PMID- 32557382
OWN - NLM
STAT- MEDLINE
DCOM- 20210517
LR  - 20210517
IS  - 1179-1888 (Electronic)
IS  - 1175-0561 (Print)
IS  - 1175-0561 (Linking)
VI  - 21
IP  - 4
DP  - 2020 Aug
TI  - Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in 
      an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.
PG  - 567-577
LID - 10.1007/s40257-020-00527-x [doi]
AB  - BACKGROUND: Management of moderate-to-severe atopic dermatitis (AD) commonly 
      requires long-term treatment. OBJECTIVE: The aim of this study was to report the 
      safety and efficacy of dupilumab treatment for up to 3 years in adults with 
      moderate-to-severe AD. METHODS: This ongoing, multicenter, open-label extension 
      study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults 
      previously enrolled in dupilumab trials. Patients received dupilumab 300 mg 
      weekly up to 148 weeks. The primary outcome was safety. RESULTS: Of 2677 patients 
      enrolled and treated, 347 reached week 148. Mean self-reported drug compliance 
      was 98.2%. Safety data were consistent with previously reported trials (270.1 
      adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and 
      the known dupilumab safety profile. Common AEs (>/= 5% of patients) included 
      nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, 
      oral herpes, and injection-site reactions. AD signs and symptoms showed sustained 
      improvements during treatment with mean (standard deviation, mean percentage 
      change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, 
      - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 
      148. LIMITATIONS: No control arm; fewer patients at later time points; regimen 
      different from the approved 300 mg every 2 weeks dose. CONCLUSION: These safety 
      and efficacy results support dupilumab as a continuous long-term treatment for 
      adults with moderate-to-severe AD. TRIAL REGISTRATION: ClinicalTrials.gov: 
      NCT01949311. Dupilumab provides favorable safety and sustained efficacy for up to 
      3 years in an open-label study of adults with moderate-to-severe atopic 
      dermatitis (MP4  139831 kb).
FAU - Beck, Lisa A
AU  - Beck LA
AD  - Department of Dermatology, University of Rochester Medical Center, Rochester, NY, 
      USA.
FAU - Thaci, Diamant
AU  - Thaci D
AD  - University of Lubeck, Lubeck, Germany.
FAU - Deleuran, Mette
AU  - Deleuran M
AD  - Department of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
FAU - Blauvelt, Andrew
AU  - Blauvelt A
AD  - Oregon Medical Research, Portland, OR, USA.
FAU - Bissonnette, Robert
AU  - Bissonnette R
AD  - Innovaderm Research, Montreal, QC, Canada.
FAU - de Bruin-Weller, Marjolein
AU  - de Bruin-Weller M
AD  - National Expertise Center of Atopic Dermatitis, Department of Dermatology and 
      Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
FAU - Hide, Michihiro
AU  - Hide M
AD  - Department of Dermatology, Hiroshima University, Hiroshima, Japan.
FAU - Sher, Lawrence
AU  - Sher L
AD  - Peninsula Research Associates, Rolling Hills Estates, CA, USA.
FAU - Hussain, Iftikhar
AU  - Hussain I
AD  - Vital Prospects Clinical Research Institute, PC, Tulsa, OK, USA.
FAU - Chen, Zhen
AU  - Chen Z
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA.
FAU - Khokhar, Faisal A
AU  - Khokhar FA
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA.
FAU - Beazley, Bethany
AU  - Beazley B
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA.
FAU - Ruddy, Marcella
AU  - Ruddy M
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA.
FAU - Patel, Naimish
AU  - Patel N
AD  - Sanofi, Bridgewater, NJ, USA.
FAU - Graham, Neil M H
AU  - Graham NMH
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA.
FAU - Ardeleanu, Marius
AU  - Ardeleanu M
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA.
