Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis

Caitriona Ryan, Jeffrey M Sobell, Craig L Leonardi, Charles W Lynde, Mahinda Karunaratne, Wendell C Valdecantos, Barbara A Hendrickson, Caitriona Ryan, Jeffrey M Sobell, Craig L Leonardi, Charles W Lynde, Mahinda Karunaratne, Wendell C Valdecantos, Barbara A Hendrickson

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.

Conflict of interest statement

Conflict of interest

Caitriona Ryan has acted as an advisor and/or speaker for AbbVie, Aqua, Dermira, Dr. Reddy’s, Janssen, Leo, Lilly, Medimetriks, Novartis, Regeneron-Sanofi, UCB, and Xenoport. Jeffrey M. Sobell has received honoraria and/or research funding from Amgen, AbbVie, Janssen, Celgene, Novartis, Lilly, Lycera, and Merck. Craig L. Leonardi has received funding from AbbVie, Actavis, Amgen, Celgene, Coherus, Dermira, Eli Lilly, Galderma, Janssen, Leo, Merck, Novartis, Pfizer, Sandoz, Stiefel, UCB, and Wyeth. Charles W. Lynde has received funding from AbbVie, Amgen, Boehringer, Celgene, Coherus, Dermira, Eli Lilly, Galderma, Innovaderm, Janssen, Leo Pharma, Merck, MSD, MedImmune, Novartis, Pfizer, Regeneron, and Xoma and reimbursement of traveling, accommodation, and hospitality expenses from AbbVie, Amgen, Boehringer, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, MSD, Novartis, Pfizer, and Valeant. Wendell C. Valdecantos and Barbara A. Hendrickson are employees of AbbVie, Inc. and may own AbbVie stock and/or stock options. Mahinda Karunaratne was an employee of AbbVie, Inc. at the time of this research and may own AbbVie stock and/or stock options.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all participants in the individual studies included in these analyses.

Figures

Fig. 1
Fig. 1
Study designs of a the hidradenitis suppurativa phase III, PIONEER I and II studies, b the psoriasis phase II, double-blind, placebo-controlled study, and c the psoriasis open-label study. EOW every other week, EW every week, PASI Psoriasis Area and Severity Index, PASI50 ≥ 50% improvement in PASI, PASI75 ≥ 75% improvement in PASI. aStarting at week 4 following 160 mg at week 0 and 80 mg at week 2. bPatients receiving adalimumab 40 mg EW, initially received adalimumab 80 mg at weeks 0 and 1 and then 40 mg weekly starting at week 2; patients receiving adalimumab 40 mg EOW, initially received adalimumab 80 mg at week 0 (week 13 for those randomized to placebo) and then 40 mg EOW starting 1 week later. cOne patient was randomized but withdrew consent and did not receive treatment. dIf < PASI50 (relative to baseline of original study start) at any time from week 24 on. eIf ≥ PASI75 (relative to baseline of original study start) at any time after dose escalation. fIf < PASI50 (relative to baseline of original study start) at any time after de-escalating, after which patients remained on adalimumab 40 mg EW

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Source: PubMed

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