P250 Effect of secukinumab on radiographic progression through 2 years in patients with active PsA: end-of-study results from a Phase 3 study
Bibliographic record
Abstract
Abstract Background Secukinumab demonstrated sustained efficacy, inhibition of radiographic progression and a stable safety profile over 52 weeks in patients with psoriatic arthritis (PsA) in FUTURE 5. We report the end-of-study (2-year) results on the effect of secukinumab on radiographic progression in PsA patients in FUTURE 5. Methods Adults (N = 996) with active PsA were randomised to subcutaneous secukinumab 300 mg load, 150 mg load, 150 mg no load or placebo at baseline, Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. The secukinumab dose could be escalated from 150 to 300 mg from Week 52 onwards, based on physician judgement. Radiographic progression (mean change in vdH-mTSS) was based on hand/wrist/foot radiographs obtained at baseline, and Weeks 16 (nonresponders), 24, 52 and 104, assessed by two blinded readers (plus an adjudicator if required). Radiographic data were analysed using a linear mixed-effects model (random intercept, random slopes) at Weeks 24 and 52, and as observed at Week 104. Data are presented for patients originally randomised to secukinumab (300 and 150 mg); the 150 mg groups also included patients who had dose escalation to 300 mg. Analyses by prior TNF inhibitor (TNFi) status (naive vs inadequate response) were also performed. Results Overall, 85% (300 mg), 82% (150 mg) and 75% (150 mg no load) of patients completed 2 years of treatment. A total of 86 (39%) and 92 (41%) patients had their dose escalated to 300 mg in the 150 mg and 150 mg no load groups, respectively. In the overall population, the proportions of patients with no radiographic progression (change from baseline in vdH-mTSS≤0.5) with secukinumab were 89.5% (300 mg), 82.3% (150 mg) and 81.1% (150 mg no load) at 2 years; the corresponding proportions of patients with changes from baseline in vdH-mTSS≤0.0 were: 81.2%, 69.1% and 73.4%, respectively. Radiographic progression was low in secukinumab-treated patients in the overall population and by prior TNFi use over 2 years (Table 1). Clinical responses were sustained through 2 years of secukinumab treatment. Conclusion Low radiographic progression was observed over 2 years of treatment with secukinumab 300 and 150 mg in PsA patients. Disclosures H. Tahir: Member of speakers’ bureau; AbbVie, Janssen, Eli Lilly, Novartis. Grants/research support; Novartis, Eli Lilly. P. Mease: Consultancies; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, INC pharma, UCB, Crescendo Bioscience. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer, UCB, Crescendo Bioscience. Grants/research support; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, INC pharma, UCB, Crescendo Bioscience. R. Landewé: None. P. Rahman: Consultancies; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, UCB. Member of speakers’ bureau; AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis. Grants/research support; Janssen, Novartis. A. Singhal: Grants/research support; AbbVie, Gilead, Sanofi, Regeneron, Amgen, Roche, Bristol-Myers Squibb, Janssen, Lilly, Novartis, Pfizer, UCB, Astra Zeneca, MedImmune, FujiFilm, Nichi-Iko, Mallinckrodt. E. Böttcher: Consultancies; Amgen, Roche, Eli Lilly, Pfizer, MSD, Novartis. Member of speakers’ bureau; Amgen, Roche, Eli Lilly, Pfizer, MSD, Novartis. S. Navarra: Member of speakers’ bureau; Astellas, Johnson & Johnson, Novartis, Pfizer. A. Readie: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. S. Mpofu: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. E. Delicha: Consultancies; Novartis. L. Pricop: Shareholder/stock ownership; Novartis. Other; Employee of: Novartis. D. van der Heijde: Corporate appointments; Imaging Rheumatology BV. Consultancies; AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma.
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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 | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 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".