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.

Abstract

Background: Adalimumab is approved for the treatment of hidradenitis suppurativa (HS), plaque psoriasis, and other inflammatory conditions.

Objective: Our objective was to examine the safety of adalimumab administered every other week (EOW) and every week (EW) in patients with HS and psoriasis and to investigate informative data from non-dermatologic indications.

Methods: The safety of adalimumab 40-mg EOW versus EW dosing was examined during placebo-controlled and open-label study periods in patients with HS (three studies), psoriasis (two studies), Crohn's disease (six studies), ulcerative colitis (three studies), and rheumatoid arthritis (one study).

Results: No new safety risks or increased rates of particular adverse events (AEs) were identified with EW dosing. In patients with HS or psoriasis, the overall safety of adalimumab 40-mg EOW and EW was generally comparable. In studies of adalimumab for non-dermatologic indications, including Crohn's disease, ulcerative colitis, and rheumatoid arthritis, the overall AE rates were similar for EW and EOW dosing.

Conclusion: In patients with HS or psoriasis, the safety of adalimumab EW and EOW was comparable and consistent with the expected adalimumab AE profile. The safety of adalimumab EW dosing in patients with dermatologic conditions is supported by data comparing adalimumab EW and EOW dosing for Crohn's disease, ulcerative colitis, and rheumatoid arthritis.

Trial registration: ClinicalTrials.gov NCT00918255, NCT01468207, NCT01468233, NCT00645814, NCT00077779, NCT00055497, NCT01070303, NCT00195715, NCT00348283, NCT00385736, NCT00408629, and NCT00573794.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Adalimumab / administration & dosage
  • Adalimumab / therapeutic use*
  • Adult
  • Anti-Inflammatory Agents / administration & dosage
  • Anti-Inflammatory Agents / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Hidradenitis Suppurativa / drug therapy*
  • Humans
  • Injections, Subcutaneous
  • Male
  • Placebos
  • Psoriasis / drug therapy*
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Young Adult

Substances

  • Anti-Inflammatory Agents
  • Placebos
  • Tumor Necrosis Factor-alpha
  • Adalimumab

Associated data

  • ClinicalTrials.gov/NCT00055497
  • ClinicalTrials.gov/NCT01468207
  • ClinicalTrials.gov/NCT01468233
  • ClinicalTrials.gov/NCT00077779
  • ClinicalTrials.gov/NCT00408629
  • ClinicalTrials.gov/NCT01070303
  • ClinicalTrials.gov/NCT00645814
  • ClinicalTrials.gov/NCT00573794
  • ClinicalTrials.gov/NCT00348283
  • ClinicalTrials.gov/NCT00918255
  • ClinicalTrials.gov/NCT00385736
  • ClinicalTrials.gov/NCT00195715