Cyclosporine Regimens in Plaque Psoriasis: An Overview with Special Emphasis on Dose, Duration, and Old and New Treatment Approaches

Table 1

Main randomized studies with CsA for induction of remission in plaque-type psoriasis.

Reference	Pts	Baseline PASI	Treatment groups with CsA	Mean PASI improvement from baseline*	Other efficacy results
[9]	133	8–25	(1) 1.25 mg/kg/d; (2) 2.5 mg/kg/d	After 10 wks: (1) 27.2%; (2) 51%	PASI 75 in 63% of pts after other 12 wks with dosage adapted up to 5 mg/kg/d (mean dose: 2.99 mg/kg/d)
[10]	127	≥12	Starting dose: (1) 200 mg (BWI); (2) 2.5 mg/kg/d (BWD). Stepwise dose increase in case of nonresponse up to 300 mg (BWI) or 5 mg/kg/d (BWD)	After 12 wks: (1) 86%; (2) 87%	PASI 75 in 89.4% of total pts (BWI and BWD) after 12 wks
[11]	217	≥15	(1) 1.25 mg/kg/d; (2) 2.5 mg/kg/d.; Dose doubling in case of nonresponse up to 5 mg/kg/d until achievement of response within 12–36 wks	—	Need of dose escalation in 27% of pts in group 2 and 68% in group 1.; PASI 75 response rates within 12–36 wks according to CsA dose: (1) 1.25: 18%; 1.25–2.5: 43%; 1.25–5: 64%; (2) 2.5: 56%; 2.5–5: 72%
[12]	251	≥18	(1) 2.5 mg/kg/d; (2) 5 mg/kg/d	After 12 wks: (1) 69%; (2) 89%	Response (= PASI 75 or PASI < 8) after 12 wks: (1) 52%; (2) 92%
[13]	210	≥18	2.5 mg/kg/d (adjusted up to 5)	After 10 wks: 71.4%	At wk 10, mean dose: 3 mg/kg/d, without a need of dose change in 64% of pts. At 10 wks, PASI 60: 78.8%
[14]	309	≥15	(1) Sandimmun; (2) Neoral.; In both groups, starting dose of 2.5 mg/kg/d with stepwise adjustments (up to 5 mg) according to efficacy or safety	After 16 wks: (1) 76.6%; (2) 79.6%	PASI 75 response rates: at 8 wks: (1) 38.2%; (2) 51.1%; at 16 wks: (1) 80.7%; (2) 87.3%
[7]	85	≥18	(1) 7.5 mg/kg/d; (2) 5 mg/kg/d; (3) 3 mg/kg/d	After 8 wks: (1) 71%; (2) 58%; (3) 39%	Pts clear or almost clear of lesions at 8 wks: (1) 80%; (2) 65%; (3) 36%
[15]	457	≥18	(1) 1.5 mg/kg/d; (2) 2.5–3 mg/kg/d; (3) 5 mg/kg/d	After 12 wks: (1) 35%; (2) 57%; (3) 86%	Response (= PASI 75 or PASI < 8) after 12 wks: (1) 24%; (2) 52%; (3) 88%
[16]	88	≥8	3 mg/kg/d (up to 5 in case of nonresponse)	After 16 wks: 72%	PASI 75 after 16 wks: 71%
[17]	84	No limit	3 mg/kg/d (up to 5 in case of nonresponse)	After 12 wks: 72%;	PASI 75 after 12 wks: 58%

Many of these trials were controlled versus placebo or other active systemic drugs (i.e., etretinate or methotrexate), but the results related to the other treatment groups are omitted.
*Results are distinguished according to the treatment group (see the corresponding number in the related column).
BWD: body weight dependent; BWI: body weight independent; CsA: cyclosporine; d: day; PASI: Psoriasis Area and Severity Index; PASI 60: PASI improvement of at least 60% from baseline; PASI 75: PASI improvement of at least 75% from baseline; pts: patients.