Alexa B. Kimball, MD, MPH; Francisco Kerdel, MD; David Adams, MD, PharmD; Ulrich Mrowietz, MD; Joel M. Gelfand, MD, MSCE; Robert Gniadecki, MD; Errol P. Prens, MD, PhD; Joel Schlessinger, MD; Christos C. Zouboulis, MD, PhD; Hessel H. van der Zee, MD, PhD; Marie Rosenfeld, BA; Parvez Mulani, PhD; Yihua Gu, MS; Susan Paulson, PhD; Martin Okun, MD, PhD; Gregor B.E. Jemec, MD, DMSc
Disclaimer: All authors had unrestricted access to printouts of the data and to the analyses, were involved in the writing and review of the manuscript and the decision to submit it for publication, and vouch for the accuracy and completeness of the data analyses and results presented.
Acknowledgment: The authors thank Amy Gamelli, PhD, of Abbott Laboratories, for providing medical writing support during the development and writing of this manuscript; Ke Chen, formerly of Abbott Laboratories, for her support in statistical analysis; and Thomas Harris, RPh, formerly of Abbott Laboratories, for his scientific contributions to the development of the study protocol.
Financial Support: By Abbott Laboratories.
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-2529.
Reproducible Research Statement: Study protocol and data set: Not available. Statistical code: Available from Dr. Okun (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Alexa B. Kimball, MD, MPH, Clinical Unit for Research Trials and Outcomes in Skin, Massachusetts General Hospital, Harvard Medical School, 50 Staniford Street, No. 246, Boston, MA 02114; e-mail, email@example.com.
Current Author Addresses: Dr. Kimball: Clinical Unit for Research Trials and Outcomes in Skin, Massachusetts General Hospital, Harvard Medical School, 50 Staniford Street, No. 246, Boston, MA 02114.
Dr. Kerdel: Florida Academic Dermatology Centers, 1400 NW 12 Avenue, Suite 4, Miami, FL 33136.
Dr. Adams: Penn State Milton S. Hershey Medical Center, Department of Dermatology, 500 University Drive, Hershey, PA 17033.
Dr. Mrowietz: Department of Dermatology, University Medical Center Schleswig-Holstein, Schittenhelmstraße 7, 24105 Kiel, Germany.
Dr. Gelfand: University of Pennsylvania, 1471 Penn Tower, 1 Convention Avenue, Philadelphia, PA 19104.
Dr. Gniadecki: Bispebjerg Hospital, Department of Dermatology, Bispebjerg bakke 23, 2400 Copenhagen, Denmark.
Drs. Prens and van der Zee: Erasmus Medical Center, Dr. Molewaterplein 50, 3015 GE Rotterdam, the Netherlands.
Dr. Schlessinger: Skin Specialists P.C., 2802 Oak View Drive, Suite 100, Omaha, NE 68144.
Dr. Zouboulis: Departments of Dermatology, Venereology, Allergology, and Immunology, Dessau Medical Center, Auenweg 38, 06847 Dessau, Germany.
Ms. Rosenfeld; Drs. Mulani, Paulson, and Okun; and Ms. Gu: Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064.
Dr. Jemec: University of Copenhagen, Department of Neurology, Psychiatry, and Sensory Sciences, Roskilde Sygehus, Køgevej 7-13, 4000 Roskilde, Denmark.
Author Contributions: Conception and design: A.B. Kimball, U. Mrowietz, E.P. Prens, J. Schlessinger, H.H. van der Zee, M. Rosenfeld, Y. Gu, S. Paulson, M. Okun, G.B.E. Jemec.
Analysis and interpretation of the data: A.B. Kimball, U. Mrowietz, J.M. Gelfand, R. Gniadecki, J. Schlessinger, C.C. Zouboulis, P. Mulani, Y. Gu, S. Paulson, M. Okun, G.B.E. Jemec.
Drafting of the article: A.B. Kimball, E.P. Prens, J. Schlessinger, C.C. Zouboulis, H.H. van der Zee, P. Mulani, Y. Gu, M. Okun, G.B.E. Jemec.
