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P258 Secukinumab Improves Physical Function and Inhibits Structural Damage in Psoriatic Arthritis PsA Patients With Sustained Remission or Low Disease Activity: Results From a Phase 3 Study

2022· article· en· W4224318488 on OpenAlexaff
Laura C. Coates, Philip J. Mease, Dafna D. Gladman, Sandra Navarra, Weibin Bao, Corine Gaillez

Bibliographic record

VenueLara D. Veeken · 2022
Typearticle
Languageen
FieldMedicine
TopicSpondyloarthritis Studies and Treatments
Canadian institutionsToronto Western HospitalUniversity of Toronto
Fundersnot available
KeywordsSecukinumabMedicinePsoriatic arthritisPlaceboInternal medicinePhysical therapyClinical trialQuality of life (healthcare)DiseaseAlternative medicinePathology

Abstract

fetched live from OpenAlex

Abstract Background/Aims Disease Activity Index for Psoriatic Arthritis (DAPSA) or the minimal disease activity (MDA) are considered for defining remission (REM) or low disease activity (LDA) in secukinumab-treated patients with psoriatic arthritis (PsA). Currently, limited secukinumab data are available on patients with PsA achieving sustained REM in clinical trials or real-world evidence using these stringent criteria. This abstract reports an exploratory analysis of achievement of sustained REM/LDA in patients with PsA treated with secukinumab and impact on structural outcomes, physical function and health-related quality of life (HRQoL) in the FUTURE 5 study (NCT02404350). Methods FUTURE 5 is a randomised, double-blind, placebo-controlled, 2-year phase 3 trial in patients with active PsA. Patients randomised to secukinumab 150 mg could be escalated to 300 mg from week 52 to 104, based on investigators’ judgement. Patients were categorised as either not achieving REM/LDA, achieving it once only, or sustained REM/LDA (defined as patients achieving REM/LDA between weeks 24-52 and maintaining the same response at least 2 of the next 6 visits [visit every 8 weeks]). Of patients who did not achieve REM/LDA or who achieved REM/LDA (VLDA, DAPSA REM, MDA, DAPSA LDA+REM) between weeks 24 and 52, the relationships between: absence of REM/LDA; REM/LDA; sustained REM/LDA; proportion of patients with non-radiographic progression (assessed using the van der Heijde [mTSS]); physical function (health assessment questionnaire disability index [HAQ-DI]); and short form-36 physical component score [SF-36 PCS]) were assessed. Results 996 patients were randomised to 1 of 4 treatment groups: secukinumab 300 mg loading dose (LD; n = 222), secukinumab 150 mg LD (n = 220), secukinumab 150 mg no LD (NL; n = 222), and placebo (n = 332). The baseline clinical characteristics were comparable across treatment groups. Most patients achieved either sustained MDA or sustained DAPSA LDA+REM (Table). Patients achieving REM/LDA, whether at one visit or consistently, showed improved physical function and SF36-PCS at week 104. A high proportion of patients did not show radiographic progression at week 104 irrespective of achievement of REM/LDA category. Conclusion Most patients treated with secukinumab achieved a sustained LDA. Sustained LDA/REM was associated with improved HRQoL, physical function and inhibition of structural damage progression. Disclosure L.C. Coates: Consultancies; Abbvie, Amgen, Biogen, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; Abbvie, Celgene, Lilly, Novartis, Pfizer. P.J. Mease: Consultancies; AbbVie, Amgen, BMS, Boehringer Ingelheim, Galapagos, Celgene, GlaxoSmithKline, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, UCB. Member of speakers’ bureau; AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN, UCB. D.D. Gladman: Consultancies; Abbvie, Amgen, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, UCB. Grants/research support; Abbvie, Amgen, Celgene, Eli Lilly, Novartis, Pfizer, UCB. S. Navarra: Consultancies; Pfizer, Novartis, Astra-Zeneca, Janssen, Lilly, Astellas. Member of speakers’ bureau; Pfizer, Novartis, Astra-Zeneca, Janssen, Lilly, Astellas. W. Bao: Shareholder/stock ownership; Novartis. Other; Employee of Novartis. C. Gaillez: Shareholder/stock ownership; Novartis, BMS. Other; Employee of Novartis.

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.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.003
Threshold uncertainty score0.012

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.001
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0020.002
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0010.001
Open science0.0000.000
Research integrity0.0010.002
Insufficient payload (model declined to judge)0.0030.001

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 head0.007
GPT teacher head0.255
Teacher spread0.247 · 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

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations0
Published2022
Admission routes1
Has abstractyes

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