Mrowietz 2019.

Methods	Randomised, controlled, parallel‐arm study 61 centres in Europe Period of inclusion: December 26, 2013 to January 20, 2016
Participants	Inclusion criteria Palmoplantar pustular psoriasis for at least 6 months before randomisation Moderate to severe palmoplantar pustular psoriasis as defined at baseline by PPPASI score ≥ 12 and DLQI ≥ 10 Candidate for systemic therapy, defined as having palmoplantar pustular psoriasis inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy Exclusion criteria Forms of psoriasis other than chronic plaque psoriasis and pustular palmoplantar psoriasis (e.g. erythrodermic, guttate, or generalised pustular psoriasis) Drug‐induced psoriasis (e.g. new‐onset or current exacerbation from beta‐blockers, calcium channel inhibitors, or lithium) or history of proven contact dermatitis Not willing to limit UV light exposure (e.g. sunbathing, use of tanning devices) during the course of the study Ongoing use of prohibited psoriasis treatments (e.g. topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to Previous exposure to any biologic drug directly targeting IL‐17 or IL‐17 receptor (e.g. secukinumab, ixekizumab, brodalumab) Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment and for 16 weeks after stopping treatment Active ongoing inflammatory disease other than psoriasis that might confound evaluation of the benefit of secukinumab therapy Use of any other investigational drugs within 4 weeks of study drug initiation or within a period of 5 half‐lives of investigational treatment, whichever is longer Baseline data: secukinumab 300 mg (n = 79)/secukinumab 150 mg (n = 80)/placebo (n = 78) Mean age, years: 50.6/50.7/52.9 Female, n (%): 64 (81.0)/63 (78.8)/59 (75.6) Mean duration of disease, years: 8.0/9.5/10.3 Proportion of participants with psoriatic lesions elsewhere, n (%): 34 (43.0)/38 (47.5)/36 (46.2) Mean baseline PPPASI: 23.0/23.1/23.6 Withdrawal: 15 (withdrawal by participant 7, AE 8)/15 (withdrawal by participant 7, AE 6, pregnancy 1, physician decision 1)/12 (withdrawal by participant 5, AE 6, physician decision 1)
Interventions	Intervention 1 Secukinumab, 300 mg subcutaneously at baseline; weeks 1, 2, 3, and 4 Intervention 2 Secukinumab, 150 mg, subcutaneously at baseline; weeks 1, 2, 3, and 4 Intervention 3 Placebo subcutaneously at baseline; weeks 1, 2, 3, and 4 Duration of treatment: 4 weeks for period 1
Outcomes	Primary outcome Percentage of participants with PPPASI 75 response at week 16 assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (PPPASI 75) Secondary outcomes PPPASI: absolute change from baseline to week 16 Percentage of participants with PPPASI 75 response week 16 Percentage of participants with most frequent adverse events week 16 Patient‐reported outcomes: DLQI 25, Palmar‐Pustular Quality of Life Index, Work Productivity and Activity Impairment Questionnaire‐Psoriasis (WPAI‐PSO)
Notes	Novartis sponsored the 2PRECISE study and provided funding for conduct of the study, data analysis, and medical writing assistance for the study’s publication
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was carried out by using interactive response technology" Comment: randomisation method was described
Allocation concealment (selection bias)	Unclear risk	Comment: no indication of measure undertaken to guarantee allocation concealment
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "double‐blind" Comment: pre‐filled syringe, placebo‐controlled probably adequate
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double‐blind" Comment: pre‐filled syringe, placebo‐controlled probably adequate
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Efficacy analyses were based on the full analysis set, comprising all subjects to whom study treatment was assigned. Subjects with missing PPPASI assessments at week 16 were considered responders if they met the response criteria by the time of dropout; otherwise, they were considered nonresponder (last observation carried forward)" Comment: all included participants were analysed
Selective reporting (reporting bias)	Low risk	Comment: all outcomes pre‐specified in registration file were reported