169 Secukinumab provides sustained reduction in fatigue in patients with active psoriatic arthritis through three years: long-term data from the FUTURE 1 and FUTURE 2 studies
Bibliographic record
Abstract
Background: Fatigue is common in patients with psoriatic arthritis (PsA) and negatively impacts social functioning and quality of life. We assessed the long-term effects of secukinumab on fatigue in TNF inhibitor (TNFi)-naïve PsA patients and those with inadequate response or intolerance to TNFi therapy (TNFi-IR). Methods: 606 and 397 participants were randomised to secukinumab or placebo in FUTURE 1 (10 mg/kg i.v. followed by 150 or 75 mg S.C.) and FUTURE 2 (300, 150 or 75 mg S.C.), respectively. Fatigue was assessed at baseline and weeks 4, 8, 12, 16, 24, 52, 104 and 156 (FUTURE 1 only) using FACIT-Fatigue (higher score=less fatigue). Fatigue response was defined as increase in FACIT-Fatigue score of ≥ 4 from baseline (corresponding to the minimal clinically important difference). Correlations between baseline characteristics and improvements in fatigue were investigated using a logistical regression model. Only data for approved doses of secukinumab are shown. Results: FACIT-Fatigue was 27.8-28.9 and 26.6-29.2 at baseline across groups in FUTURE 1 and 2, respectively. Observed improvements in fatigue with all doses of secukinumab vs. placebo at Weeks 4-24 were sustained through 156 weeks in FUTURE 1 and 104 weeks in FUTURE 2 in both the overall population and subgroups stratified by prior TNFi exposure (Table 1). The numerically higher responses with secukinumab 150 vs. 300 mg in the observed analysis resulted from a higher discontinuation rate due to lack of efficacy with the lower dose, thus inflating the response rate. In the overall population, the least-squares mean change (±standard error) from baseline in FACIT-Fatigue was significantly greater with secukinumab vs. placebo at week 16 in both FUTURE 1 (7.25±0.72 vs. 4.07±0.76; p = 0.002) and FUTURE 2 (300 mg: 5.89±0.92 vs. 1.86±0.93, p = 0.002; 150 mg: 7.40±0.90 vs. 1.86±0.93, p < 0.0001); improvements were sustained throughout the entire follow up in both studies (FUTURE 1 week 156: 6.14±0.77; FUTURE 2 Week 104: 300 mg 7.29±1.04, 150 mg 7.02±1.06). Improvements were numerically larger in TNFi-naïve patients than in TNFi-IR patients.
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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 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| 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 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
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.
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".