Clinical trial NCT03104374: A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug
Official title: A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriatic Arthritis
Keywords: Arthritis
Psoriasis
Anti-Rheumatic
Anti-inflammatory
Joint disease
Musculoskeletal disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-04-07
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in subjects with PsA who have completed Period 1.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria
* Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
* Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion Criteria:

* Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib)
* Current treatment with \> 2 non-biologic DMARDs or use of DMARDs other than Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast, Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with LEF at Baseline.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
timeFrame: Baseline and Week 12
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
timeFrame: Baseline and Week 2
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Alabama Medical Group, PC /ID# 159836
state: Alabama
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047
state: Arizona
city: Peoria
country: United States
facility: Sun Valley Arthritis Center Ltd. /ID# 161203
state: Arizona
city: Phoenix
country: United States
facility: Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006
state: Arizona
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center /ID# 161411
state: California
city: Covina
country: United States
facility: Covina Arthritis Clinic /ID# 159919
state: California
city: El Cajon
country: United States
facility: Triwest Research Associates /ID# 159915
state: California
city: Fullerton
country: United States
facility: Duplicate_Providence Medical Foundation /ID# 160005
state: California
city: Hemet
country: United States
facility: C.V. Mehta MD, Med Corporation /ID# 161192
state: California
city: Huntington Beach
country: United States
facility: Care Access Research, Huntington Beach /ID# 160049
state: California
city: La Mesa
country: United States
facility: Purushotham & Akther Kotha MD, Inc /ID# 159834
state: California
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 161402
state: California
city: Upland
country: United States
facility: Inland Rheum Clin Trials Inc. /ID# 159839
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research /ID# 160045
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic /ID# 159899
state: Colorado
city: Lakewood
country: United States
facility: Colorado Arthritis Associates /ID# 159856
state: Colorado
city: Aventura
country: United States
facility: Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research /ID# 160051
state: Florida
city: Miami Lakes
country: United States
facility: Precision Research Organization /ID# 161293
state: Florida
city: New Port Richey
country: United States
facility: Duplicate_Suncoast Clinical Research /ID# 161417
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research /ID# 159833
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc. /ID# 163463
state: Florida
city: Pensacola
country: United States
facility: Gulf Region Clinical Res Inst /ID# 159860
state: Florida
city: Saint Petersburg
country: United States
facility: BayCare Medical Group /ID# 161405
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center /ID# 159854
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates /ID# 161412
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida - Tampa /ID# 160069
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc /ID# 159840
state: Florida
city: Tampa
country: United States
facility: USF Health Morsani Center for /ID# 161291
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group, Inc. /ID# 159912
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic /ID# 160013
state: Florida
city: Decatur
country: United States
facility: Jefrey D. Lieberman, MD, P.C. /ID# 159842
state: Georgia
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology /ID# 161201
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise /ID# 159922
state: Idaho
city: Chicago
country: United States
facility: Great Lakes Clinical Trials /ID# 163438
state: Illinois
city: Libertyville
country: United States
facility: Deerbrook Medical Associates /ID# 159815
state: Illinois
city: Skokie
country: United States
facility: Duplicate_Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 160068
state: Illinois
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic, Inc. /ID# 161294
state: Louisiana
city: Frederick
country: United States
facility: Arthritis Treatment Center /ID# 160053
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research /ID# 159900
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group /ID# 158712
state: Massachusetts
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 161208
state: Missouri
city: Omaha
country: United States
facility: Westroads Clinical Research /ID# 160004
state: Nebraska
city: Toms River
country: United States
facility: Atlantic Coast Research /ID# 159810
state: New Jersey
city: Las Cruces
country: United States
facility: Duplicate_Arthritis and Osteo Assoc /ID# 160015
state: New Mexico
city: Albany
country: United States
facility: Center for Rheumatology LLP /ID# 167046
state: New York
city: Potsdam
country: United States
facility: St. Lawrence Health System /ID# 159857
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC /ID# 161414
