Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
Summary
A study to evaluate the safety and efficacy of treatment with adalimumab in adults with moderate to severe hidradenitis suppurativa (HS).
Timeline
- Start
- 2011-11
- Primary completion
- 2014-01
- Completion
- 2014-01
Outcome
Met primary endpoint
paper Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: PMID 27518661 ↗
paper 41.8% versus 26.0% in PIONEER I (P=0.003) PMID 27518661 ↗
registry analysis (unspecified test); Placebo vs Adalimumab Every Week (EW); p =0.003; Adjusted mean difference 15.9 (95% CI 5.3 to 26.5) NCT01468207 ↗
release “PIONEER I study show that moderate-to-severe HS patients treated with HUMIRA 40 mg weekly achieved a significantly greater response versus those on placebo” abbvie.com ↗
release “moderate-to-severe HS patients treated with HUMIRA 40 mg weekly achieved a significantly greater response versus those on placebo at week 12 (41.8% versus 26%,” abbvie.com ↗
Publications
- Results Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, Armstrong AW, Kerdel F, Gold MH, Forman SB, Korman NJ, Giamarellos-Bourboulis EJ, Crowley JJ, Lynde C, Reguiai Z, Prens EP, Alwawi E, Mostafa NM, Pinsky B, Sundaram M, Gu Y, Carlson DM, Jemec GB. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370.
- Kearney N, Chen X, Bi Y, Hew K, Smith KM, Kirby B. Treatment of hidradenitis suppurativa with adalimumab in the PIONEER I and II randomized controlled trials reduced indices of systemic inflammation, recognized risk factors for cardiovascular disease. Clin Exp Dermatol. 2025 Jan 27;50(2):339-347. doi: 10.1093/ced/llae324.
- Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |