Evidence map›Paper›PMID 29066464›Full record

Trial reportAnnals of the rheumatic diseases2018

Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate).

Dinesh Khanna, Christopher P Denton, Celia J F Lin, Jacob M van Laar, Tracy M Frech, Marina E Anderson, Murray Baron, Lorinda Chung, Gerhard Fierlbeck, Santhanam Lakshminarayanan and 10 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 112 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
112citing papers in PubMed, 8 pooled it
24.3field-weighted citation impact, top 1% 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.

NCT01532869 phase3completednot on this map

A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

TypeinterventionalSponsorHoffmann-La RocheRan2012 to 2015Enrolled87ConditionsSclerosis, SystemicArmsPlacebo, tocilizumab [RoActemra/Actemra]
NCT04986605 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

The Effectiveness of ECP in Diffuse Cutaneous Systemic Sclerosis

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2025 to 2027Enrolled15ConditionsDiffuse Cutaneous Systemic SclerosisArmsExtracorporeal Photopheresis (ECP), UVADEX
NCT05149768 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2024 to 2026Enrolled11ConditionsDiffuse Cutaneous Systemic SclerosisArmsBrentuximab vedotin
3 · Its place in the literature

Who cites it

112 citing papers in PubMed, 8 syntheses or guidelines pooled it, 252 citations in OpenAlex.

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52 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 6 countries.

Dinesh KhannaUniversity of Michigan Scleroderma Program, Ann Arbor, Michigan, USA.
Christopher P DentonUniversity College London Medical School, London, UK.
Celia J F LinGenentech, South San Francisco, California, USA.
Jacob M van LaarUniversity Medical Center Utrecht, Utrecht, Netherlands.
Tracy M FrechUniversity of Utah, Veterans Affairs Medical Center, Salt Lake City, Utah, USA.
Marina E AndersonUniversity of Liverpool and Aintree University Hospital, Liverpool, UK.
Murray BaronJewish General Hospital, Montreal, Canada.
Lorinda ChungStanford University School of Medicine and Palo Alto VA Health Care System, Palo Alto, California, USA.
Gerhard FierlbeckUniversity of Tübingen, Tübingen, Germany.
Santhanam LakshminarayananUniversity of Connecticut Health Center, Farmington, Connecticut, USA.
Yannick AllanoreParis Descartes University, Paris, France.
Janet E PopeSchulich School of Medicine and Dentistry, University of Western Ontario, St Joseph's Health Care, London, Canada.
Gabriela RiemekastenUniversity of Lübek and Charité University Hospital, Berlin, Germany.
Virginia SteenGeorgetown University, Washington, DC, USA.
Ulf Müller-LadnerJustus-Liebig University Giessen, Kerckhoff Clinic, Bad Nauheim, Germany.
Helen SpotswoodRoche Products Ltd, Welwyn Garden City, UK.
Laura BurkeRoche Products Ltd, Welwyn Garden City, UK.
Jeffrey SiegelGenentech, South San Francisco, California, USA.
Angelika JahreisGenentech, South San Francisco, California, USA.
Daniel E FurstUniversity of California, Los Angeles, California, USA.
Roche (United Kingdom) · GBCharité - Universitätsmedizin Berlin · DEGeorgetown University · USJewish General Hospital · CAKerckhoff Klinik · DEScleroderma Foundation · USUConn Health · USUniversité Paris Cité · FRUniversity College London · GBUniversity Medical Center Utrecht · NLUniversity of California, Los Angeles · USUniversity of Liverpool · GBUniversity of Tübingen · DEUniversity of Utah · USVA Palo Alto Health Care System · USWestern University · CA

Funding

Systemic sclerosis (SSc) vasculopathy: Improved clinical monitoring and treatmentI01CX001183 · VA · VA SALT LAKE CITY HEALTHCARE SYSTEM · PI FRECH, TRACY MINAN · 2016 to 2020
–
CSRD VA I01 CX001183
6 · The paper itself

Abstract

objectivesAssess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study.

methodsPatients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162 mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96.

resultsOverall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96. Observed mean (SD (95% CI)) change from baseline in mRSS was -3.1 (6.3 (-5.4 to -0.9)) for placebo and -5.6 (9.1 (-8.9 to-2.4)) for tocilizumab at week 48 and -9.4 (5.6 (-8.9 to -2.4)) for placebo-tocilizumab and -9.1 (8.7 (-12.5 to -5.6)) for continuous-tocilizumab at week 96. Of patients who completed week 96, any decline in %pFVC was observed for 10/24 (42% (95% CI 22% to 63%)) placebo-tocilizumab and 12/26 (46% (95% CI 27% to 67%)) continuous-tocilizumab patients in the open-label period; no patients had >10% absolute decline in %pFVC. Serious infection rates/100 patient-years (95% CI) were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind period by week 48 and 19.6 (7.2 to 42.7) with placebo-tocilizumab and 0.0 (0.0 to 12.2) with continuous-tocilizumab during the open-label period.

conclusionsSkin score improvement and FVC stabilisation in the double-blind period were observed in placebo-treated patients who transitioned to tocilizumab and were maintained in the open-label period. Safety data indicated increased serious infections in patients with SSc but no new safety signals with tocilizumab. TRIAL REGISTRATION NUMBER: NCT01532869; Results.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsDouble-Blind MethodFemaleHumansInjections, SubcutaneousMaleMiddle AgedScleroderma, SystemicSeverity of Illness IndexSkinTreatment OutcomeVital CapacityAntibodies, Monoclonal, HumanizedAntirheumatic AgentstocilizumabDMARDs (biologic)interleukin-6sclerodermasystemic sclerosis (SSc)tocilizumabtreatment

Identifiers

PMID29066464
PMCPMC5867414
OpenAlexW2766145635

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.