Table 2– End-point analyses
Patients in the lung group n444246
ΔFVC % predicted at week 16
 95% CI-0.65–4.69-1.64–3.95-2.68–2.38
ΔFVC % predicted at week 28
 95% CI-1.62–4.79-3.07–3.65-2.48–3.60
Δ6MWD at week 28
 Mean±se m14.52±14.22312.53±14.919-13.22±13.584
 95% CI-13.63–42.66-16.99–42.06-40.10–13.67
ΔSGRQ total score at week 28
 95% CI-15.02– -3.98-12.64– -1.08)-9.52–1.01
Patients in the skin group n201721
Patients with a SPGA score ≤1 n
 Responders n (%)6 (30)9 (52.9)3 (14.3)
  • ΔFVC%: change from baseline in forced vital capacity; Δ6MWD: change from baseline in 6-min walking distance; ΔSGRQ: change from baseline in the St. George's Respiratory Questionnaire; SPGA: Skin Physician Global Assessment. #: the overall p-value is based on the F-test; : means are reported as least square means; +: treatment comparisons are based on linear contrasts; §: treatment comparisons are based on Fisher's exact test.