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, PA /ID# 159898
state: North Carolina
city: Raleigh
country: United States
facility: Shanahan Rheuma & Immuno /ID# 160012
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington LLC /ID# 161403
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Med Arts Clinic /ID# 159811
state: North Dakota
city: Vandalia
country: United States
facility: STAT Research, Inc. /ID# 161416
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma /ID# 159913
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 159861
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 161193
state: Pennsylvania
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462
state: South Carolina
city: Knoxville
country: United States
facility: Rheumatology Consultants, PLLC /ID# 161408
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh Gupta /ID# 160067
state: Tennessee
city: Austin
country: United States
facility: Tekton Research, Inc. /ID# 160008
state: Texas
city: Beaumont
country: United States
facility: Diagnostic Group /ID# 161406
state: Texas
city: College Station
country: United States
facility: Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 163439
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop-Moody MD Clinic PA /ID# 160009
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research /ID# 159818
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clin Res Ctr /ID# 161252
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research /ID# 160052
state: Texas
city: Lufkin
country: United States
facility: P&I Clinical Research /ID# 159837
state: Texas
city: Mesquite
country: United States
facility: SW Rheumatology Res. LLC /ID# 160014
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball /ID# 161753
state: Texas
city: Waco
country: United States
facility: Arthritis & Osteoporosis Clinic /ID# 161400
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic of N. VA, P.C /ID# 159858
state: Virginia
city: Seattle
country: United States
facility: Duplicate_Swedish Medical Center /ID# 159918
state: Washington
city: Botany
country: Australia
facility: Emeritus Research Sydney /ID# 166751
state: New South Wales
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital /ID# 200840
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital /ID# 166752
state: Victoria
city: Heidelberg West
country: Australia
facility: Heidelberg Repatriation Hospital /ID# 167441
state: Victoria
city: Genk
country: Belgium
facility: ReumaClinic /ID# 164214
state: Limburg
city: Gent
country: Belgium
facility: UZ Gent /ID# 164210
state: Oost-Vlaanderen
city: Goiânia
country: Brazil
facility: CIP - Centro Internacional de Pesquisa /ID# 161808
state: Goias
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC /ID# 163489
state: La Spezia
city: Uberlândia
country: Brazil
facility: Hospital de Clínicas da Universidade Federal de Uberlândia /ID# 161794
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 161795
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 161806
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Duplicate_Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 163317
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 161793
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 157835
state: British Columbia
city: Winnipeg
country: Canada
facility: CIADS Research Co Ltd /ID# 157843
state: Manitoba
city: Orillia
country: Canada
facility: The Waterside Clinic /ID# 157838
state: Ontario
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 157836
state: Quebec
city: Trois-rivières
country: Canada
facility: Centre de Recherche Musculo-Squelettique /ID# 163557
state: Quebec
city: Providencia
country: Chile
facility: CTR Estudios Clinicos /ID# 206038
state: Aisen Del General Carlos Ibanez Del Campo
city: Santiago
country: Chile
facility: Duplicate_Clinica Dermacross /ID# 169537
city: Santiago
country: Chile
facility: Duplicate_Centro Internacional de Estudios Clinicos /ID# 169543
city: Santiago
country: Chile
facility: Prosalud Ltda. /ID# 169542
city: Prostejov
country: Czechia
facility: Revmatologie Bruntal, s.r.o /ID# 159632
city: Uherske Hradiste
country: Czechia
facility: Medical Plus, s.r.o. /ID# 159631
city: Marseille
country: France
facility: Hopital Saint Joseph /ID# 163755
state: Bouches-du-Rhone
city: Toulouse
country: France
facility: CHU Toulouse /ID# 163743
state: Occitanie
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 163746
state: Sarthe
city: Chambray Les Tours
country: France
facility: CHRU Tours - Hopital Trousseau /ID# 163772
city: Creteil
country: France
facility: Duplicate_CHU-Hospital Henri Mondor /ID# 163895
city: Paris
country: France
facility: Duplicate_AP-HP - Hopital Lariboisiere /ID# 163773
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 163474
state: Attiki
city: Athens
country: Greece
facility: Naval Hospital of Athens /ID# 163495
city: Larisa
country: Greece
facility: Reg Gen Univ Hosp Larissa /ID# 163493
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 162573
state: Gyor-Moson-Sopron
city: Veszprém
country: Hungary
facility: Vital Medicina Kft /ID# 162571
state: Veszprem
city: Budapest
country: Hungary
facility: Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 170911
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo /ID# 162575
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft. /ID# 162576
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 162572
city: Szolnok
country: Hungary
