Evidence map›Paper›PMID 27009916›Full record

Trial reportAnnals of the rheumatic diseases2016

Sifalimumab, an anti-interferon-α monoclonal antibody, in moderate to severe systemic lupus erythematosus: a randomised, double-blind, placebo-controlled study.

Munther Khamashta, Joan T Merrill, Victoria P Werth, Richard Furie, Kenneth Kalunian, Gabor G Illei, Jorn Drappa, Liangwei Wang, Warren Greth, CD1067 study investigators

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01283139 (A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus), which is not on this map. Cited by 245 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
245citing papers in PubMed, 11 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.

NCT01283139 phase2completednot on this map

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

TypeinterventionalSponsorMedImmune LLCRan2011 to 2014Enrolled834ConditionsSystemic Lupus ErythematosusArmsSifalimumab 200 mg, Sifalimumab 600 mg, Sifalimumab 1,200 mg, Placebo
3 · Its place in the literature

Who cites it

245 citing papers in PubMed, 11 syntheses or guidelines pooled it.

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  8. Interventions for cutaneous disease in systemic lupus erythematosus.The Cochrane database of systematic reviews · 2021
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185 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Munther KhamashtaGraham Hughes Lupus Research Laboratory, Division of Women's Health, King's College London, The Rayne Institute, St Thomas' Hospital, London, UK.
Joan T MerrillClinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.
Victoria P WerthLupus Research Institute, Philadelphia VA Medical Center, Philadelphia, Pennsylvania, USA University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Richard FurieDivision of Rheumatology, Northwell Health, Great Neck, New York, USA.
Kenneth KalunianDepartment of Rheumatology, UCSD School of Medicine, La Jolla, California, USA.
Gabor G IlleiClinical Development, Respiratory, Inflammation and Autoimmunity, MedImmune, Gaithersburg, Maryland, USA.
Jorn DrappaClinical Development, Respiratory, Inflammation and Autoimmunity, MedImmune, Gaithersburg, Maryland, USA.
Liangwei WangDepartment of Biostatistics, MedImmune, Gaithersburg, Maryland, USA.
Warren GrethClinical Development, Respiratory, Inflammation and Autoimmunity, MedImmune, Gaithersburg, Maryland, USA.
CD1067 study investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe efficacy and safety of sifalimumab were assessed in a phase IIb, randomised, double-blind, placebo-controlled study (NCT01283139) of adults with moderate to severe active systemic lupus erythematosus (SLE).

methods431 patients were randomised and received monthly intravenous sifalimumab (200 mg, 600 mg or 1200 mg) or placebo in addition to standard-of-care medications. Patients were stratified by disease activity, interferon gene-signature test (high vs low based on the expression of four genes) and geographical region. The primary efficacy end point was the percentage of patients achieving an SLE responder index response at week 52.

resultsCompared with placebo, a greater percentage of patients who received sifalimumab (all dosages) met the primary end point (placebo: 45.4%; 200 mg: 58.3%; 600 mg: 56.5%; 1200 mg 59.8%). Other improvements were seen in Cutaneous Lupus Erythematosus Disease Area and Severity Index score (200 mg and 1200 mg monthly), Physician's Global Assessment (600 mg and 1200 mg monthly), British Isles Lupus Assessment Group-based Composite Lupus Assessment (1200 mg monthly), 4-point reductions in the SLE Disease Activity Index-2000 score and reductions in counts of swollen joints and tender joints. Serious adverse events occurred in 17.6% of patients on placebo and 18.3% of patients on sifalimumab. Herpes zoster infections were more frequent with sifalimumab treatment.

conclusionsSifalimumab is a promising treatment for adults with SLE. Improvement was consistent across various clinical end points, including global and organ-specific measures of disease activity. TRIAL REGISTRATION NUMBER: NCT01283139; Results.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntigensCytoskeletal ProteinsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHumansLupus Erythematosus, SystemicMaleMembrane ProteinsMiddle AgedOxidoreductases Acting on CH-CH Group DonorsProteinsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntigensCytoskeletal ProteinsIFI27 protein, humanIFI44 protein, humanMembrane ProteinsOxidoreductases Acting on CH-CH Group DonorsProteinsRSAD2 protein, humansifalimumabViperin ProteinAutoimmune DiseasesSystemic Lupus ErythematosusTreatment

Identifiers

PMID27009916
PMCPMC5099191

What OpenQuestion holds

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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.