PMID- 37695506
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231119
IS  - 2198-6576 (Print)
IS  - 2198-6584 (Electronic)
IS  - 2198-6576 (Linking)
VI  - 10
IP  - 6
DP  - 2023 Dec
TI  - Treatment with Upadacitinib in Active Psoriatic Arthritis: Efficacy and Safety 
      Data of the First 192 Patients from the UPJOINT Study, a Multicentre, 
      Observational Study in Clinical Practice.
PG  - 1503-1518
LID - 10.1007/s40744-023-00589-3 [doi]
AB  - INTRODUCTION: Our aim was to investigate the efficacy and safety of upadacitinib 
      (UPA) in patients with either oligo- or polyarticular active psoriatic arthritis 
      (PsA) using routine clinical practice data from an observational, prospective, 
      multicentre study. METHODS: This interim analysis contains upadacitinib efficacy 
      and safety data from the UPJOINT study, collected from baseline to the week 24 
      visit with a focus on composite measures, clinical assessments and 
      patient-reported outcomes, amongst others, including minimal disease activity 
      (MDA), very low disease activity (VLDA), Disease Activity Index for Psoriatic 
      Arthritis (DAPSA), Leeds Enthesitis Index (LEI), resolution of dactylitis and 
      nail psoriasis and body surface area affected by skin psoriasis (BSA). RESULTS: A 
      total of 296 patients with baseline data and 192 with completed week 24 visits 
      were included in the analysis. The proportion of patients achieving MDA increased 
      from 2.7% at baseline to 39.1% at week 24 (95% CI 32.1, 46.3). Similarly, the 
      number of patients in DAPSA remission (DAPSA </= 4) increased from 0 at baseline to 
      32 (16.7%) by week 24. At that time, 59.4% of the patients were either in DAPSA 
      remission or had low disease activity (DAPSA </= 14). During the 24 weeks time 
      frame, the proportion of patients with BSA </= 3 increased from 80.7% to 91.1%. 
      Furthermore, at weeks 12 and 24, 45.14% and 47.19% of affected patients showed a 
      resolution of enthesitis. Active dactylitis and nail psoriasis at baseline were 
      reported to affect 10.5% and 22.0%, decreasing to 2.6% and 5.7% at week 24, 
      respectively. The safety findings are consistent with the known safety profile of 
      upadacitinib in rheumatoid arthritis and PsA; no new safety risks were 
      identified. CONCLUSION: The data from this study confirm the findings of previous 
      randomized controlled trials suggesting UPA is an effective treatment for active 
      PsA without any new safety signals in patients from daily clinical practice. 
      CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04758117.
CI  - (c) 2023. The Author(s).
FAU - Werner, Stephanie G
AU  - Werner SG
AUID- ORCID: 0000-0002-6566-3740
AD  - RHIO (Rheumatology, Immunology and Osteology) Duesseldorf and RHIO Research 
      Institute, Dusseldorf, Germany.
FAU - Baraliakos, Xenofon
AU  - Baraliakos X
AD  - Rheumazentrum Ruhrgebiet, Ruhr University Bochum, Herne, Germany.
FAU - Reckert, Sabine
AU  - Reckert S
AD  - Rheumatology and Osteology Practice, Potsdam, Germany.
FAU - Bohl-Buhler, Martin
AU  - Bohl-Buhler M
AD  - Rheumahaus Potsdam GbR, Potsdam, Germany.
FAU - Laliberte, Marie-Claude
AU  - Laliberte MC
AUID- ORCID: 0000-0003-0178-1331
AD  - AbbVie Canada, St. Laurent, QC, Canada.
FAU - Girard, Tanya
AU  - Girard T
AD  - AbbVie Canada, St. Laurent, QC, Canada.
FAU - Jeromin, Katharina
AU  - Jeromin K
AD  - AbbVie Deutschland GmbH and Co. KG, Wiesbaden, Germany.
FAU - Baschuk, Nikola
AU  - Baschuk N
AD  - AbbVie Deutschland GmbH and Co. KG, Wiesbaden, Germany.
FAU - Fritz, Bjorn
AU  - Fritz B
AD  - AbbVie Deutschland GmbH and Co. KG, Wiesbaden, Germany.
FAU - Bessette, Louis
AU  - Bessette L
AUID- ORCID: 0000-0002-6834-2731
AD  - Groupe de Recherche en Rhumatologie et Maladies Osseuses (GRMO), Quebec, QC, 
      Canada.
FAU - Hueber, Axel J
AU  - Hueber AJ
AUID- ORCID: 0000-0001-6454-1234
AD  - Department of Internal Medicine 3-Rheumatology and Immunology, 
      Friedrich-Alexander-University Erlangen-Nurnberg and Universitatsklinikum 
      Erlangen, Erlangen, Germany. axel.hueber@fau.de.
