Evidence map›Paper›PMID 32449924›Full record

SynthesisRheumatology (Oxford, England)2020

Safety of ixekizumab in adult patients with plaque psoriasis, psoriatic arthritis and axial spondyloarthritis: data from 21 clinical trials.

Mark C Genovese, Eduardo Mysler, Tetsuya Tomita, Kim A Papp, Carlo Salvarani, Sergio Schwartzman, Gaia Gallo, Himanshu Patel, Jeffrey R Lisse, Andris Kronbergs and 5 more

Erratum issuedOpen access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 7% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 71 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 5 countries.

Mark C GenoveseDepartment of Medicine, Stanford University Medical Center, Palo Alto, CA, USA.
Eduardo MyslerOrganización Medica de Investigación, Buenos Aires, Argentina.
Tetsuya TomitaDepartment of Orthopedic Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Kim A PappClinical Research and Probity Medical Research Inc., Waterloo, and the University of Toronto, Toronto, Canada.
Carlo SalvaraniAzienda USL-IRCCS di Reggio Emilia, Università di Modena e Reggio Emilia, Modena, Emilia-Romagna, Italy.
Sergio SchwartzmanDepartment of Medicine, The Hospital for Special Surgery, New York, NY.
Gaia GalloEli Lilly and Company, Indianapolis, IN, USA.
Himanshu PatelEli Lilly and Company, Indianapolis, IN, USA.
Jeffrey R LisseEli Lilly and Company, Indianapolis, IN, USA.
Andris KronbergsEli Lilly and Company, Indianapolis, IN, USA.
Soyi Liu LeageEli Lilly and Company, Indianapolis, IN, USA.
David H AdamsEli Lilly and Company, Indianapolis, IN, USA.
Wen XuEli Lilly and Company, Indianapolis, IN, USA.
Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust and LIRMM, University of Leeds, Leeds, UK.
Mark G LebwohlDepartment of Dermatology, Mount Sinai Hospital, New York, NY, USA.
Eli Lilly (United States) · USHospital for Special Surgery · USIstituti di Ricovero e Cura a Carattere Scientifico · ITLeeds Teaching Hospitals NHS Trust · GBMount Sinai Hospital · USOsaka University · JPProbity Medical Research · CAStanford Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this integrated analysis is to evaluate the long-term safety and tolerability of ixekizumab in adults with psoriasis, PsA and axial SpA.

methodsIntegrated safety data from 21 clinical trials are presented by indication in patients who received at least one dose of ixekizumab. Adverse events (AEs) and treatment-emergent adverse events (TEAEs) adjusted incidence rates (IRs) per 100 patient-years (PY) up to 5 years' exposure are reported.

resultsA total of 8228 patients with an ixekizumab exposure of 20 895.9 PY were included in this analysis. The most common TEAEs were nasopharyngitis, upper respiratory tract infection and injection-site reactions. Across populations, IRs were low for AEs leading to discontinuation (IRs ≤5.1 per 100 PY), serious AEs (IRs ≤6.0 per 100 PY) and death (IRs ≤0.3 per 100 PY). The most reported TEAEs of special interest were infections (IRs ≤35.8 per 100 PY). Patients rarely reported malignancies (IR ≤0.8), IBD including ulcerative colitis and Crohn's disease (IR ≤0.8) and major adverse cardiovascular events (IR ≤0.5). TEAEs were most commonly reported the first 2 years of exposure with ixekizumab and IR decreased over the years (infections, injection-site reactions and depression) or remained constant over the entire treatment period (serious infections, major adverse cardiovascular events, malignancies and IBD).

conclusionThis long-term analysis on the safety of ixekizumab was consistent with previously published reports and did not show any new safety signals. The safety profile and tolerability reported in this integrated analysis remained consistent with the known safety profile for ixekizumab.

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticDermatologic AgentsDrug HypersensitivityHumansInfectionsInjection Site ReactionRandomized Controlled Trials as TopicSpondylarthritisAntibodies, Monoclonal, HumanizedDermatologic Agentsixekizumabaxial spondyloarthritisIL-17ixekizumabpsoriasispsoriatic arthritissafety

Identifiers

PMID32449924
PMCPMC7733711
OpenAlexW3032589454

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.