Kimball 2012.

Methods	This was a 3‐arm, parallel group RCT The RCT phase lasted 16 weeks, followed by a 36‐week open label phase
Participants	The trial included 154 participants with a clinical diagnosis of HS Participants were recruited from 26 centres in Denmark, Germany, the Netherlands, and the USA Disease severity was moderate in one third of participants and severe in two thirds of participants The mean weight of the participants was 97.2 kg, and just over half were current smokers
Interventions	3 groups, randomised in a 1:1:1 ratio: s/c placebo ‐ 51 participants, of whom 5 dropped out in the RCT phase s/c adalimumab 40 mg EOW from week 1 to week 15, after an initial dose of 80 mg at week 0 ‐ 52 participants, of whom 0 dropped out in the RCT phase s/c adalimumab 40 mg weekly from week 4 to week 15, after initial doses of 160 mg at week 0 and 80 mg at week 2 ‐ 51 participants, of whom 6 dropped out in the RCT phase
Outcomes	Primary outcome Proportion achieving clinical response at week 16, defined as a HS‐PGA of clear/minimal/mild with at least a 2‐grade improvement from baseline Secondary outcomes HS‐PGA at weeks 2, 4, 8, and 12 Percentage of improvement from baseline in number of inflammatory nodules, abscesses, and draining fistulas at week 16 Change from baseline in modified Sartorius scale score at week 16 Change from baseline in DLQI at week 16 Posthoc analysis of pain VAS. Proportion with a clinically relevant improvement in pain at week 16, defined as at least a 30% reduction from baseline and a 10 mm absolute reduction Change from baseline in TWPI score at week 16 Tolerability of adalimumab in HS, in terms of frequency, type, and severity of adverse events compared with placebo during the 16‐week RCT and 36‐week open label treatment phase
Notes	During the RCT phase, 2 rescue treatments with either an injection of intralesional triamcinolone or incision and drainage were permitted During the 36‐week open label phase, all participants received adalimumab 40 mg EOW. At weeks 28 or 31, any participant with a HS‐PGA score of moderate or worse was eligible to escalate to weekly dosing for the remainder of the study Abbott Laboratories, manufacturers of adalimumab, sponsored the trial
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The random sequence generation was computer generated
Allocation concealment (selection bias)	Low risk	An interactive voice‐response/web‐response system was used
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Identical syringes were used, and all participants received an equal number of injections for each dosing
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Investigators assessed the PGA primary outcome but were blinded to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat analysis was performed
Selective reporting (reporting bias)	Low risk	Primary and secondary outcomes were prospectively declared (NCT00918255)
Other bias	Low risk	We found no other significant bias