PMID- 36600178
OWN - NLM
STAT- MEDLINE
DCOM- 20231002
LR  - 20231011
IS  - 1468-2060 (Electronic)
IS  - 0003-4967 (Print)
IS  - 0003-4967 (Linking)
VI  - 82
IP  - 4
DP  - 2023 Apr
TI  - Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in 
      patients with psoriatic arthritis: final 3-year results from the PsABio 
      real-world study.
PG  - 496-506
LID - 10.1136/ard-2022-222879 [doi]
AB  - OBJECTIVES: To evaluate real-world persistence and effectiveness of the IL-12/23 
      inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic 
      arthritis over 3 years. METHODS: PsABio (NCT02627768), a prospective, 
      observational study, followed patients with PsA prescribed first-line to 
      third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of 
      clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission 
      and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months. 
      Safety data were collected over 3 years. Analyses to compare the modes of action 
      were adjusted on baseline differences by propensity scores (PS). RESULTS: In 895 
      patients (mean age 49.8 years, 44.7% males), at 3 years, the proportion of 
      patients still on their initial treatments was similar with ustekinumab (49.9%) 
      and TNFi (47.8%). No difference was seen in the risk of stopping/switching; 
      PS-adjusted hazard ratio (95% CI) for stopping/switching ustekinumab versus TNFi 
      was 0.87 (0.68 to 1.11). In the overall population, cDAPSA LDA/remission was 
      achieved in 58.6%/31.4% ustekinumab-treated and 69.8%/45.0% TNFi-treated 
      patients; PS-adjusted ORs (95% CI) were 0.89 (0.63 to 1.26) for cDAPSA LDA; 0.72 
      (0.50 to 1.05) for remission. MDA/VLDA was achieved in 41.4%/19.2% of 
      ustekinumab-treated and 54.2%/26.9% of TNFi-treated patients with overlapping 
      PS-adjusted ORs. A greater percentage of TNFi-treated patients achieved 
      effectiveness outcomes. Both treatments exhibited good long-term safety profiles, 
      although ustekinumab-treated patients had a lower rate of adverse events (AEs) 
      versus TNFi. CONCLUSION: At 3 years, there was generally comparable persistence 
      after ustekinumab or TNFi treatment, but AE rates were lower with ustekinumab.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Gossec, Laure
AU  - Gossec L
AUID- ORCID: 0000-0002-4528-310X
AD  - INSERM, Institut Pierre Louis d'Epidemiologie et de Sante Publique, Sorbonne 
      Universite, Paris, France laure.gossec@aphp.fr.
AD  - Rheumatology Department, Pitie-Salpetriere Hospital, AP-HP, Paris, France.
FAU - Siebert, Stefan
AU  - Siebert S
AUID- ORCID: 0000-0002-1802-7311
AD  - University of Glasgow, Glasgow, UK.
FAU - Bergmans, Paul
AU  - Bergmans P
AD  - Janssen-Cilag BV, Breda, The Netherlands.
FAU - de Vlam, Kurt
AU  - de Vlam K
AD  - University Hospitals Leuven, Leuven, Belgium.
FAU - Gremese, Elisa
AU  - Gremese E
AD  - Fondazione Policlinico A Gemelli-IRCCS, Universita Cattolica del Sacro Cuore, 
      Rome, Italy.
FAU - Joven-Ibanez, Beatriz
AU  - Joven-Ibanez B
AD  - University Hospital 12 de Octubre, Madrid, Spain.
FAU - Korotaeva, Tatiana V
AU  - Korotaeva TV
AD  - VA Nasonova Research Institute of Rheumatology, Moscow, Russian Federation.
FAU - Lavie, Frederic
AU  - Lavie F
AD  - The Janssen Pharmaceutical Companies of Johnson & Johnson, Paris, France.
FAU - Noel, Wim
AU  - Noel W
AD  - Janssen Pharmaceutica NV, Beerse, Belgium.
FAU - Nurmohamed, Michael T
AU  - Nurmohamed MT
AUID- ORCID: 0000-0002-6274-1934
AD  - Reade and VU University Medical Center, Amsterdam, The Netherlands.
FAU - Sfikakis, Petros P
AU  - Sfikakis PP
AUID- ORCID: 0000-0001-5484-2930
AD  - National and Kapodistrian University of Athens Medical School, Athens, Greece.
FAU - Sharaf, Mohamed
AU  - Sharaf M
AD  - Johnson & Johnson Middle East, Dubai, UAE.
FAU - Theander, Elke
AU  - Theander E
AD  - Janssen, Solna, Sweden.
FAU - Smolen, Josef S
AU  - Smolen JS
AD  - Medical University of Vienna, Vienna, Austria.
LA  - eng
SI  - ClinicalTrials.gov/NCT02627768
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221213
PL  - England
TA  - Ann Rheum Dis
JT  - Annals of the rheumatic diseases
JID - 0372355
RN  - FU77B4U5Z0 (Ustekinumab)
RN  - 0 (Tumor Necrosis Factor Inhibitors)
RN  - 0 (Antirheumatic Agents)
SB  - IM
MH  - Male
MH  - Humans
MH  - Middle Aged
MH  - Female
MH  - *Arthritis, Psoriatic/drug therapy/chemically induced
MH  - Ustekinumab/therapeutic use
MH  - Tumor Necrosis Factor Inhibitors/therapeutic use
MH  - *Antirheumatic Agents/therapeutic use
MH  - Prospective Studies
MH  - Treatment Outcome
PMC - PMC10086293
OTO - NOTNLM
OT  - Arthritis, Psoriatic
OT  - Biological Therapy
OT  - Tumor Necrosis Factor Inhibitors
COIS- Competing interests: LG reports personal fees from Janssen during the conduct of 
      the study, grants from Amgen, Galapagos, Lilly, Pfizer, Sandoz, UCB, personal 
      fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, 
      Novartis, Pfizer, UCB outside the submitted work. SS reports non-financial 
      support from Janssen during the conduct of the study, personal fees from AbbVie, 
      grants and personal fees from Amgen (previously Celgene), personal fees from 
      Biogen, grants from Boehringer-Ingelheim, grants from Bristol-Myers-Squibb, 
      personal fees from GlaxoSmithKline, grants and personal fees from Janssen, 
      personal fees from Novartis, grants and personal fees from UCB outside the 
      submitted work. PB reports personal fees from Janssen and personal fees from 
      Johnson & Johnson during the conduct of the study. KdV reports personal and 
      consulting fees from Janssen. EG reports payment or honoraria from AbbVie, 
      AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Galapagos, GSK, Janssen, Novartis, 
      Pfizer and Sanofi. BJ-I reports consulting fees from Amgen, Janssen and UCB and 
      payment or honoraria from AbbVie, Eli Lilly, Janssen, Novartis and UCB. TVK 
      reports consulting fees from AbbVie, Amgen, BIOCAD, Eli Lilly, Janssen, MCD, 
      Novartis, Pfizer, Sandoz and UCB, and payment or honoraria from AbbVie, Amgen, 
      BIOCAD, Eli Lilly, Janssen, MCD, Novartis, Pfizer, Sandoz and UCB. FL reports 
      non-financial support from Janssen during the conduct of the study. WM is a 
      full-time employee of and owns stock at Johnson & Johnson. MTN reports grants and 
      non-financial support from Janssen during the conduct of the study, grants and 
      personal fees from AbbVie, grants from BMS, grants and personal fees from Eli 
      Lilly, grants from Amgen, grants from Pfizer, and grants from Galapagos outside 
      the submitted work. PPS reports non-financial support from Janssen during the 
      conduct of the study, grants and personal fees from AbbVie, grants from UCB, 
      grants and personal fees from Eli Lilly, grants and personal fees from Pfizer, 
      grants and personal fees from Novartis, and personal fees from MSD outside the 
      submitted work. MS reports non-financial support from Janssen during the conduct 
      of the study. ET was an employee of Janssen during the conduct of the study and 
      preparation of this paper. JSS has nothing to disclose. LG and MTN are editorial 
      board members at the Annals of the Rheumatic Diseases.
EDAT- 2023/01/05 06:00
MHDA- 2023/10/02 06:42
PMCR- 2023/04/11
CRDT- 2023/01/04 23:26
PHST- 2022/06/01 00:00 [received]
PHST- 2022/11/25 00:00 [accepted]
PHST- 2023/10/02 06:42 [medline]
PHST- 2023/01/05 06:00 [pubmed]
PHST- 2023/01/04 23:26 [entrez]
PHST- 2023/04/11 00:00 [pmc-release]
AID - ard-2022-222879 [pii]
AID - annrheumdis-2022-222879 [pii]
AID - 10.1136/ard-2022-222879 [doi]
PST - ppublish
SO  - Ann Rheum Dis. 2023 Apr;82(4):496-506. doi: 10.1136/ard-2022-222879. Epub 2022 
      Dec 13.