Evidence map›Paper›PMID 32107560›Full record

Trial reportRheumatology (Oxford, England)2020

Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study.

Eric F Morand, David A Isenberg, Daniel J Wallace, Amy H Kao, Cristina Vazquez-Mateo, Peter Chang, Kishore Pudota, Cynthia Aranow, Joan T Merrill

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

Trial report in Rheumatology (Oxford, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01972568 (A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus), which is not on this map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
5.8field-weighted citation impact, top 3% 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.

NCT01972568 phase2completednot on this map

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

TypeinterventionalSponsorEMD SeronoRan2013 to 2016Enrolled306ConditionsLupus Erythematosus, SystemicArmsAtacicept 75 milligram (mg), Atacicept 150 mg, Placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 48 citations in OpenAlex.

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  13. Precision medicine in systemic lupus erythematosus.Nature reviews. Rheumatology · 2023
    Review
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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

9 authors at 6 institutions in 4 countries.

Eric F MorandCentre for Inflammatory Disease, Monash University, Melbourne, Australia.
David A IsenbergCentre for Rheumatology, University College London, London, UK.
Daniel J WallaceDivision of Rheumatology, Cedars-Sinai Medical Center, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA.
Amy H KaoEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
Cristina Vazquez-MateoEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
Peter ChangEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
Kishore PudotaEMD Serono Research & Development Institute, Inc. (A Business of Merck KGaA, Darmstadt, Germany), Billerica, MA, USA.
Cynthia AranowInstitute of Molecular Medicine, Feinstein Institute for Medical Research, Manhasset, NY, USA.
Joan T MerrillClinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA.
Merck (Germany) · DECedars-Sinai Medical Center · USFeinstein Institute for Medical Research · USMonash University · AUOklahoma Medical Research Foundation · USUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveLow disease activity (LDA) and remission are emerging treat-to-target (T2T) endpoints in SLE. However, the rates at which these endpoints are met in patients with high disease activity (HDA) are unknown. Atacicept, which targets B lymphocyte stimulator and a proliferation-inducing ligand, improved disease outcomes in SLE patients with HDA (SLEDAI-2K ≥10) at baseline in the phase 2b ADDRESS II study. This is a post hoc analysis of T2T endpoints in these patients.

methodsPatients received weekly atacicept (75 or 150 mg s.c.) or placebo for 24 weeks (1:1:1 randomization). Attainment of three T2T endpoints, LDA (SLEDAI-2K ≤ 2), Lupus Low Disease Activity State (LLDAS) and remission (clinical SLEDAI-2K = 0, prednisone-equivalent ≤5mg/day and Physician's Global Assessment <0.5), was assessed and compared with SLE Responder Index (SRI)-4 and SRI-6 response.

resultsOf 306 randomized patients, 158 (51.6%) had baseline HDA. At week 24, 37 (23.4%) HDA patients attained LDA, 25 (15.8%) LLDAS and 17 (10.8%) remission. Each of these endpoints was more stringent than SRI-4 (n = 87; 55.1%) and SRI-6 (n = 67; 42.4%). Compared with placebo (n = 52), at week 24, patients treated with atacicept 150 mg (n = 51) were more likely to attain LDA [odds ratio (OR) 3.82 (95% CI: 1.44, 10.15), P = 0.007], LLDAS [OR 5.03 (95% CI: 1.32, 19.06), P = 0.018] or remission [OR 3.98 (95% CI: 0.78, 20.15), P = 0.095].

conclusionAt week 24, LDA, LLDAS and remission were more stringent than SRI-4 and SRI-6 response, were attainable in the HDA population and discriminated between treatment with atacicept 150 mg and placebo. These results suggest that T2T endpoints are robust outcome measures in SLE clinical trials and support further evaluation of atacicept in SLE. TRAIL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01972568.

Indexed as

AdultDouble-Blind MethodFemaleHumansLupus Erythematosus, SystemicMaleOdds RatioPlacebosRecombinant Fusion ProteinsRemission InductionTreatment OutcomePlacebosRecombinant Fusion ProteinsTACI receptor-IgG Fc fragment fusion proteinataciceptlow disease activitylupus low disease activity stateremissionSLEtreat to target

Identifiers

PMID32107560
PMCPMC7516108
OpenAlexW3007483088

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.