MétaCan
Menu
Back to cohort
Record W2965009353 · doi:10.1016/j.jaad.2019.07.074

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

2019· article· en· W2965009353 on OpenAlex
Mette Deleuran, Diamant Thaçi, Lisa A. Beck, Marjolein de Bruin‐Weller, Andrew Blauvelt, Seth Forman, Robert Bissonnette, Kristian Reich, Weily Soong, Iftikhar Hussaın, Peter Foley, Michihiro Hide, Jean‐David Bouaziz, Joel M. Gelfand, Lawrence Sher, Marie L. A. Schuttelaar, Chen Wang, Zhen Chen, Bolanle Akinlade, Abhijit Gadkari, Laurent Eckert, John D. Davis, Manoj Rajadhyaksha, Heribert Staudinger, Neil M.H. Graham, Gianluca Pirozzi, Marius Ardeleanu

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.
fundA Canadian funder is recorded on the work.

Bibliographic record

VenueJournal of the American Academy of Dermatology · 2019
Typearticle
Languageen
FieldMedicine
TopicDermatology and Skin Diseases
Canadian institutionsInnovaderm (Canada)
FundersGenentechLEO PharmaCoherus BiosciencesKaken PharmaceuticalAsana BiosciencesKiniksa PharmaceuticalsAimmune TherapeuticsJanssen BiotechTeva Pharmaceutical IndustriesLes Laboratories Pierre FabreValeant Pharmaceuticals InternationalGaldermaUCBRegeneron PharmaceuticalsSun PharmaDermiraTherakosTaiho PharmaceuticalF. Hoffmann-La RocheGlenmark PharmaceuticalsAbbVieNovartisCelgeneBoehringer IngelheimAmgenSanofi GenzymeMerck Sharp and Dohme3MRocheUniversity of PennsylvaniaKyowa Hakko KirinSanofiMerckGlaxoSmithKlineIncytePfizerAllerganAstraZenecaEli Lilly and Company
KeywordsDupilumabMedicineAtopic dermatitisOpen labelDermatologyTerm (time)Adverse effectInternal medicine

Abstract

fetched live from OpenAlex

BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD). OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD. METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated. RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life. LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks. CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.041
Threshold uncertainty score0.528

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.016
GPT teacher head0.325
Teacher spread0.308 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it