FAU - Shumel, Brad
AU  - Shumel B
AD  - Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, 
      USA. brad.shumel@regeneron.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01949311
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PL  - New Zealand
TA  - Am J Clin Dermatol
JT  - American journal of clinical dermatology
JID - 100895290
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 420K487FSG (dupilumab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/*adverse effects
MH  - Conjunctivitis/chemically induced/epidemiology
MH  - Dermatitis, Atopic/diagnosis/*drug therapy/immunology
MH  - Female
MH  - Headache/chemically induced/epidemiology/immunology
MH  - Humans
MH  - Injection Site Reaction/epidemiology/immunology
MH  - Injections, Subcutaneous/adverse effects
MH  - Male
MH  - Medication Adherence/statistics & numerical data
MH  - Middle Aged
MH  - Nasopharyngitis/chemically induced/epidemiology
MH  - Respiratory Tract Infections/chemically induced/epidemiology/immunology
MH  - Self Report/statistics & numerical data
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC7371647
COIS- Lisa A. Beck: AbbVie, LEO Pharma, Pfizer, Regeneron Pharmaceuticals, 
      Inc.-investigator and consultant; Allakos, Arena Pharma, Astra Zeneca, LEO 
      Pharma, Eli Lilly, Novan, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., 
      Sanofi, UCB, Vimalan-consultant; Medtronics, Pfizer-stock owner. Diamant Thaci: 
      AbbVie, Almirall, Amgen, Asana Biosciences, Beiersdorf, Boehringer Ingelheim, 
      Celgene, Dermira, DS Biopharma, Eli Lilly, Galapagos, Galderma, GlaxoSmithKline, 
      Janssen-Cilag, LEO Pharma, Merck Sharp & Dohme, MorphoSys, Novartis, Pfizer, 
      Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi, Sun Pharma, UCB-consultant, 
      advisory board member, and/or investigator. Mette Deleuran: AbbVie, Almirall, Eli 
      Lilly, Galapagos, LEO Pharma, Meda Pharma, Pfizer, Pierre Fabre, Regeneron 
      Pharmaceuticals, Inc., Sanofi Genzyme-received research support and/or honoraria 
      for lecturing, and consulting/advisory board agreements. Andrew Blauvelt: AbbVie, 
      Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers Squibb, 
      Dermavant, Dermira, Eli Lilly, FLX Bio, Forte, Galderma, Janssen, LEO Pharma, 
      Novartis, Ortho Derm, Pfizer, Regeneron Pharmaceuticals, Inc., Sandoz, Sanofi 
      Genzyme, Sun Pharma, UCB-scientific adviser and clinical study investigator; 
      AbbVie-paid speaker. Robert Bissonnette: AbbVie, Aquinox Pharmaceuticals, Arcutis 
      Antiobix, Asana Biosciences, Astellas, Boehringer Ingelheim, Brickell Biotech, 
      Dermavant, Dermira, Dignity Sciences, Eli Lilly, Galderma, Glenmark, 
      GlaxoSmithKline-Stiefel, Hoffman-La Roche, Kiniksa, Incyte, LEO Pharma, NeoKera, 
      Pfizer, Ralexar Therapeutics, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, 
      Vitae-consultant and/or has received grants/research support; Innovaderm 
      Research-shareholder. Marjolein de Bruin-Weller: Regeneron Pharmaceuticals, Inc., 
      Sanofi Genzyme-Principal Investigator, advisory board member, consultant; 
      AbbVie-Principal Investigator, advisory board member; Pfizer, Eli Lilly, 
      UCB-advisory board member. Michihiro Hide: Kaken Pharmaceutical, Kyorin 
      Pharmaceutical, Kyowa Hakko Kirin, Maruho, MDS, Mitsubishi Tanabe Pharma, Sanofi 
      KK, Taiho Pharma, Teikoku Seiyaku, Torii Pharmaceutical, Uriach-honoraria for 
      lectures. Lawrence Sher: Aimmune, Optinose, Regeneron Pharmaceuticals, Inc., 
      Sanofi Genzyme-advisory board member; Regeneron Pharmaceuticals, Inc., Sanofi 
      Genzyme-speaker fees; Aimmune, Amgen, Astra Zeneca, Circassia, DBV, Galderma, 
      GlaxoSmithKline, Lupin, Merck, Mylan, Novartis, Novo Nordisk, Optinose, Pearl, 
      Pfizer, Pulmagen, Roxane, Sanofi, Spirometrix, Teva, Vectura, Watson-clinical 
      trials funding. Iftikhar Hussain: CSL Behring, Genentech, Optinose, 
      Pfizer-advisory board member; AbbVie, AnaptysBio, Asana Biosciences, Astra 
      Zeneca, CSL Behring, Genentech, GlaxoSmithKline, Gossamer Bio, HAL Allergy, 
      Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Merck, Novartis, 
      Optinose, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Shire, Vanda-Principal 
      Investigator. Zhen Chen, Faisal A. Khokhar, Bethany Beazley, Marcella Ruddy, Neil 
      M.H. Graham, Marius Ardeleanu, Brad Shumel: Regeneron Pharmaceuticals, 
      Inc.-employees and shareholders. Naimish Patel: Sanofi-employee, may hold stock 
      and/or stock options in the company.
EDAT- 2020/06/20 06:00
MHDA- 2021/05/18 06:00
PMCR- 2020/06/17
CRDT- 2020/06/20 06:00
PHST- 2020/06/20 06:00 [pubmed]
PHST- 2021/05/18 06:00 [medline]
PHST- 2020/06/20 06:00 [entrez]
PHST- 2020/06/17 00:00 [pmc-release]
AID - 10.1007/s40257-020-00527-x [pii]
AID - 527 [pii]
AID - 10.1007/s40257-020-00527-x [doi]
PST - ppublish
SO  - Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.