelli, Università Cattolica Sacro Cuore, Rome, Italy.
Rolando CimazPediatric Rheumatology Unit, AOU Meyer, Florence, Italy.
Roberta PrioriDepartment of Internal Medicine and Medical Specialties, Rheumatology Unit, Sapienza University of Rome, Rome, Italy.
Rosaria TalaricoRheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Ginevra de MarchiDepartment of Medical and Biological Sciences, Rheumatology Clinic, University of Udine, Udine, Italy.
Micol FrassiRheumatology and Clinical Immunology, Spedali Civili, and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Romina GallizziDepartment of Pediatrics, Azienda G. Martino, University of Messina, Messina, Italy.
Alessandra SorianoRheumatology Unit, Department of Internal Medicine, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
Maria AlessioUniversity Federico II, Naples, Italy.
Daniele CammelliExperimental and Clinical Medicine Department, University of Florence, Florence, Italy.
Maria Cristina MaggioUniversitary Department "Pro.S.A.M.I.", University of Palermo, Palermo, Italy.
Stefano GentileschiResearch Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Policlinico "Le Scotte", viale Bracci 1, 53100, Siena, Italy.
Renzo MarcolongoClinical Immunology, Department of Medicine, University of Padua, Padua, Italy.
Francesco La TorrePediatric Rheumatology Section, Pediatric Oncoematology Unit, Vito Fazzi Hospital, Lecce, Italy.
Claudia FabianiDepartment of Ophthalmology, Humanitas Research Hospital, Rozzano, Milan, Italy.
Serena ColafrancescoDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Francesca RicciPediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
Paola GalozziRheumatology Unit, Department of Medicine, University of Padua, Padua, Italy.
Ombretta ViapianaRheumatology Section, Department of Medicine, University of Verona, Verona, Italy.
Elena VerrecchiaInstitute of Internal Medicine, Periodic Fever Research Center, Fondazione Policlinico A. Gemelli, Università Cattolica Sacro Cuore, Rome, Italy.
Manuela PardeoDivision of Rheumatology, Department of Pediatric Medicine, IRCCS, Bambino Gesù Children's Hospital, Rome, Italy.
Lucia CerritoInstitute of Internal Medicine, Periodic Fever Research Center, Fondazione Policlinico A. Gemelli, Università Cattolica Sacro Cuore, Rome, Italy.
Elena CavallaroDepartment of Medical and Biological Sciences, Rheumatology Clinic, University of Udine, Udine, Italy.
Alma Nunzia OlivieriDipartimento della Donna, del Bambino e di Chirurgia Generale e Specialistica, Seconda Università degli Studi of Naples, Naples, Italy.
Giuseppe PaolazziDepartment of Rheumatology, Santa Chiara Hospital, Trento, Italy.
Gianfranco VitielloExperimental and Clinical Medicine Department, University of Florence, Florence, Italy.
Armin MaierStruttura Semplice di Reumatologia, Ospedale di Bolzano, Bolzano, Italy.
Elena SilvestriDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Chiara StagnaroRheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Guido ValesiniDepartment of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Marta MoscaRheumatology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Salvatore de VitaDepartment of Medical and Biological Sciences, Rheumatology Clinic, University of Udine, Udine, Italy.
Angela TincaniRheumatology and Clinical Immunology, Spedali Civili, and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Giovanni LapadulaInterdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy.
Bruno FredianiResearch Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Policlinico "Le Scotte", viale Bracci 1, 53100, Siena, Italy.
Fabrizio De BenedettiDivision of Rheumatology, Department of Pediatric Medicine, IRCCS, Bambino Gesù Children's Hospital, Rome, Italy.
Florenzo IannoneInterdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy.
Leonardo PunziRheumatology Unit, Department of Medicine, University of Padua, Padua, Italy.
Carlo SalvaraniRheumatology Unit, Department of Internal Medicine, Azienda Ospedaliera ASMN, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.
Mauro GaleazziResearch Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Policlinico "Le Scotte", viale Bracci 1, 53100, Siena, Italy.
Rossella AngottiDivision of Pediatric Surgery, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy.
Mario MessinaDivision of Pediatric Surgery, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy.
Gian Marco TosiOphthalmology Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
Donato RiganteInstitute of Pediatrics, Periodic Fever Research Center, Fondazione Policlinico A. Gemelli, Università Cattolica Sacro Cuore, Rome, Italy.
Luca CantariniResearch Center of Systemic Autoinflammatory Diseases, Behçet's Disease Clinic and Rheumatology-Ophthalmology Collaborative Uveitis Center, Department of Medical Sciences, Surgery and Neurosciences, Rheumatology Unit, University of Siena, Policlinico "Le Scotte", viale Bracci 1, 53100, Siena, Italy. cantariniluca@hotmail.com.ORCID http://orcid.org/0000-0002-7352-1275
“Working Group” of Systemic Autoinflammatory Diseases of SIR (Italian Society of Rheumatology)
University of Siena · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Padua · ITUniversity of Pisa · ITUniversity of Udine · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITFederico II University Hospital · ITOspedale di Bolzano · ITOspedale Santa Chiara · ITUniversity of Florence · ITUniversity of Messina · ITBambino Gesù Children's Hospital · ITMeyer Children's Hospital · ITUniversity of Bari Aldo Moro · ITUniversity of Verona · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24.39 ± 27.04 months, 89 adverse events (AE) were recorded; 13 (14.61%) were classified as serious AE (sAE). The overall estimated rate of AE and sAE was 8.4 per 100 patients/year. Safety concerns were more frequent among patients aged ≥ 65 years compared with patients < 16 years (p = 0.002). No differences were detected in the frequency of safety concerns between monotherapy and combination therapy with immunosuppressants (p = 0.055), but a significant difference was observed when injection site reactions were excluded from AE (p = 0.01). No differences were identified in relation to gender (p = 0.462), different lines of biologic therapy (p = 0.775), and different dosages (p = 0.70 ANA; p = 0.39 CAN). The overall drug retention rate was significantly different according to the occurrence of safety concerns (p value < 0.0001); distinguishing between ANA and CAN, significance was maintained only for ANA (p < 0.0001 ANA; p > 0.05 CAN). Treatment duration was the only variable associated with onset of AE (OR = 0.399 [C.I. 0.250-0.638], p = 0.0001). ANA and CAN have shown an excellent safety profile; the risk for AE and sAE tends to decrease over time from the start of IL-1 inhibition.

Indexed as

AdolescentAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAutoimmune DiseasesChildFemaleHumansInterleukin 1 Receptor Antagonist ProteinLogistic ModelsMaleMiddle AgedRetrospective StudiesTreatment OutcomeYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedcanakinumabInterleukin 1 Receptor Antagonist ProteinAnakinraAutoinflammatory disordersCanakinumabInterleukin-1Safety profile

Identifiers

PMID29770930
OpenAlexW2804258587

What OpenQuestion holds

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Registered trials

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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.