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

Krueger 2016a.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind
Date of study: March 2013 ‐ November 2013
Location: 6 centres in the USA
Participants Randomised: 12 participants (mean age 45.5 years, 8 male)
Inclusion criteria
  • Participants with moderate‐severe psoriasis (PASI ≥ 12 or BSA ≥ 10), age ≥ 18 years


Exclusion criteria
  • Pregnancy, immunosuppression, kidney insufficiency, liver insufficiency, past history of malignant tumours, active infection, uncontrolled cardiovascular disorder, uncontrolled diabetes, uncontrolled hypertension


Dropouts and withdrawals
  • 1/12 (1%);

  • Lost to follow‐up: tofacitinib (1)

Interventions Intervention
A. Tofacitinib (n = 9), orally, 10 mg twice daily
Control intervention
B. Placebo (n = 3)
Outcomes Assessments at 12 weeks
Primary outcomes of the trial
  • PGA 0‐1

  • PASI 75


Secondary outcomes of the trial
  • AEs

Notes Funding source:
Quote (p 1079): “This study was sponsored by Pfizer Inc. Both Pfizer Inc and non‐Pfizer Inc authors have participated in the study design, data collection, data analysis, and open scientific discussion of the data; its interpretation; and the development of the associated manuscript. The views and opinions expressed within the manuscript are those of all authors and do not necessarily represent those of the funding organization. Medical writing support was funded by Pfizer Inc.”.
Declarations of interest (p 1079) : "J. Krueger received research funding from Novartis, Pfizer Inc, Janssen, Lilly, Merck, Kadmon, Dermira, Boehringer, BMS, and Paraxel during the conduct of the study; grants paid to institutions from Amgen, Innovaderm and Kyowa; and personal fees from Serono, BiogenIdec, Delenex, AbbVie, Sanofi, Baxter, Xenoport, and Kineta. M. Suárez‐Fariñas receives research funding and speakers' fees from Pfizer. J. D. Clark, H. Tan, R. Wolk, S. T. Rottinghaus, M. Z. Whitley, H. Valdez, D. von Schack, S. P. O'Neil, P. S. Reddy, and S. Tatulych are employees of Pfizer Inc. The rest of the authors declare that they have no relevant conflicts of interest."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote (p 1079): “Patients were randomised 3:1 to receive 10 mg of oral tofacitinib or placebo twice daily for 12 weeks by using an automated Web or telephone randomization system”
Comment: probably done
Allocation concealment (selection bias) Low risk Quote (p 1079): “Patients were randomised 3:1 to receive 10 mg of oral tofacitinib or placebo twice daily for 12 weeks by using an automated Web or telephone randomisation system”
Comment: probably done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote (p 1079): “This was a phase 2, randomised, placebo‐controlled, double‐blind study carried out in 6 centers”
Comment: placebo‐controlled, probably done
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote (p 1079): “This was a phase 2, randomised, placebo‐controlled, double‐blind study carried out in 6 centers”
Comment: placebo‐controlled, probably done
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Randomly assigned 12, analysed 11
Management of missing data: not mentioned
Selective reporting (reporting bias) Low risk Comment: the protocol for the study was available on ClinicalTrials.gov (NCT01710046)
The prespecified outcomes in the protocol or those mentioned in the Methods section have been reported in the Results section