PMID- 29380251 OWN - NLM STAT- MEDLINE DCOM- 20181001 LR - 20181113 IS - 1179-1888 (Electronic) IS - 1175-0561 (Print) IS - 1175-0561 (Linking) VI - 19 IP - 3 DP - 2018 Jun TI - Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. PG - 437-447 LID - 10.1007/s40257-017-0341-6 [doi] AB - 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. FAU - Ryan, Caitriona AU - Ryan C AD - Department of Dermatology, Blackrock Clinic, Co. Dublin, Ireland. caitrionaryan80@gmail.com. FAU - Sobell, Jeffrey M AU - Sobell JM AD - Department of Dermatology, Tufts University School of Medicine, Boston, MA, USA. FAU - Leonardi, Craig L AU - Leonardi CL AD - Department of Dermatology, St. Louis University, St. Louis, MO, USA. FAU - Lynde, Charles W AU - Lynde CW AD - Department of Medicine, University of Toronto, Toronto, ON, Canada. FAU - Karunaratne, Mahinda AU - Karunaratne M AD - AbbVie Inc., North Chicago, IL, USA. FAU - Valdecantos, Wendell C AU - Valdecantos WC AD - AbbVie Inc., North Chicago, IL, USA. FAU - Hendrickson, Barbara A AU - Hendrickson BA AD - AbbVie Inc., North Chicago, IL, USA. LA - eng SI - ClinicalTrials.gov/NCT00055497 SI - ClinicalTrials.gov/NCT01468207 SI - ClinicalTrials.gov/NCT01468233 SI - ClinicalTrials.gov/NCT00077779 SI - ClinicalTrials.gov/NCT00408629 SI - ClinicalTrials.gov/NCT01070303 SI - ClinicalTrials.gov/NCT00645814 SI - ClinicalTrials.gov/NCT00573794 SI - ClinicalTrials.gov/NCT00348283 SI - ClinicalTrials.gov/NCT00918255 SI - ClinicalTrials.gov/NCT00385736 SI - ClinicalTrials.gov/NCT00195715 PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial PL - New Zealand TA - Am J Clin Dermatol JT - American journal of clinical dermatology JID - 100895290 RN - 0 (Anti-Inflammatory Agents) RN - 0 (Placebos) RN - 0 (Tumor Necrosis Factor-alpha) RN - FYS6T7F842 (Adalimumab) SB - IM MH - Adalimumab/administration & dosage/*therapeutic use MH - Adult MH - Anti-Inflammatory Agents/administration & dosage/*therapeutic use MH - Double-Blind Method MH - Drug Administration Schedule MH - Female MH - Hidradenitis Suppurativa/*drug therapy MH - Humans MH - Injections, Subcutaneous MH - Male MH - Placebos MH - Psoriasis/*drug therapy MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/antagonists & inhibitors MH - Young Adult PMC - PMC5945711 COIS- 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. EDAT- 2018/01/31 06:00 MHDA- 2018/10/03 06:00 PMCR- 2018/01/27 CRDT- 2018/01/31 06:00 PHST- 2018/01/31 06:00 [pubmed] PHST- 2018/10/03 06:00 [medline] PHST- 2018/01/31 06:00 [entrez] PHST- 2018/01/27 00:00 [pmc-release] AID - 10.1007/s40257-017-0341-6 [pii] AID - 341 [pii] AID - 10.1007/s40257-017-0341-6 [doi] PST - ppublish SO - Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.