Subcutaneous adalimumab (Humira®) is a tumour necrosis factor-α blocker that is 
the only approved agent for the treatment of moderate to severe hidradenitis 
suppurativa (HS) in several countries worldwide. This article reviews the 
clinical efficacy and safety of subcutaneous adalimumab in patients with 
moderate to severe HS. In clinical trials (PIONEER I and II), a greater 
proportion of adalimumab than placebo recipients reached HS clinical response 
(HiSCR) at week 12. The main secondary endpoints, such as the proportion of 
patients with an abscess and inflammatory nodule count of ≤2 at week 12, were 
significantly greater with adalimumab than with placebo in PIONEER II, but not 
in PIONEER I. In addition, adalimumab showed the potential to reduce the high 
health-related quality of life burden of HS and increase patient satisfaction. 
HiSCR rates were generally maintained in the longer term, and the safety profile 
of adalimumab in patients with moderate to severe HS was consistent with the 
known safety profile of the drug for other indications, with no new emerging 
safety signals. Adalimumab is an effective and generally well tolerated 
treatment for patients with moderate to severe HS, and is the first agent 
approved for this difficult-to-treat disease.