AD  - Division of Rheumatology, Klinikum Nurnberg, Paracelsus Medical University, 
      Prof.-Ernst-Nathan-Str. 1, 90419, Nuremberg, Germany. axel.hueber@fau.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT04758117
PT  - Journal Article
DEP - 20230911
PL  - England
TA  - Rheumatol Ther
JT  - Rheumatology and therapy
JID - 101674543
PMC - PMC10654267
OAB - Upadacitinib is an antirheumatic medical therapy approved for treating psoriatic 
      arthritis with insufficient response to previous conventional or biological 
      therapies (DMARD-IR). Psoriatic arthritis is a chronic inflammatory disease 
      affecting the joints, spine, tendons/entheses, skin, nails and other parts of the 
      musculoskeletal system. Early diagnosis and treatment initiation are essential 
      for patients with psoriatic arthritis given the potentially irreversible damage 
      to joints, spine, and entheses and the considerable impact on quality of life. 
      The results presented in this manuscript help clinicians evaluate whether the 
      efficacy and the safety profile of upadacitinib found in previous clinical trials 
      can be reproduced in patients seen in daily clinical practice. This analysis 
      presents descriptive data on the real-world efficacy and safety of upadacitinib, 
      measured by clinical and patient-reported outcomes assessed in four visits over 
      24 weeks. In summary, our findings confirm the results of previous clinical 
      trials showing that upadacitinib effectively reduces symptom severity of PsA and 
      substantially increases the proportion of patients achieving treatment goals 
      relevant to clinical practice, such as remission or very low disease activity. In 
      addition, safety data were consistent with previous studies of upadacitinib in 
      rheumatoid arthritis or psoriatic arthritis; no new risks to the patients' safety 
      were identified.
OABL- eng
OTO - NOTNLM
OT  - Disease activity index for psoriatic arthritis
OT  - Efficacy
OT  - Minimal disease activity
OT  - Patient-reported outcomes
OT  - Psoriatic arthritis
OT  - Remission
OT  - Safety
OT  - Upadacitinib
OT  - Very low disease activity
COIS- Axel J Hueber consultant or speaker: Abbvie, BMS, Eli Lilly, Galapagos, Gilead, 
      Novartis, UCB; Funding for investigator-initiated studies: Novartis. Stephanie G 
      Werner consultant/honoraria: Abbvie, Janssen-Cilag, Lilly, Pfizer, UCB. Xenofon 
      Baraliakos consultant, speakers bureau, scientific advisory board and honoraria: 
      Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer, 
      Roche, Sandoz, UCB. Sabine Reckert participated in non-interventional trials of 
      AbbVie and declares no further conflicts of interest. Martin Bohl-Buhler 
      participated in non-interventional trials of AbbVie GmbH & Co. KG, AMS Advanced 
      Medical Services GmbH, BMS via inVentiv Health Clinical#, Charite 
      Universitatsmedizin Berlin, Covance Inc., Galapagos, MSD SHARP & DOHME GMBH, 
      Novartis Pharma GmbH, Pfizer Pharma GmbH, PPD Global Ltd, Rheumatologische 
      Fortbildungsakademie, Roche Pharma AG, Sanofi-Aventis Deutschland GmbH, UCB 
      Biosciences GmbH, Winicker Norimed GmbH and received honoraria for lectures and 
      participation in advisory boards from AbbVie Deutschland GmbH & Co. KG, Amgen 
      GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Galapagos Biopharma Germany 
      GmbH, Gilead Sciences Europe Ltd., GILEAD Sciences GmbH, Hexal AG, Janssen-Cilag 
      GmbH, Lilly Deutschland GmbH, MICE Service GmbH fur Mylan Germany Team, MSD SHARP 
      & DOHME GMBH, Novartis Pharma GmbH, Roche Pharma AG, Theramex Germany GmbH, UCB 
      Pharma GmbH. Louis Bessette Speaker: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, 
      Merck, Lilly, Novartis, Sanofi, Sandoz, Fresenius Kabi, Teva, Organon, JAMP 
      Pharma; Consultant: Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Lilly, 
      Novartis, Sanofi, Sandoz, Fresenius Kabi, Teva, Organon, JAMP Pharma; Research: 
      Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, 
      Novartis, Gilead, JAMP Pharma. Marie-Claude Laliberte, Nikola Baschuk, Katharina 
      Jeromin, Bjorn Fritz and Tanya Gerard are employees of AbbVie Corporation and may 
      own AbbVie stocks and/or options.
EDAT- 2023/09/11 12:43
MHDA- 2023/09/11 12:44
PMCR- 2023/09/11
CRDT- 2023/09/11 11:14
PHST- 2023/04/28 00:00 [received]
PHST- 2023/07/28 00:00 [accepted]
PHST- 2023/09/11 12:44 [medline]
PHST- 2023/09/11 12:43 [pubmed]
PHST- 2023/09/11 11:14 [entrez]
PHST- 2023/09/11 00:00 [pmc-release]
AID - 10.1007/s40744-023-00589-3 [pii]
AID - 589 [pii]
AID - 10.1007/s40744-023-00589-3 [doi]
PST - ppublish
SO  - Rheumatol Ther. 2023 Dec;10(6):1503-1518. doi: 10.1007/s40744-023-00589-3. Epub 
      2023 Sep 11.