O27 Subcutaneous Tocilizumab in Adults with Systemic Sclerosis: 24 and 48 Week Safety and Efficacy Data from the Fasscinate Trial
Bibliographic record
Abstract
Background: Interleukin-6 (IL-6) appears to play a key role in the pathogenesis of SSc, a debilitating disease with limited treatment options. Methods: A double-blind, placebo-controlled, phase 2, proof-of-concept study of the efficacy and safety of the IL-6 receptor inhibitor tocilizumab (TCZ) (weekly s.c. injection; TCZ 162 mg vs placebo for 48 weeks) in patients ≥18 years of age with active SSc. The primary end point was a mean change in the modified Rodnan skin score (mRSS) from baseline at week 24. Change in the mRSS at week 48, patient-reported outcomes (PROs) and pulmonary function (week 48) were exploratory measures. Results: A total of 87 patients (43 TCZ, 44 placebo) were enrolled [mean mRSS: TCZ 26 (s.d. 7.2), placebo 26 (s.d. 5.9)]. At week 24, a favourable effect of TCZ vs placebo on mRSS was noted (Table 1). With continuing treatment there was a numerically larger change in mRSS (Table 1). Higher proportions of TCZ vs placebo patients had mRSS improvement from baseline of ≥ 20% (40% vs 27%), ≥40% (21% vs 7%) or ≥ 60% (12% vs 0). Between weeks 24 and 48 there were numerically greater improvements in the TCZ arm for PROs [HAQ Disability Index (HAQ-DI), patient global assessment visual analogue scale and the Functional Assessment of Chronic Illness Therapy fatigue scale] (Table 1) and significantly more patients had HAQ-DI improvement ≥0.22 at week 48 [TCZ 28% vs placebo 7% (P = 0.01)]. Fewer TCZ vs placebo patients showed a decline in the per cent predicted forced vital capacity (%FVC; 57% vs 84%) and a > 10% absolute decrease in %FVC (10% vs 23%) at week 48 (Table 1). Adverse events (AEs)/serious AEs occurred in 98%/33% of TCZ and 91%/34% of placebo patients. By week 48, there were four deaths (one placebo and three TCZ), unrelated to the study drug except for a fatal lung infection in one TCZ patient.
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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 | 0.001 | 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) | 0.003 | 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".