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. 2015 Oct 7;2015(10):CD010081. doi: 10.1002/14651858.CD010081.pub2

Miller 2011.

Methods This was a 2‐arm, parallel group RCT
The RCT phase lasted 12 weeks, followed by a 12‐week observational follow‐up phase with no treatment
Participants The trial included 21 participants with moderate to severe HS, defined as Hurley stage II or III, for at least 6 months
Interventions 2 groups randomised in a 1:2 ratio (placebo:active):
  • s/c placebo ‐ 6 participants, of whom 1 dropped out during the RCT phase

  • s/c adalimumab, initial dose 80 mg, then 40 mg every other week for 12 weeks ‐ 15 participants, of whom 1 dropped out during the RCT phase

Outcomes Primary outcomes
  1. Unmodified Sartorius severity scale score at week 12 (week 24 used to assess recurrence)

  2. Hurley score at week 12 (week 24 for recurrence)


Secondary outcomes
  1. Pain VAS score at week 12 (week 24 for recurrence)

  2. Number of self‐reported days with lesions between visits

  3. DLQI at week 12 (week 24 for recurrence)

  4. Manchester (postinflammatory) Scar Score at week 24

  5. Physician Global Assessment scar score at week 24

Notes The study did not reach its recruitment target of 30 participants because the study medication exceeded its expiry date
Abbott, manufacturers of adalimumab, provided the active drug, placebo, and computer randomisation. No salary was paid to the investigators or to the department performing the study
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) Unclear risk Sequentially numbered containers were used, but the paper did not specify if the containers were opaque
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Identical syringes were used as well as the same dosing schedule. The adverse effects were unlikely to have caused unblinding
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Treating clinicians assessed the outcomes but were unlikely to be unblinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk The trial undertook ITT analysis with LOCF and first observation carried backwards. The authors stated: "The combination of last observation carried forward and first observation carried backward ensures that for a given patient both missing values after the last observation as well as missing values prior to the first observation are imputed"
Selective reporting (reporting bias) Unclear risk EudraCT: 2006‐005297‐48, but a search for the study was unsuccessful
Other bias High risk Baseline disease severity was higher in the adalimumab group