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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Jin 2017.

Study characteristics
Methods RCT, placebo‐controlled trial
Date of study: not stated
Location: China (number of centres not specified
Participants Randomised: 18 participants (age median 48 years, 11 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis

  • Authors' assessment > 6 months, PASI ≥ 12, BSA > 10%

  • Age > 18 years

  • Candidates for systemic therapy or phototherapy for psoriasis


Exclusion criteria
  • Non‐plaque or drug‐induced psoriasis, or other skin conditions that would interfere with psoriasis evaluation

  • Inability to discontinue current systemic therapy (for at least 4 weeks), topical therapy,or phototherapy (for at least 2 weeks); concomitant oral or injection of corticosteroids; and previous treatment with efalizumab or having participated in studies involving oral tofacitinib

  • Patients were also excluded from the study if they were pregnant or had immune‐deficient diseases or severe systemic disorders


Dropouts and withdrawals
  • No statement

Interventions Intervention
A. Tofacitinib (n = 7), orally 10 mg, twice a day, 16 weeks
Control intervention
B. Tofacitinib (n = 5), orally, 5 mg, twice a day, 16 weeks
C. Placebo (n = 6)
Outcomes Assessments at 16 weeks
Outcomes of the trial (not primary ou secondary outcomes)
  • PASI 75

  • Serum hBD‐2 concentration

Notes Funding source: Not stated
Declarations of interest (p 169): "The authors have no conflict of interest to declare"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (supplemental appendix) "The patients were randomized to receive placebo or tofacitinib 5or 10mg twice daily (b.i.d.) for 16 weeks"
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Comment: no description of the method used to guarantee random allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote (supplemental appendix) "The patients were randomized to receive placebo or tofacitinib 5or 10mg twice daily (b.i.d.) for 16 weeks"
Comment: no more description than using a placebo
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote (supplemental appendix) "The patients were randomized to receive placebo or tofacitinib 5or 10mg twice daily (b.i.d.) for 16 weeks"
Comment: no more description than using a placebo
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Quote (supplemental appendix): "All analyses were intention to treat."
No statement on number of missing data and how authors dealt with it
Selective reporting (reporting bias) Low risk Comment: no protocol for the study available on ClinicalTrials.gov
The prespecified outcomes and those mentioned in the Methods section appeared to have been reported