Table 1.
Annual rate of decline in FVC, proportions of patients with worsening of FVC and stable or improved FVC, and changes in the MRSS from baseline to week 52 in patients with systemic sclerosis–associated interstitial lung disease in each treatment group in the SENSCIS trial, according to baseline ATA status
| ATA‐positive | ATA‐negative | ||||
|---|---|---|---|---|---|
| Variable | Nintedanib (n = 173) | Placebo (n = 177) | Nintedanib (n = 115) | Placebo (n = 111) | P for interaction* |
| Annual rate of decline in FVC (ml/year)† | |||||
| Adjusted rate of decline in FVC over 52 weeks, ± SE, ml/year | –63.6 ± 18.0 | –93.5 ± 17.3 | –35.9 ± 21.8 | –93.1 ± 21.9 | |
| Adjusted difference (95% CI) vs. placebo, ml/year‡ | 29.9 (–19.1, 78.8) | 57.2 (–3.5, 118.0) | 0.49 | ||
| Proportion of patients meeting proposed MCID thresholds for worsening of FVC and stable or improved FVC at week 52†§ | |||||
| Decrease in FVC ≥3.3% predicted, no. (%) | 62 (35.8) | 81 (45.8) | 37 (32.5) | 45 (40.5) | |
| Odds ratio (95% CI) vs. placebo‡ | 0.66 (0.43, 1.02) | 0.70 (0.41, 1.22) | 0.86 | ||
| Increase in FVC or decrease in FVC <3.3% predicted, no. (%) | 111 (64.2) | 96 (54.2) | 77 (67.5) | 66 (59.5) | |
| Odds ratio (95% CI) vs. placebo‡ | 1.51 (0.98, 2.32) | 1.42 (0.82, 2.45) | 0.86 | ||
| Change from baseline in MRSS at week 52¶ | |||||
| Adjusted change in MRSS at week 52, mean ± SE | –1.5 ± 0.3 | –1.7 ± 0.3 | –3.2 ± 0.4 | –2.4 ± 0.4 | |
| Adjusted difference (95% CI) vs. placebo‡ | 0.2 (–0.7, 1.2) | –0.8 (–2.0, 0.4) | 0.18 | ||
P values evaluated heterogeneity in the treatment effect of nintedanib versus placebo between the subgroups; annual rate of decline in forced vital capacity (FVC), P for treatment‐by‐time‐by‐subgroup interaction; proportions of patients meeting proposed minimum clinically important difference (MCID) thresholds for worsening of FVC and stable or improved FVC at week 52, P for treatment‐by‐subgroup interaction; change from baseline in the modified Rodnan skin thickness score (MRSS), P for treatment‐by‐visit‐by‐subgroup interaction.
Post–baseline FVC data were not available for 1 anti–topoisomerase I antibody (ATA)–negative patient in the nintedanib group; this patient was excluded from the analysis.
95% CI = 95% confidence interval.
The proposed MCID thresholds for worsening of FVC and stable or improved FVC were based on estimates derived from the Scleroderma Lung Studies I and II, anchored to the health transition question from the Medical Outcomes Short Form 36 (24).
Baseline MRSS data were not available for 2 ATA‐positive patients in the placebo group; these patients were excluded from the analysis.