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Clinical Trial
. 2023 May;42(5):1249-1258.
doi: 10.1007/s10067-023-06513-y. Epub 2023 Jan 30.

Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program

Adriana Maria Kakehasi  1 , Sebastião Cezar Radominski  2 , Marcos Daniel Baravalle  3 , Fedra Consuelo Irazoque Palazuelos  4 , Conrado Garcia-Garcia  5 , Maysa Silva Arruda  6 , Marco Curi  6 , John Liu  7 , Meihua Qiao  7 , Patricia Velez-Sanchez  8 , Juan Ignacio Vargas  9
Affiliations
Clinical Trial

Safety of upadacitinib in Latin American patients with rheumatoid arthritis: an integrated safety analysis of the SELECT phase 3 clinical program

Adriana Maria Kakehasi et al. Clin Rheumatol. 2023 May.

Abstract

Introduction/objectives: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by ongoing inflammation and degradation of synovial joints. The oral JAK inhibitor, upadacitinib, is approved for RA. We conducted an integrated safety analysis of upadacitinib 15 mg once daily (QD) in patients from Latin America (LATAM) versus the rest of the world (RoW).

Methods: Treatment-emergent adverse events (AEs) and laboratory data from six phase 3, randomized controlled trials, adjusted for upadacitinib 15 mg QD use in RA, were analyzed.

Results: Overall, 3209 patients received upadacitinib 15 mg QD for 7024 patient-years (PY). LATAM patients (n = 725) had a mean upadacitinib exposure of 1518 PY. Baseline characteristics were generally similar between LATAM and RoW populations. AE rates (including serious/opportunistic infections, tuberculosis, and herpes zoster) and deaths were comparable between populations. LATAM patients had lower serious AE rates per 100 PY (9.4 vs 14.0 E/100 PY) and discontinuation-related AEs (3.9 vs 6.0 E/100 PY) versus RoW. Rates of cardiovascular events were low (≤ 0.5 E/100 PY) and similar between populations. Malignancies, excluding non-melanoma skin cancer, were less common in the LATAM population versus RoW (0.2 vs 1.0 E/100 PY). Laboratory abnormalities were similar between populations, with decreases in hemoglobin, lymphocyte, and neutrophil counts, and elevations in liver enzymes and creatine phosphokinase. Mean change from baseline in low- and high-density lipoprotein cholesterol was generally comparable between LATAM and RoW populations.

Conclusion: Upadacitinib 15 mg QD demonstrated a consistent safety profile across LATAM and RoW patient populations, with no new safety risks observed.

Trial registration numbers: SELECT-EARLY, NCT02706873; SELECT-NEXT, NCT02675426; SELECT-COMPARE, NCT02629159; SELECT-MONOTHERAPY, NCT02706951; SELECT-BEYOND, NCT02706847; SELECT-CHOICE, NCT03086343.

Keywords: Janus kinase inhibitor; Latin America; Rheumatoid arthritis; Safety; Upadacitinib.

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Conflict of interest statement

AMK has received personal consulting and/or speaking fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Sandoz, Roche, and UCB. SCR has received grants for clinical studies from AbbVie, Bristol-Myers Squibb, and Lilly and speaker fees from AbbVie, Amgen, Janssen, Pfizer, and UCB. MDB has received medical fees as a Clinical Investigator from AbbVie, Galapagos, and GlaxoSmithKline. FCIP has received speaker fees from AbbVie, Pfizer, Bristol-Myers Squibb, and Janssen; consulting fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Janssen, and Pfizer; and medical fees as a Principal Investigator from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Pfizer, and Roche. CGG has received medical fees as a Principal Investigator from AbbVie. MSA, MC, JL, and MQ are employees of AbbVie and may own stock or options. PVS has received medical fees as a Principal Investigator from AbbVie. JIV has received medical fees as a Principal Investigator from AbbVie.

References

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