Rates of Serious Infection Events Similar With Upadacitinib, Adalimumab in Rheumatoid Arthritis

In study data presented at the 2019 ACR Annual Meeting, researchers evaluated the overall safety of upadacitinib as monotherapy and combination therapy with background disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis.

The following article is a part of conference coverage from the 2019 American College of Rheumatology/The Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, being held in Atlanta, Georgia. The team at Rheumatology Advisor will be reporting on the latest news and research conducted by leading experts in rheumatology. Check back for more from the 2019 ACR/ARP Annual Meeting.

ATLANTA – There is no significant difference in the rate of serious infections in patients with rheumatoid arthritis (RA) receiving upadacitinib 15 mg or adalimumab, according to study results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.

However, the results indicated that patients receiving upadacitinib 15 mg and 30 mg had higher rates of herpes zoster compared with patients receiving adalimumab or methotrexate.

The study included data from 5 randomized double-blind, placebo- or active-controlled phase 3 trials of upadacitinib 15 mg (included in all 5 trials) or 30 mg daily (included in 4 trials) in patients with RA.

Researchers calculated the exposure adjusted event rates (EAERs; events/100 patient‐years [PY]) of treatment-emergent adverse events (AEs) for the integrated placebo (3 trials; 12/14 weeks), the integrated methotrexate (2 trials; mean exposure, 36 weeks), the originator adalimumab (mean exposure, 42 weeks), upadacitinib 15 mg (mean exposure, 53 weeks), and upadacitinib 30 mg (mean exposure, 59 weeks) groups.

In all 5 phase 3 trials, 3834 patients received ≥1 dose of upadacitinib 15 mg (n=2630) or 30 mg (n=1204) with no option to switch doses, for a total of 4020.1 PY of upadacitinib exposure.

Similar to patients who received adalimumab, patients who received upadacitinib 15 mg had EAERs of overall serious adverse events (SAEs) and AEs that led to discontinuation. Compared with methotrexate, upadacitinib 15 mg and 30 mg had higher EAERs of both SAEs and AEs.

The most commonly reported AEs were upper respiratory tract infection, nasopharyngitis, and urinary tract infections, all of which occurred more frequently among patients in the upadacitinib groups compared with the placebo group.

Patients in the upadacitinib 15 mg and adalimumab groups had comparable rates of serious infection events (SIEs); however, rates of SIEs were higher among patients receiving upadacitinib compared with methotrexate. Compared with patients receiving methotrexate and adalimumab, patients receiving either dose of upadacitinib had higher rates of herpes zoster.

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Among patients receiving upadacitinib, those in the 15-mg group had lower rates of SIEs and herpes zoster compared with the 30-mg group.

All treatment groups had similar rates of malignancies, excluding non-melanoma skin cancer, and adjudicated major adverse cardiovascular events and venous thromboembolic events. In addition, all treatment groups had comparable rates of death.

Compared with the other treatment groups, upadacitinib 30 mg had a higher rate of non-melanoma skin cancer; however, the rates of non-melanoma skin cancer for both the upadacitinib groups fell within the range reported for patients with RA treated with disease-modifying antirheumatic drugs.

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Cohen S, van Vollenhoven R, Winthrop K, et al. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase 3 clinical program. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 509.

This article originally appeared on Rheumatology Advisor