Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsCiclosporinPlaceboRelative (95% CI)Absolute
PASI 75 – CSA 5 mg/kg/day at weekends only (follow-up 24 weeks)
1
Colombo 2010
randomised trialsvery seriousano serious inconsistencyno serious indirectnessseriousbnone85/127 (66.9%)33/62 (53.2%)RR 1.26 (0.97 to 1.64)138 more per 1000 (from 16 fewer to 341 more)⊕○○○
VERY LOW
Mean final PASI – CSA 5 mg/kg/day at weekends only (follow-up 24 weeks; better indicated by lower values)
1
Colombo 2010
randomised trialsvery seriousano serious inconsistencyseriouscno serious imprecisionnone12762-MD 1.5 lower (4.14 lower to 1.14 higher)⊕○○○
VERY LOW
Maintaining at least mild psoriasis following PASI75 – CSA three-times weekly (follow-up 12 weeks)
1
Thaci 2002
randomised trialsseriousdno serious inconsistencyno serious indirectnessseriousbnone14/31 (45.2%)5/22 (22.7%)RR 1.99 (0.84 to 4.71)225 more per 1000 (from 36 fewer to 843 more)⊕⊕○○
LOW
Time-to-relapse – CSA three-times weekly (follow-up 12 weeks)
1
Thaci 2002
randomised trialsseriousdno serious inconsistencyno serious indirectnessno serious imprecisionnone17/42 (40.5%)29/51 (56.9%)HR 0.45 (0.24 to 0.82)254 fewer per 1000 (from 70 fewer to 386 fewer)⊕⊕⊕○
MODERATE
Time-to-relapse – CSA 3 mg/kg/day (follow-up 24 weeks)
1
Shupack 1997
randomised trialsseriousdno serious inconsistencyno serious indirectnessno serious imprecisionMedian time

CSA 3mg/kg/day: >24 weeks

Placebo or CSA 1.5mg/kg/day: 6 weeks
35/83 (42.2%)40/48 (83.3%)HR 0.30 (0.19 to 0.49)418 fewer per 1000 (from 249 fewer to 545 fewer)⊕⊕⊕○
MODERATE
Mean time to relapse (weeks) - CSA 1.5 mg/kg/day (follow-up up to 4 months; better indicated by higher values)
1
Ellis 1995
randomised trialsseriousano serious inconsistencyno serious indirectnessseriousbnone2020-MD 2 higher (0.77 lower to 4.77 higher)⊕⊕○○
LOW
Relapse rate - CSA 1.5 mg/kg/day (follow-up up to 4 months)
1
Ellis 1995
randomised trialsseriousano serious inconsistencyseriouseseriousbnone14/20 (70%)18/20 (90%)RR 0.78 (0.56 to 1.07)198 fewer per 1000 (from 396 fewer to 63 more)⊕○○○
VERY LOW
Mean time to relapse (weeks) - CSA 3 mg/kg/day (follow-up up to 4 months; better indicated by higher values)
1
Ellis 1995
randomised trialsseriousano serious inconsistencyno serious indirectnessno serious imprecisionnone2120-MD 5 higher (2.23 to 7.77 higher)⊕⊕⊕○
MODERATE
Relapse rate - CSA 3 mg/kg/day (follow-up up to 4 months)
1
Ellis 1995
randomised trialsseriousano serious inconsistencyseriouseno serious imprecisionnone8/21 (38.1%)18/20 (90%)RR 0.42 (0.24 to 0.74)522 fewer per 1000 (from 234 fewer to 684 fewer)⊕⊕○○
LOW
Relapse rate – CSA 5 mg/kg/day at weekends only (follow-up up to 24 weeks)
1
Colombo 2010
randomised trialsvery seriousano serious inconsistencyno serious indirectnessseriousbnone42/127 (33.1%)29/62 (46.8%)RR 0.71 (0.49 to 1.02)136 fewer per 1000 (from 239 fewer to 9 more)⊕○○○
VERY LOW
Withdrawal due to toxicity – CSA 5 mg/kg/day at weekends only (follow-up 24 weeks)
1
Colombo 2010
randomised trialsvery seriousfno serious inconsistencyno serious indirectnessvery seriousgnone8/160 (5%)2/79 (2.5%)RR 1.98 (0.43 to 9.08)25 more per 1000 (from 14 fewer to 205 more)⊕○○○
VERY LOW
Severe adverse events – CSA 5 mg/kg/day at weekends only (follow-up 24 weeks)
1
Colombo 2010
randomised trialsvery seriousano serious inconsistencyno serious indirectnessvery seriousgnone1/160 (0.6%)0/79 (0%)RR 1.49 (0.06 to 36.18)-⊕○○○
VERY LOW
Elevated serum creatinine – CSA 5 mg/kg/day at weekends only (follow-up 24 weeks)
1
Colombo 2010
randomised trialsvery seriousano serious inconsistencyno serious indirectnessvery seriousgnone8/160 (5%)3/79 (3.8%)RR 1.32 (0.36 to 4.83)12 more per 1000 (from 24 fewer to 145 more)⊕○○○
VERY LOW
Elevated serum creatinine – CSA three-times weekly (at 2 consecutive visits) (follow-up 12 weeks)
1
Thaci 2002
randomised trialsseriousdno serious inconsistencyno serious indirectnessno serious imprecisionnone0/42 (0%)0/51 (0%)not poolednot pooled⊕⊕⊕○
MODERATE
Change in PASI – CSA three-times weekly (follow-up 12 weeks; better indicated by lower values)
1
Thaci 2002
randomised trialsseriousdno serious inconsistencyno serious indirectnessserioushnone4251-Mean PASI increase
CSA: 2.7 to 9.9
Placebo: 3.0 to 11.9
⊕⊕○○
LOW
Median time to relapse – CSA three-times weekly (follow-up 12 weeks; better indicated by higher values)
1
Thaci 2002
randomised trialsseriousdno serious inconsistencyno serious indirectnessseriousinone4251-CSA: 98 days
Placebo: 69 days
⊕⊕○○
LOW
Time to relapse – CSA 5 mg/kg/day at weekends only (follow-up 24 weeks; better indicated by higher values)
1
Colombo 2010
randomised trialsvery seriousano serious inconsistencyseriousjseriousnone16079p = 0.0233 (favours CSA)-⊕○○○
VERY LOW
a

Unclear method of randomisation and unclear allocation concealment and high dropout rate (30% - figures reported were per protocol)

b

Confidence interval ranges from clinically important effect to no effect

c

Surrogate measure for change in PASI

d

Unclear allocation concealment

e

Surrogate for time to relapse

f

Unclear method of randomisation and unclear allocation concealment and high dropout rate (30%)

g

Confidence interval crosses the boundary for clinical significance in favour of both treatment, as well as line of no effect

h

No range or SD around change scores

i

No range stated

j

Only p-value provided

From: 10, Systemic non-biological therapy

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Psoriasis: Assessment and Management of Psoriasis.
NICE Clinical Guidelines, No. 153.
National Clinical Guideline Centre (UK).
Copyright © National Clinical Guideline Centre - October 2012.

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