facility: MÁV Kórház /ID# 162574
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II /ID# 202410
state: L Aquila
city: Rome
country: Italy
facility: Duplicate_Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 164123
state: Roma
city: Rome
country: Italy
facility: Duplicate_Fondazione PTV Policlinico Tor Vergata /ID# 162749
state: Roma
city: Ancona
country: Italy
facility: Duplicate_Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 162748
city: Catania
country: Italy
facility: Duplicate_A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 164126
city: Cona
country: Italy
facility: Duplicate_AOU Arcispedale Sant Anna di /ID# 164127
city: Milan
country: Italy
facility: ASST Gaetano Pini/Presidio Ospedaliero Pini /ID# 164125
city: Reggio Emilia
country: Italy
facility: Duplicate_Azienda Unita Sanitaria Locale/IRCCS /ID# 162751
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 162563
state: Aichi
city: Nagoya-shi
country: Japan
facility: Daido Hospital /ID# 163639
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 161774
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Duplicate_Kitakyushu Municipal Medical Center /ID# 163516
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Hospital of the University of Occupational and Environmental Health, Japan /ID# 161472
state: Fukuoka
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical University Hospital /ID# 200684
state: Hokkaido
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 162085
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 164035
state: Miyagi
city: Oita-shi
country: Japan
facility: Oribe Clinic of Rheumatism and Medicine /ID# 163704
state: Oita
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 162081
state: Osaka
city: Kawachinagano Shi
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center /ID# 162589
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 162082
state: Osaka
city: Osaka-shi
country: Japan
facility: Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 161773
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 162089
state: Tokyo
city: Chuo-ku
country: Japan
facility: St.Luke's International Hospital /ID# 162013
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 162130
state: Tokyo
city: Suwon
country: Korea, Republic of
facility: Duplicate_Ajou University Hospital /ID# 163893
state: Gyeonggido
city: 중구
country: Korea, Republic of
facility: Duplicate_Inha University Hospital /ID# 163892
state: Incheon Gwang Yeogsi
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 163049
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Duplicate_Erasmus Medisch Centrum /ID# 163052
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis /ID# 163050
state: Zuid-Holland
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek /ID# 163703
city: Otahuhu
country: New Zealand
facility: Duplicate_Middlemore Hospital /ID# 166411
state: Auckland
city: Timaru
country: New Zealand
facility: Timaru Medical Specialists Ltd /ID# 166410
state: Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 166412
state: Waikato
city: Nelson
country: New Zealand
facility: Porter Rheumatology Ltd /ID# 200422
city: Vila Nova De Gaia
country: Portugal
facility: Duplicate_Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 165897
state: Porto
city: Ponte de Lima
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 165898
state: Viana Do Castelo
city: Lisboa
country: Portugal
facility: Instituto Portugues De Reumatologia /ID# 165894
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz /ID# 165896
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 165895
city: Carolina
country: Puerto Rico
facility: Alma M. Cruz Santana, MD-Private practice /ID# 163308
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation /ID# 163918
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 163716
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca /ID# 163138
state: Murcia
city: A Coruna
country: Spain
facility: Duplicate_Hospital Universitario A Coruna - CHUAC /ID# 161019
city: Cordoba
country: Spain
facility: Duplicate_Hospital Universitario Reina Sofia /ID# 170764
city: Granada
country: Spain
facility: Hospital Campus de la Salud /ID# 170768
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 161020
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath /ID# 161054
state: Bath And North East Somerset
city: London
country: United Kingdom
facility: Barts Health NHS Trust /ID# 161053
state: London, City Of
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 161063
state: London, City Of
city: Glasgow
country: United Kingdom
facility: Duplicate_NHS Greater Glasgow and Clyde /ID# 162712
city: Luton
country: United Kingdom
facility: Duplicate_Bedfordshire Hospitals NHS Foundation Trust /ID# 162713
city: Poole
country: United Kingdom
facility: Duplicate_Christchurch University Hospitals Dorset NHS University Hospitals Dors /ID# 162711
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23.
citation: Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30.
citation: Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905.
citation: Strand V, Van den Bosch F, Ranza R, Leung YY, Drescher E, Zueger P, Saffore CD, Lertratanakul A, Lippe R, Nash P. Patient-Reported Outcomes in Psoriatic Arthritis Patients with an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: SELECT-PsA 2. Rheumatol Ther. 2021 Dec;8(4):1827-1844. doi: 10.1007/s40744-021-00377-x. Epub 2021 Oct 18.
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