Evidence map›Paper›PMID 29513931›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2018

Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis.

Laurence E Cheng, Zahir Amoura, Benjamin Cheah, Falk Hiepe, Barbara A Sullivan, Lei Zhou, Gregory E Arnold, Wayne H Tsuji, Joan T Merrill, James B Chung

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 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.

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

45 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  4. Targeting T follicular helper cells for lifelong health.Nature reviews. Drug discovery · 2026
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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.

Laurence E ChengAmgen, Thousand Oaks, California.
Zahir AmouraHôpital Pitié-Salpêtrière, Paris, France.
Benjamin CheahInternational Medical University, Kuala Lumpur, Malaysia.
Falk HiepeCharité Universitätsmedizin Berlin, Berlin, Germany.
Barbara A SullivanAmgen, Thousand Oaks, California.
Lei ZhouAmgen, Thousand Oaks, California.
Gregory E ArnoldAmgen, Thousand Oaks, California.
Wayne H TsujiAmgen, Thousand Oaks, California.
Joan T MerrillOklahoma Medical Research Foundation, Oklahoma City.
James B ChungAmgen, Thousand Oaks, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and potential efficacy of AMG 557, a fully human antibody directed against the inducible T cell costimulator ligand (ICOSL) in patients with systemic lupus erythematosus (SLE) with arthritis.

methodsIn this phase Ib, randomized, double-blind, placebo-controlled study, patients received AMG 557 210 mg (n = 10) or placebo (n = 10) weekly for 3 weeks, then every other week for 10 additional doses. The corticosteroid dosage was tapered to ≤7.5 mg/day by day 85, and immunosuppressants were discontinued by day 29. Primary end points on day 169 were safety, immunogenicity, the Lupus Arthritis Response Index (LARI; defined by a reduction in the tender and swollen joint counts), ≥1-letter improvement in the musculoskeletal domain of the British Isles Lupus Assessment Group (BILAG) index, and medication discontinuation. The secondary/exploratory end points were changes in the tender and swollen joint counts, BILAG index scores (musculoskeletal, global), and the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI).

resultsThe incidence of adverse events, most of which were mild, was similar between groups. LARI responses occurred in 3 of 10 patients receiving AMG 557 and 1 of 10 patients receiving placebo (P = 0.58). More patients in the AMG 557 group achieved a ≥4-point improvement in the SLEDAI score on day 169 (7 of 10 patients) compared with the placebo group (2 of 10 patients) (P = 0.07). Patients treated with AMG 557 (versus placebo) had greater improvements from baseline in the global BILAG index scores (-36.3% versus -24.7%) and the SLEDAI score (-47.8% versus -10.7%) and in tender (-22.8% versus -13.5%) and swollen (-62.1% versus -7.8%) joint counts on day 169.

conclusionAMG 557 showed safety and potential efficacy, supporting further evaluation of the clinical efficacy of ICOSL blockade in patients with SLE.

Indexed as

AdolescentAdrenal Cortex HormonesAdultAgedAntibodies, Monoclonal, HumanizedArthritisDouble-Blind MethodFemaleHumansImmunosuppressive AgentsInducible T-Cell Co-Stimulator LigandJointsLupus Erythematosus, SystemicMaleMiddle AgedSeverity of Illness IndexAdrenal Cortex HormonesAMG 557Antibodies, Monoclonal, HumanizedImmunosuppressive AgentsInducible T-Cell Co-Stimulator Ligand

Identifiers

PMID29513931
PMCPMC6032945

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.