Elewski 2016.

Study characteristics
Methods	Randomised, placebo‐controlled, double‐blind trial date: January 2014 to April 2016 Location: worldwide
Participants	Total sample size: 217 Inclusion criteria Adults with clinical diagnosis of chronic plaque psoriasis (with a disease duration of ≥ 6 months) and ≥ 1 fingernail with nail psoriasis BSA ≥ 10% and a target fingernail mNAPSI ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail NAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0 Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain score of > 3 PGA of fingernail psoriasis and a PGA of skin psoriasis of ≥ moderate Must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for ≥ 4 weeks prior to Week 0, ustekinumab must have been discontinued ≥ 12 weeks prior to Week 0 Target fingernail must have mNAPSI score of ≥ 8 Exclusion Criteria Prior adalimumab therapy Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis Recent infection requiring treatment Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse Women who are pregnant or breast‐feeding or considering becoming pregnant during the study History of cancer, except successfully treated skin cancer Dropouts and withdrawals 29/217 (13.3%); Adalimumab group (15), placebo group (14) Protocol violation: Adalimumab group (0), placebo group (1) Lack of efficacy: Adalimumab group (1), placebo group (2) AEs: Adalimumab group (5), placebo group (3) Withdrawal by participant: Adalimumab group (4), placebo group (3) Lost to follow‐up: Adalimumab group (3), placebo group (3) Others: Adalimumab group (3), placebo group (1)
Interventions	Intervention A. Adalimumab, SC, 40 mg, eow for 25 weeks starting 1 week after initial loading dose of 80 mg, n = 109 Control intervention B. Placebo, n = 108
Outcomes	At week 12 mNAPSI 75, PGA of fingernails of clear or minimal PASI 75/90/100 for participants with baseline PASI at 5
Notes	Funding source: Quote (p 90): "AbbVie funded this study and participated in the study design; study research; collection, analysis and interpretation of data; and writing, review, and approval of this article. All authors had access to the data and participated in the development, review, and approval of this article and in the decision to submit it for publication." Conflict of interest Quote (p 90): "Dr Elewski has received research funding (paid to her institution) from AbbVie, Amgen, Boehinger Ingelheim, Celgene, Incyte, Lilly, Merck, Novan, Novartis, Pfizer, Valeant, and Viament and honoraria for serving as a consultant to Anacor, Celgene, Lilly, Novartis, Pfizer, and Valeant. Dr Okun has received honoraria for serving on an advisory board and/or as a speaker for AbbVie, Crescendo Biosciences, Gilead Science, and UCB, and he is a former AbbVie employee. Dr Papp has received honoraria for serving on an advisory board or panel, serving as a consultant and speaker for and has received grants (as an investigator) from Allergan, Amgen, Celgene, Centocor, Eli Lilly, Galderma, Genentech, Janssen, LEO Pharma, Merck, Merck‐Serono, Novartis, Pfizer, Schering Plough, and Wyeth. In addition, Dr Papp has received honoraria (as a consultant) and grants (as an investigator) from Astellas, Apotex, Baxter, Boehringer Ingelheim, Kyowa Kirin, Regeneron, and UCB; received honoraria (for serving on an advisory board and panel) from AbbVie, Apotex, Baxter, Boehringer Ingelheim, and UCB; received honoraria (as a consultant) from AbbVie and Bristol‐Myers Squibb; received honoraria (as a speaker) from AbbVie, Astellas, and Janssen‐Cilag; and received grants (as an investigator) from Bristol‐Myers Squibb and GlaxoSmithKline Beecham. Mr Baker has received honoraria (for serving on an advisory board and panel) from Abbvie, Pfizer, Novartis, and Celgene. Dr Crowley has received honoraria (as a consultant and speaker) from AbbVie, Amgen, Celgene, Lilly, and Novartis and has received grants (as an investigator) from AbbVie, Amgen, Astra‐Zeneca, Boehringer Ingelheim, Celgene, Janssen, Lilly, Maruho, Merck, Novartis, Pfizer, Regeneron, and Sandoz. Dr Guillet has received grants (as an investigator) from AbbVie. Dr Sudaram is a former AbbVie employee. Dr Poulin has received grants (as an investigator) and honoraria (as a speaker and for serving on advisory boards) from AbbVie, Amgen, and Centocor/Janssen‐Ortho and has received grants (as an investigator) from Aquinox, Baxter, Boehringer Ingelheim, Bristol‐Myers‐Squibb, Celgene, DS Biopharma, Eli Lilly, Galderma, Genentech, GlaxoSmithKline Beecham, LEO Pharma, Medimmune, Merck, Novartis, Pfizer, Regeneron, Schering Plough, Serono, Takeda, and UCB Pharma. Ms Gu, Dr Geng, and Dr Williams are salaried employees of AbbVie and they receive stocks and stock options. Dr Rich has received honoraria (for serving on an advisory board) from AbbVie, Eli Lilly, Novartis, Sandoz, and Valeant; honoraria (as a consultant) from AbbVie, Novartis, Polichem, and Valeant; and grants (as an investigator) from AbbVie, Allergan, Amgen, Anacor, Cassiopea, Dusa, Eli Lilly, Galderma, Janssen, Leo, Meiji, Merck, Neothetics, Novartis, Pfizer, Psolar, Sandoz, Ranbaxy, and Viamet.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote (pp 91‐2): "This was a phase 3, multicenter, double‐blind, randomized, parallel‐arm, placebo‐controlled trial...Randomization was determined by an interactive voice/web response system." Comment: probably done
Allocation concealment (selection bias)	Low risk	Quote (pp 91‐2): "This was a phase 3, multicenter, double‐blind, randomized, parallel‐arm, placebo‐controlled trial...Randomization was determined by an interactive voice/web response system." Comment: probably done
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote (pp 91‐2): "This was a phase 3, multicenter, double‐blind, randomized, parallel‐arm, placebo‐controlled trial...The investigator, study site, and patients remained blinded to treatment." Comment: probably done
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote (pp 91‐2): "This was a phase 3, multicenter, double‐blind, randomized, parallel‐arm, placebo‐controlled trial...The investigator, study site, and patients remained blinded to treatment." Comment: probably done
Incomplete outcome data (attrition bias) All outcomes	Low risk	Randomly assigned 217 Management of missing data: Quote (p 90): "The primary efficacy analysis was performed for the period A intent‐to‐treat population. The primary analysis and ranked secondary end points were tested in ranked order to control multiplicity, and missing data were handled by multiple imputation for all end points." Table 2: 217 analysed participants Comment: done
Selective reporting (reporting bias)	Low risk	Comment: the protocol for the study was available on ClinicalTrials.gov (NCT02016482) The prespecified outcomes and those mentioned in the Methods section appeared to have been reported Results posted on ClinicalTrials.gov