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Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme.
Ann Rheum Dis. 2020 Oct 28 [Online ahead of print]AR

Abstract

OBJECTIVES

This integrated analysis presents the safety profile of upadacitinib, a Janus kinase inhibitor, at 15 mg and 30 mg once daily in patients with moderately to severely active rheumatoid arthritis (RA).

METHODS

Treatment-emergent adverse events (TEAEs) and laboratory data from five randomised, placebo- or active-controlled phase III trials of upadacitinib for patients with RA were analysed and summarised. Exposure-adjusted event rates are shown for placebo (three trials; 12/14 weeks), methotrexate (two trials; mean exposure: 36 weeks), adalimumab (one trial; mean exposure: 42 weeks), upadacitinib 15 mg (five trials; mean exposure: 53 weeks) and upadacitinib 30 mg (four trials; mean exposure: 59 weeks).

RESULTS

3834 patients received one or more doses of upadacitinib 15 mg (n=2630) or 30 mg (n=1204), for a total of 4020.1 patient-years of exposure. Upper respiratory tract infection, nasopharyngitis and urinary tract infection were the most commonly reported TEAEs with upadacitinib. Rates of serious infection were similar between upadacitinib 15 mg and adalimumab but higher compared with methotrexate. Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg. Rates of deaths, malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs) were similar across treatment groups.

CONCLUSION

In the phase III clinical programme for RA, patients receiving upadacitinib had an increased risk of herpes zoster and CPK elevation versus adalimumab. Rates of malignancies, MACEs and VTEs were similar among patients receiving upadacitinib, methotrexate or adalimumab.

TRIAL REGISTRATION NUMBERS

SELECT-EARLY: NCT02706873; SELECT-NEXT: NCT02675426; SELECT-COMPARE: NCT02629159; SELECT-MONOTHERAPY: NCT02706951; SELECT-BEYOND: NCT02706847.

Authors+Show Affiliations

Metroplex Clinical Research Center, Dallas, Texas, USA arthdoc@aol.com.Amsterdam Rheumatology and Immunology Center, Amsterdam, The Netherlands.Oregon Health and Science University, Portland, Oregon, USA.Centro Universitario Central Paulista, São Paulo, Brazil.University of Occupational and Environmental Health Japan, Kitakyushu, Fukuoka, Japan.Laval University, Quebec City, Quebec, Canada.AbbVie Inc, North Chicago, Illinois, USA.AbbVie Inc, North Chicago, Illinois, USA.AbbVie Inc, North Chicago, Illinois, USA.AbbVie Inc, North Chicago, Illinois, USA.Charité Universitätsmedizin Berlin, Berlin, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33115760

Citation

Cohen, Stanley B., et al. "Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analysis From the SELECT Phase III Clinical Programme." Annals of the Rheumatic Diseases, 2020.
Cohen SB, van Vollenhoven RF, Winthrop KL, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2020.
Cohen, S. B., van Vollenhoven, R. F., Winthrop, K. L., Zerbini, C. A. F., Tanaka, Y., Bessette, L., Zhang, Y., Khan, N., Hendrickson, B., Enejosa, J. V., & Burmester, G. R. (2020). Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Annals of the Rheumatic Diseases. https://doi.org/10.1136/annrheumdis-2020-218510
Cohen SB, et al. Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analysis From the SELECT Phase III Clinical Programme. Ann Rheum Dis. 2020 Oct 28; PubMed PMID: 33115760.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. AU - Cohen,Stanley B, AU - van Vollenhoven,Ronald F, AU - Winthrop,Kevin L, AU - Zerbini,Cristiano A F, AU - Tanaka,Yoshiya, AU - Bessette,Louis, AU - Zhang,Ying, AU - Khan,Nasser, AU - Hendrickson,Barbara, AU - Enejosa,Jeffrey V, AU - Burmester,Gerd R, Y1 - 2020/10/28/ PY - 2020/07/03/received PY - 2020/10/01/revised PY - 2020/10/03/accepted PY - 2020/10/30/pubmed PY - 2020/10/30/medline PY - 2020/10/29/entrez KW - adalimumab KW - arthritis KW - methotrexate KW - rheumatoid JF - Annals of the rheumatic diseases JO - Ann Rheum Dis N2 - OBJECTIVES: This integrated analysis presents the safety profile of upadacitinib, a Janus kinase inhibitor, at 15 mg and 30 mg once daily in patients with moderately to severely active rheumatoid arthritis (RA). METHODS: Treatment-emergent adverse events (TEAEs) and laboratory data from five randomised, placebo- or active-controlled phase III trials of upadacitinib for patients with RA were analysed and summarised. Exposure-adjusted event rates are shown for placebo (three trials; 12/14 weeks), methotrexate (two trials; mean exposure: 36 weeks), adalimumab (one trial; mean exposure: 42 weeks), upadacitinib 15 mg (five trials; mean exposure: 53 weeks) and upadacitinib 30 mg (four trials; mean exposure: 59 weeks). RESULTS: 3834 patients received one or more doses of upadacitinib 15 mg (n=2630) or 30 mg (n=1204), for a total of 4020.1 patient-years of exposure. Upper respiratory tract infection, nasopharyngitis and urinary tract infection were the most commonly reported TEAEs with upadacitinib. Rates of serious infection were similar between upadacitinib 15 mg and adalimumab but higher compared with methotrexate. Rates of herpes zoster and creatine phosphokinase (CPK) elevations were higher in both upadacitinib groups versus methotrexate and adalimumab, and rates of gastrointestinal perforations were higher with upadacitinib 30 mg. Rates of deaths, malignancies, adjudicated major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs) were similar across treatment groups. CONCLUSION: In the phase III clinical programme for RA, patients receiving upadacitinib had an increased risk of herpes zoster and CPK elevation versus adalimumab. Rates of malignancies, MACEs and VTEs were similar among patients receiving upadacitinib, methotrexate or adalimumab. TRIAL REGISTRATION NUMBERS: SELECT-EARLY: NCT02706873; SELECT-NEXT: NCT02675426; SELECT-COMPARE: NCT02629159; SELECT-MONOTHERAPY: NCT02706951; SELECT-BEYOND: NCT02706847. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/33115760/Safety_profile_of_upadacitinib_in_rheumatoid_arthritis:_integrated_analysis_from_the_SELECT_phase_III_clinical_programme L2 - http://ard.bmj.com/lookup/pmidlookup?view=long&pmid=33115760 DB - PRIME DP - Unbound Medicine ER -
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