256 Secukinumab provides sustained improvements in the signs and symptoms of active psoriatic arthritis: 4-year results from the Phase 3 FUTURE 2 study
Bibliographic record
Abstract
Background: Secukinumab (SEC), a fully human monoclonal antibody that selectively neutralises interleukin-17A, provided significant and sustained improvement in the signs and symptoms of active psoriatic arthritis (PsA) over 2 years in the FUTURE 2 study (NCT01752634). Objectives: To report 4-year efficacy and safety results from the FUTURE 2 study. 3-year data is presented here, with 4-year data to follow. Methods: Overall, 397 patients with active PsA were randomised to receive subcutaneous SEC (300, 150 or 75 mg) or placebo (PBO) at baseline (BL), Weeks 1, 2, 3 and 4, and every 4 weeks thereafter. Assessments at week 156 are from patients originally randomised to SEC and included ACR20/50, PASI 75, HAQ-DI, and resolution of dactylitis and enthesitis. Analyses by prior anti-tumour necrosis factor (TNF) use (naive/inadequate response [IR]) and with/without concomitant methotrexate (MTX) were assessed. Data are reported as observed for SEC 300 and 150 mg (approved doses). Safety analyses included all patients who received ≥1 dose of SEC. Results: In total, 73/100 (73.0%) and 72/100 (72.0%) patients in the SEC 300 and 150 mg groups, respectively, completed 156 weeks of treatment. Sustained clinical improvements were observed in those continuing with SEC across all endpoints through week 156 (Table 1). ACR20 response rates at week 156 in anti-TNF-naive patients were 85.2% and 76.5% with SEC 300 and 150 mg respectively; corresponding rates in anti-TNF-IR patients were 55.6% and 54.5%, respectively. ACR20 response rates in patients receiving concomitant MTX were 73.0% and 77.1% with SEC 300 and 150 mg, respectively; rates in patients without concomitant MTX use were 77.3% and 63.2%, respectively. Over the study (mean SEC exposure of 991.3 days) the type, incidence and severity of adverse events (AEs) were consistent with that reported previously. Exposure adjusted incidence rates with SEC for selected AEs of interest were: serious infections (1.8), Candida infections (1.8), inflammatory bowel disease (0.1), major adverse cardiovascular event (0.2) and malignant/unspecified tumours (1.2). Conclusion: SEC 300 and 150 mg provided sustained improvements in the signs and symptoms of active PsA through 3 years. Secukinumab was well tolerated, with a safety profile consistent with that reported previously. Summary of efficacy results at Wk 156 PASI responses assessed in pts with psoriasis affecting ≥3% body surface area at BL (n = 41 [300 mg] and n = 58 [150 mg]); Assessed in pts (n = 56 [300 mg] and n = 64 [150 mg]) with this symptom at BL; Assessed in pts (n = 46 [300 mg] and 32 [150 mg]) with this symptom at BL. SEC 150 mg arm includes 42 pts who were up-titrated to SEC 300 mg starting at Wk 128. ACR, American College Rheumatology; BL, baseline; HAQ-DI, health assessment questionnaire-disability index; N, number of pts randomised; n, number of pts with evaluation; PASI, psoriasis area and severity index; pts, patients; SEC, secukinumab; s.c., subcutaneous; Wk, week. Disclosures: I.B. McInnes: Consultancies; I. M. consulted for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Member of speakers’ bureau; I. M. participated in speaker bureaus for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. Grants/research support; I. M. received grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, UCB. B. Kirkham: Consultancies; B. K consulted for: AbbVie, Janssen, Lilly, MSD, Novartis. B. K.. Member of speakers’ bureau; B. K. participated in speaker bureaus for: Janssen, Lilly, Novartis. Grants/research support; B. K. received grant/research support from: AbbVie, Lilly, Novartis, UCB. P. Nash: Consultancies; P. N. consulted for: Novartis, AbbVie, Roche, Pfizer, BMS, Janssen, Celgene. Grants/research support; P. N. received grant/research support from: Novartis, AbbVie, Roche, Pfizer, BMS, Janssen, Celgene. P. Rahman: Consultancies; P. R. consulted for: Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer Roche and pharmaceutical companies dealing with biologic agents in rheumatology. A.B. Gottlieb: Consultancies; A.G. consulted for: AbbVie, Allergan, Bristol Myers Squibb Co., Beiersdorf, Inc., Celgene Corp., Dermira, Incyte, Janssen Inc., Lilly, Novartis, Reddy Labs, Sun Pharmaceutical Industries, UCB, Valeant. Member of speakers’ bureau; A.G. participated in speaker bureaus with: AbbVie, Allergan, Beiersdorf, Inc., Grants/research support; A. G. received grant/research support from: Janssen, Incyte. K. Ding: Shareholder/stock ownership; K. D. is a shareholder at Novartis. Other; K. D. is an employee of Novartis. L. Pricop: Shareholder/stock ownership; L. P. is a shareholder at Novartis. Other; L. P. is an employee of Novartis.
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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 | 0.003 | 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 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".