Table 1.

Summary of studies evaluating anti-TNF agents in systemic sclerosis.

Study Characteristics	Lam²⁶	Denton²⁸	Bosello²⁷	Ellman²⁹	Marie⁴⁸
Anti-TNF agent	Etanercept	Infliximab	Infliximab, Etanercept	Etanercept	Infliximab
Study design	Observational	Observational	Observational	Observational	Observational
Sample size, n	18	16	4	10, 1 discontinued after 4 wks	1
Country	USA	UK	Italy	USA	France
Study/treatment duration	Mean 30 mo (range 2–66 mo)	26 wks	6 mo	6 mo	2 wks
Other immunosuppressive medication	MTX 9/18 HCQ 5/18 Pred 9/18 Minocycline 2/18	None	MTX with infliximab	Not specified	Pred
Outcome
Skin score	Improved, not significant^a	No effect^d	Improved, not significant^{^**}	4/9 (44%) improvement; 5/9 unchanged	NR
HAQ-DI	Improved, not significant^b	Improved, not significant^*	Improved, not significant^†	Improved from 1.8 to 1.57^††	NR
HAQ-DI	Improved, not significant^b	Improved, not significant^*	Improved, not significant^†	Improved from 1.8 to 1.57^††	NR
Joint count	Improved^c	NR	NR	NR	NR
Adverse events	Lupus-like reaction 1/18, lung function decline 1/18	Infusion reactions, 44%	Not specified	n = 1 digital ischemia	A. meyeri pneumonia

↵a Mean Rodnan skin score (MRSS) decreased from 6.63 ± 6.35 to 3.94 ± 2.38 (p = 0.12).
↵b Mean HAQ-DI score decreased from 1.08 ± 0.70 to 0.74 ± 0.56 (p = 0.13).
↵c 15/18 (83%) patients treated with etanercept had a significant decrease in signs of inflammation/synovitis and resolution of joint symptoms.
↵d No significant change in median (range) baseline MRSS 26 (11–45) and Week 26 MRSS 22 (6–48).
↵* Nonsignificant improvement in median (range) baseline, HAQ-DI 1.63 (0–3), and Week 26, 1.5 (0–2.63) (p value not given).
↵** Baseline mean MRSS 17.75, 6-month MRSS 8.25 (p = 0.22).
↵† Baseline mean HAQ-DI 2.02, 6-month HAQ-DI 1.25 (p = 0.09).
↵†† p value not given. TNF-α: tumor necrosis factor-α; MTX: methotrexate; HCQ: hydroxychloroquine; Pred: prednisone; NR: not reported; HAQ-DI: Health Assessment Questionnaire-Disability Index.