Critical revision of the article for important intellectual content: A.B. Kimball, D. Adams, U. Mrowietz, J.M. Gelfand, R. Gniadecki, E.P. Prens, J. Schlessinger, C.C. Zouboulis, P. Mulani, Y. Gu, M. Okun, G.B.E. Jemec.
Final approval of the article: A.B. Kimball, F. Kerdel, D. Adams, U. Mrowietz, J.M. Gelfand, R. Gniadecki, E.P. Prens, J. Schlessinger, C.C. Zouboulis, H.H. van der Zee, M. Rosenfeld, P. Mulani, Y. Gu, M. Okun, G.B.E. Jemec.
Provision of study materials or patients: A.B. Kimball, F. Kerdel, U. Mrowietz, J.M. Gelfand, R. Gniadecki, E.P. Prens, J. Schlessinger, C.C. Zouboulis, G.B.E. Jemec.
Statistical expertise: J.M. Gelfand, P. Mulani, Y. Gu.
Administrative, technical, or logistic support: M. Rosenfeld.
Collection and assembly of data: A.B. Kimball, U. Mrowietz, J.M. Gelfand, R. Gniadecki, E.P. Prens, J. Schlessinger, H.H. van der Zee, M. Rosenfeld, Y. Gu, G.B.E. Jemec.
Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, et al. Adalimumab for the Treatment of Moderate to Severe Hidradenitis Suppurativa: A Parallel Randomized Trial. Ann Intern Med. 2012;157:846-855. doi: 10.7326/0003-4819-157-12-201212180-00004
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Published: Ann Intern Med. 2012;157(12):846-855.
Hidradenitis suppurativa (HS) is a chronic, painful skin disease characterized by abscesses, nodules, and draining fistulas in the axilla and groin of young adults.
To evaluate the efficacy and safety of adalimumab, an anti–tumor necrosis factor-α antibody, in patients with moderate to severe HS.
Phase 2, parallel, randomized, placebo-controlled trial consisting of a blinded 16-week period (period 1) and an open-label 36-week period (period 2). All study personnel, investigators, and patients remained blinded to treatment group throughout the study. (ClinicalTrials.gov: NCT00918255)
26 academic and private practice medical centers in the United States and Europe.
154 adult patients with moderate to severe HS who were unresponsive or intolerant to oral antibiotics.
Patients were assigned in a 1:1:1 ratio to adalimumab, 40 mg/wk; adalimumab, 40 mg every other week (EOW); or placebo. All patients received adalimumab, 40 mg EOW, at the beginning of period 2 but switched to weekly dosing if the response was suboptimal (HS Physician's Global Assessment [PGA] score of moderate or worse) at weeks 28 or 31.
The primary outcome measure (clinical response) was the proportion of patients achieving an HS-PGA score of clear, minimal, or mild with at least a 2-grade improvement relative to baseline at week 16.
At week 16, 3.9% of placebo patients (2 of 51), 9.6% of EOW patients (5 of 52), and 17.6% of weekly patients (9 of 51) achieved clinical response (EOW vs. placebo strata-adjusted difference, 5.6% [95% CI, −4.0% to 15.3%]; P = 0.25; weekly vs. placebo strata-adjusted difference, 13.7% [CI, 1.7% to 25.7%]; P = 0.025). Serious adverse event rates were 3.9%, 5.8%, and 7.8% for placebo, EOW, and weekly patients, respectively (EOW vs. placebo difference, 1.8% [CI, −6.4% to 10.1%]; weekly vs. placebo difference, 3.9% [CI, −5.2% to 13.0%]). Significantly greater improvements in patient-reported outcomes and pain were seen in the weekly dosing group than in the placebo group. A decrease in response was seen after the switch from weekly to EOW dosing in period 2.
Weeks 16 to 52 of the study were open-label. The study was not powered to assess the risk for known serious adverse effects of adalimumab, such as tuberculosis, other serious infections, and demyelinating disorders.
Adalimumab dosed once per week alleviates moderate to severe HS.
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Hematology/Oncology, Infectious Disease, Mycobacterial Infections.
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