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  • Karpouzas, George A.Harbor UCLA Med Ctr, Div Rheumatol, Torrance, CA USA.;Lundquist Inst, Torrance, CA USA. (författare)

Rheumatoid arthritis disease activity and adverse events in patients receiving tofacitinib or tumor necrosis factor inhibitors : a post hoc analysis of ORAL Surveillance

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • Sage Publications,2023
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-516920
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-516920URI
  • https://doi.org/10.1177/1759720X231201047DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Background: In patients with rheumatoid arthritis (RA), persistent inflammation and increasing disease activity are associated with increased risk of adverse events (AEs).Objectives: To assess relationships between RA disease activity and AEs of interest in patients treated with tofacitinib or tumor necrosis factor inhibitors (TNFi).Design: This was a post hoc analysis of a long-term, postauthorization safety endpoint trial of tofacitinib versus TNFi.Methods: In ORAL Surveillance, 4362 patients aged >= 50 years with active RA despite methotrexate, and >= 1 additional cardiovascular (CV) risk factor, were randomized 1:1:1 to tofacitinib 5 or 10 mg twice daily or TNFi for up to 72 months. Post hoc time-dependent multivariable Cox analysis evaluated the relationships between disease activity [Clinical Disease Activity Index (CDAI)], inflammation [C-reactive protein (CRP)], and AEs of interest. The AEs included major adverse CV events (MACE), malignancies excluding nonmelanoma skin cancer (NMSC), venous thromboembolism (VTE), serious infections, herpes zoster (HZ), nonserious infections excluding HZ (NSI), and death.Results: Across treatments, risk for NSI was higher when patients had CDAI-defined active disease versus remission; MACE and VTE risks trended higher, but did not reach significance. Hazard ratios for MACE, malignancies excluding NMSC, VTE, infections, and death rose by 2-9% for each 5-mg/L increment in serum CRP. The interaction terms evaluating the impact of treatment assignment on the relationship between disease activity and AEs were all p > 0.05.Conclusion: In ORAL Surveillance, higher NSI risk was observed in the presence of active RA versus remission. The risk of MACE and VTE directionally increased in active disease versus remission, although statistical power was limited due to small event numbers in these categories. The relationship between active disease and AEs was not impacted by treatment with tofacitinib versus TNFi.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Szekanecz, ZoltanUniv Debrecen, Fac Med, Dept Rheumatol, Debrecen, Hungary. (författare)
  • Baecklund, Eva,1956-Uppsala universitet,Reumatologi(Swepub:uu)evaba786 (författare)
  • Mikuls, Ted R.Univ Nebraska Med Ctr, Dept Radiol, Omaha, NE 68198 USA.;VA Nebraska Western Iowa Hlth Care Syst, Omaha, NE USA. (författare)
  • Bhatt, Deepak L.Mt Sinai Hlth Syst, Icahn Sch Med, Mt Sinai Heart, New York, NY 10029 USA. (författare)
  • Wang, CunshanPfizer Inc, Inflammat & Immunol, Groton, CT 06340 USA. (författare)
  • Sawyerr, Gosford A.Pfizer Inc, Inflammat & Immunol, New York, NY USA. (författare)
  • Chen, YanPfizer Inc, Inflammat & Immunol, Collegeville, PA USA. (författare)
  • Menon, SujathaPfizer Inc, Inflammat & Immunol, Groton, CT 06340 USA. (författare)
  • Connell, Carol A.Pfizer Inc, Inflammat & Immunol, Groton, CT 06340 USA. (författare)
  • Ytterberg, Steven R.Mayo Clin, Div Rheumatol, Rochester, MN USA. (författare)
  • Mortezavi, MahtaPfizer Inc, Inflammat & Immunol, 66 Hudson Blvd, New York, NY 10001 USA. (författare)
  • Harbor UCLA Med Ctr, Div Rheumatol, Torrance, CA USA.;Lundquist Inst, Torrance, CA USA.Univ Debrecen, Fac Med, Dept Rheumatol, Debrecen, Hungary. (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:Therapeutic Advances in Musculoskeletal Disease: Sage Publications151759-72181759-720X

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