B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial

Table 3 Demographic and clinical chracteristics of the study population

Patient	E/L	Disease duration (months)	Auto-antibodies	Follow-up duration (months)	FVC at baseline	FVC at the end of follow up	DLCO at baseline	DLCO at the end of follow up	Musculoskeletal involvement	Ulcers	Renal/cardiac/GI involvement	Concomitant medications
1	E	13	ANA	36	89%	104%	55%	54%	myositis	N	N/Y/Y	MTX
2	L	240	Scl70	36	101%	113%	52%	61%	arthritis	Y	N/N/Y	MTX
3	E	12	ANA	12	105%	96%	65%	69%	N	N	N/N/Y	-
4	E	24	Scl70	24	98%	101%	72%	65%	N	Y	N/N/Y	-
5	E	12	Scl70	18	100%	113%	56%	43%	N	Y	N/Y/Y	-
6	E	24	Scl70	6	95%	94%	86%	85%	N	Y	N/N/Y	-
7	E	24	ANA	6	44%	57%	54%	40%	N	Y	N/N/Y	-
8	E	32	SCL70	6	77%	78%	28%	47%	N	Y	N/Y/Y	-
9	L	60	SCL70	6	115%	115%	54%	62%	N	Y	N/N/Y	-

All patients had a diffuse cutaneous disease.
Renal involvement was defined as antecedent scleroderma crisis or the presence of proteinuria or elevation of creatinine serum level.
Cardiac involvement was defined as the presence of conduction disturbance, left ventricular ejection fraction less than 55%, pulmonary artery systolic pressure more than 35 mmHg or presence of myocarditis.
Gastro-intestinal involvement was defined as presence of gastro-oesophageal reflux symptoms or the evidence of gastrointestinal motility disturbance by barium swallow.
Concomitant medications: treatment other than iloprost by an infusion of 0.5 to 2 ng/Kg/minute, lasting six hours, for five days every two months, calcium-channel blockers (nifedipine 20 to 40 mg/day) and acetylsalicylic acid.
The number, that identifies each patient, corresponds to the number of the patient in Figures 1 and 2.
ANA, antinuclear autoantibodies; DLCO, diffusing capacity for carbon monoxide; E, early disease (disease duration <3 years); FVC, forced vital capacity; GI, gastrointestinal; L, long disease (disease duration >3 years); MTX, methotrexate; N, no; Scl70, antitopoisomerasi I antibodies; Y, yes.

ISSN: 1478-6362