Table 1 Randomized controlled trials evaluating immunosuppressive/immunomodulatory drugs in patients with SSc.
Reference | Treatment | Number and main inclusion criteria of SSc patients | Study duration | Clinical effect |
|---|---|---|---|---|
Furst DE et al. Arthritis Rheum 1989;32:584 | Chlorambucil p.o. 0.05-0.1 mg/kg/day versus placebo | 65 SSc | 3 years | NS effect |
O'Dell JR et al. J Rheumatol 1989;32:584 | Total lymphoid irradiation versus untreated control | 6 SSc with internal organ involvement | Follow-up of 1-4 years | NS effect |
Casaes JA et al. Ann Rheum Dis 1990;49:926 | 5-fluorouracil i.v. 4 × 12 mg/kg daily, followed by 4 × 6 mg/kg every two days and maintenance therapy with 12.5 mg/kg weekly versus placebo | 70 SSc (diffuse or limited with visceral involvement) | 6 months | Significant improvement in skin score, Raynaud's score and patient's general assesment scores |
Sharada B et al. Rheumatol Int 1994;14:91 | Dexamethasone i.v. 100 mg/month versus placebo | 35 diffuse SSc | 6 months | Significant improvement in skin score |
Van den Hoogen FH et al. Br J Rheumatol 1996;35:364 | Methotrexate i.m. 15 mg/week versus placebo | 29 SSc with <3 years of skin involvement or with disease progression | 24 weeks | Trend towards improvement in skin score (p = 0.06 in comparison with placebo) |
Clements PJ et al. Arthritis Rheum 2001;44:1351 | D-penicillamine p.o. high (750-1000 mg/d) versus low (125 mg every second day) dose | 134 early diffuse SSc | 2 years | NS effect |
Pope JE et al. Arthritis Rheum 2001;44:1351 | Methotrexate p.o. 15 mg/week versus placebo | 71 early diffuse SSc | 1 year | Improvement in skin scores, borderline significance |
Tashkin DP et al. N Eng J Med 2006;354:2655 | Cyclophosphamide p.o. 1-2 mg/kg/d versus placebo | 154 SSc with early (<7 years duration) SSc, symptomatic SLD and alveolitis | 1 year | Significant improvement in lung volumes, dyspnoea and some measures of health related quality of life. Significant improvement in skin score in diffuse SSc as a secondary outcome measure |
Hoyles Rk et al. Arthritis Rheum 2006;54:3962 | Cyclophosphamide 6 × i.v. 600 mg/m2/month plus oral predonisone 20 mg every second day followed by azathioprine (p.o. 2.5 mg/kg/day) versus placebo | 45 SSc with SLD | 1 year | Trend towards improvement of FVC (p = 0.08), but low power |
Nadashkevich O et al. Clin Rheumatol 2006;25:205 | Cyclophosphamide p.o. 2 mg/kg/d for 12 months, then 1 mg/kg/d for another 6 months versus asathioprine 2.5 mg/kg/d for 12 months and then 2 mg/kg/d for 18 months | 60 early diffuse SSc (<12 months duration) | 18 months | Significant improvement in skin score, lung function tests and frequency of attacks of Raynaud's phenomenon |