Table 2.

Primary outcome: adverse events and the concomitant treatments per patient

Episodes (months)	−3–0	0–3	3–6	6–9	9–12	Monthly Incidence Pre-MSC	Monthly Incidence Post-MSC	Incidence /person/month Pre-MSC	Incidence /person/month Post-MSC	P-value
Serious Adverse Events
Pt 1	Hematemesis faecal impaction	Fecal impaction	-	Fecal impaction	-	0.67	0.17	0.111	0.055	0.60
Pt 2		-	-	-	Bilateral pneumonia	0	0.08
Pt 3	-	-	-	-	-	0	0
Pt 4	-	-	-	-	-	0	0
Pt 5	-	-	-	-	-	0	0
Pt 6	-	-	Evolving MAS	-	-	0	0.08
Total	2	1	1	1	1	0.67	0.33
Adverse Events
Pt 1	-	-	-	-	-	0	0	0.055	0.014	0.36
Pt 2	-	-	-	-	-	0	0
Pt 3	Flu-like illness	-	URTI		-	0.33	0.08
Pt 4	-	-	-		-	0	0
Pt 5	-	-	-	-	-	0	0
Pt 6	-	-	-	-	-	0	0
Total	1	0	1	0	0	0.33	0.08
Anti-rheumatic therapy
Pt 1	(Wk -5 Toclilizumab) MTX 25mg/wk sc	Wk 0 & 11: MSC MTX 25mg/wk po	MTX 25mg/wk po	MTX 25mg/wk po	MTX 25mg/wk po
Pt 2	Pred. 10 mg/d	Wk 0: MSC Pred. 10 mg/d	Pred. 10 mg/d	Wk 28 & 30 Rituximab Pred. 10 mg/d	Pred. 10 mg/d
Pt 3	(Wk -10 Tocilizumaba) Pred. 12.5 mg/d	Wk 0: MSC Pred. 12.5 mg/d	Pred. 12.5 mg/d	Pred. 12.5 mg/d	Pred. 12.5 mg/d
Pt 4	(Wk -5 Abatacept) Pred. 5mg/d MTX 7.5 mg/wk po	Wk 0 & 10: MSC Pred. 5mg/d MTX 7.5 mg/wk	Wk 23: Sirolimus 2mg/d Pred. 7.5mg/d Wk 22: MMF 1500mg/d	Wk 38: IA steroids (4) Wk 38: Etanercept Pred. 10mg/d MMF 1500mg/d	Etanercept 50mg/10d Pred. 7.5mg/d MMF 1500mg/d
Pt 5	Pred. 14 mg/d	Wk 0 & 8: MSC Pred. 14 mg/d	Wk 13: IA steroidsb Wk 16: Adalimumab Pred. 10 mg/d Wk 13: MTX 15mg/wk sc	Wk 32: MMF 1000mg/d Adalimumab 40mg/wk Pred. 5 mg/d MTX 20 mg/wk sc	MMF 1500mg/d Adalimumab 40mg/wk Pred. 2.5 mg/d MTX 20 mg/wk sc
Pt 6	(Wk-2 Tocilizumab) Pred 2 mg/d MTX 25 mg/wk po	Wk 0: MSC Wk 9: MP 3x pulse Wk 9: Tocilizumab /e.o.w. Wk 9: Pred. 60->30 mg/d MTX 25 mg/wk po	Tocilizumab / e.o.w. Pred. 30->10 mg/d MTX 25mg/wk po	Tocilizumab / e.o.w. Pred. 10->5 mg/d MTX 25mg/wk po	Wk 39: MMF 1440mg/d Tocilizumab / e.o.w. Pred. 2 mg/d MTX 25mg/wk po

Serious and moderate-severe adverse events are shown for 3-month periods before and 12 months after the first MSC-infusion. Also, the anti-rheumatic medication given during the study is shown per patient; therapy changes are in bold. The biologics used prior to week 0 are between brackets with their last administrations displayed. Incidences are displayed per patient/month. The two-sided χ² test (Fisher’s exact) for related samples was used for statistical analysis of the incidences of events per person per month comparing the Pre-MSC with the Post-MSC episode.

^asubcutaneous.

^b5 joints injected.

e.o.w: every other week; MP: methylprednisolone; MSC: mesenchymal stromal cells; po: per os; Pred: prednisolone; URTI: upper respiratory tract infection; Wk: week.