261 Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 4-year results from the Phase 3 trial, MEASURE 2
Bibliographic record
Abstract
Background: Secukinumab (SEC), a fully human monoclonal antibody that neutralises interleukin-17A, has shown significant and sustained improvement in the signs and symptoms of active ankylosing spondylitis (AS) through 3 years in the MEASURE 2 study (NCT01649375). Objectives: To report the longer-term (4 year) efficacy and safety of subcutaneous (s.c.) SEC 150 mg in the MEASURE 2 study. Methods: AS patients (n = 219) were randomised to receive s.c. SEC 150 mg (approved dose), 75 mg or placebo (PBO) at baseline (BL), weeks (weeks) 1, 2 and 3, and every 4 weeks from week 4. At week 16, PBO-treated patients were re-randomised to receive SEC 150/75 mg. Efficacy results are reported for pts initially randomised to SEC 150 mg and those who switched from PBO to SEC 150 mg at week 16. Safety analyses included all patients who received ≥1 dose of SEC. Results are reported as observed. Results: The retention rate from week 16 to 208 was 85% (85/100) for SEC 150 mg. Sustained improvements were observed with SEC 150 mg across all endpoints through 4 years (Table 1). These improvements were maintained regardless of prior exposure to anti-tumour necrosis factor (TNF) therapy; greater responses were demonstrated in anti-TNF-naive patients. Over the entire study period, the mean exposure (±standard deviation [SD]) to SEC was 1189.3±452.9 days. Exposure-adjusted incidence rates (per 100 patient-years) with any SEC dose for selected adverse events were: serious infections/infestations (1.5), Candida infections (1.2), Crohn’s disease (0.6), major adverse cardiovascular events (0.6), uveitis (0.6), and malignant/unspecified tumours (0.4). Conclusion: SEC 150 mg provided sustained improvement in signs, symptoms and physical function in patients with AS through 4 years of treatment, with 85% retention rate. The safety profile of SEC remained favourable and was consistent with previous reports. Clinical improvements with SEC 150 mg at Wks 52 and 208 Includes PBO switchers. Data are reported as observed. ASAS, Assessment in Spondyloarthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; IR, inadequate response; PBO, placebo; SD, standard deviation; SEC, secukinumab; SF-36 PCS, Short Form 36 Health Survey Physical Component Summary; TNF, tumour necrosis factor; Wk, week. Disclosures: H. Marzo-Ortega: Member of speakers’ bureau; H. M. participated in speaker bureaus for: AbbVie, Celgene, Janssen, Novartis, Pfizer and UCB. Grants/research support; H. M. received grant/research support from: Celgene and Janssen. J. Sieper: Consultancies; J. S. consulted for: AbbVie, Merck, Novartis, Pfizer and UCB. Member of speakers’ bureau; J. S. participated in speaker bureaus for: AbbVie, Merck, Pfizer and UCB. Grants/research support; J. S. received grant/research support from: AbbVie, Merck and Pfizer. A. Kivitz: Consultancies; A. K. consulted for: AbbVie, Amgen, Boehringer Ingeleheim, Celgene and Genetech. Grants/research support; A. K. received grant/research support from: Altoona Centre for Clinical Research. R. Blanco: Consultancies; R. B. consulted for: AbbVie, Bristol-Myers, Janssen, Lilly, MSD, Pfizer and Roche. Member of speakers’ bureau; R. B. participated in speaker bureaus for: AbbVie, Bristol-Myers, Janssen, Lilly, MSD, Pfizer and Roche. Grants/research support; R. B. received grant/research support from: AbbVie, MSD and Roche. M. Cohen: Consultancies; M. C. consulted for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Paladin, Pfizer, Roche, Sanofi and UCB. E. Delicha: Other; M. D. is an employee of Novartis. S. Rohrer: Other; R. is an employee of Novartis. H. Richards: Other; H. R. is an 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 imitationNot 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.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".