Kim 2018.

Study characteristics
Methods	This study is a randomised, controlled, open‐label trial on mogamulizumab versus vorinostat in patients with histologically‐confirmed diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS).
Participants	The study recruited 372 participants (186 in the mogamulizumab group and 186 in the vorinostat group) with histologically‐proven MF or Sezary Syndrome in stages IB ‐ IVB. Inclusion criteria Males and female participants ≥ 18 years of age at the time of enrolment, except in Japan where participants must be ≥ 20 years of age at the time of enrolment Subjects who have failed at least one prior course of systemic therapy Resolution of all clinically‐significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI‐CTCAE, v.4.0) Participants previously treated with anti‐CD4 antibody or alemtuzumab are eligible provided their CD4+ cell counts are ≥ 200/mm3 Exclusion Criteria Prior treatment with mogamulizumab or vorinostat Large cell transformation. However, participants with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible Clinical evidence of central nervous system (CNS) metastasis
Interventions	Arm I Mogamulizumab 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression Arm II Vorinostat 400 mg once daily
Outcomes	Primary outcome of the trial Progression‐free survival Secondary outcomes of the trial Pruritis evaluation Duration of response (time from first achievement of an overall response to progression or death) Overall response rate Quality of life assessments (Skindex‐29, FACT‐G) Immunogenicity Safety
Notes	Funding was provided by Kyowa Kirin.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Patients were randomised using an interactive voice web response system (IVRS).
Allocation concealment (selection bias)	Low risk	Low risk due to IVRS.
Blinding of participants and personnel (performance bias) All outcomes	High risk	This was an open‐label study, therefore high risk of performance bias.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Low risk due to blinded assessor of outcome data.
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was carried out (analysis 362 of 362): Out of 372 randomised patients, 2 patients did not receive a single treatment, 1 participant was lost to follow‐up.
Selective reporting (reporting bias)	High risk	Initial trial registration contained less secondary outcomes than the final publication. However, several patient‐reported outcomes are missing in this publication, which according to the authors will be published in a secondary article.
Other bias	High risk	Distribution of concomitant topical or systematic steroids not reported, might lead to imbalance between treatment arms and overestimation of treatment effect.