Three Years of Upadacitinib Data Offer Reassurance on Laboratory Safety in AD

Long-term laboratory monitoring data from the phase 3 Measure Up 1 and Measure Up 2 trials suggest that upadacitinib (Rinvoq; AbbVie) maintains a stable laboratory safety profile through 140 weeks of treatment in patients with moderate to severe atopic dermatitis (AD). Findings were presented as a poster at the Society for Investigative Dermatology Annual Meeting, held May 13–16, 2026, in Chicago.¹

The analysis, led by David Cotter, MD, of Las Vegas Dermatology, and colleagues, examined trends in lipid panels, liver enzymes, creatine phosphokinase (CPK), and body weight across the combined Measure Up trial population. With upadacitinib now seeing broader real-world use in AD, the data offer clinicians a granular look at what laboratory monitoring may reveal over an extended treatment course.

“Upadacitinib has a well-studied safety profile. This study builds on the increasing amount of safety data for upadacitinib in AD patients, with a specific focus on laboratory abnormalities,” Cotter told Dermatology Times. “The data show that laboratory abnormalities were infrequent, generally transient, and resulted in discontinuation of upadacitinib in fewer than 2% of patients at week 140. This is very reassuring as we enter into the 5th year of treating AD patients clinically with upadacitinib.”

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Study Design

Measure Up 1 (NCT03569293) and Measure Up 2 (NCT03607422) were replicate, randomized, placebo-controlled phase 3 trials evaluating upadacitinib 15 mg and 30 mg once daily in adolescents and adults aged 12 to 75 years with moderate to severe AD. A total of 1213 patients were randomized to upadacitinib at baseline — 603 to the 15-mg dose and 610 to the 30-mg dose — with 601 patients assigned to placebo. At week 16, patients initially on placebo were rerandomized 1:1 to either upadacitinib dose.

Laboratory parameters were assessed at baseline and at scheduled visits through week 140, with descriptive statistics including mean change from baseline and the proportion of patients meeting pre-defined potentially clinically significant thresholds. Exposure-adjusted event rates (EAERs) were calculated for weight change events.

Laboratory Findings

Mean baseline values across all groups were within normal limits for all parameters evaluated, including HDL-C, LDL-C, total cholesterol, triglycerides, AST, ALT, and CPK.

Through 140 weeks, lipid and liver enzyme values largely remained within normal limits in upadacitinib-treated patients. Any changes that did emerge were generally transient, with normalization observed on continued treatment. Grade 3 or higher events were limited: ALT elevations occurred in 0.6% to 1.3% of patients, AST in 1.1% to 2.1%, and CPK in 8.6% to 12.5%. Grade 4 elevations for ALT and AST were rare, occurring in no more than 0.3% of patients; CPK Grade 4 events remained under 6%. Treatment discontinuations related to laboratory abnormalities were uncommon, occurring in 0.7% of patients at week 52 and remaining below 2% through week 140.

CPK elevations were typically mild to moderate in severity. A notable early increase was observed in the 30-mg group at week 4, where mean CPK reached 414.5 U/L — an elevation the investigators attributed largely to exercise or physical exertion. Mean CPK values returned to within normal limits thereafter, and serious CPK events were rare, occurring at fewer than 0.1 events per 100 patient-years.

Weight Changes

Weight gain was infrequent throughout the observation period. In the first 16 weeks, weight increase was reported in 1.8% of patients on upadacitinib 15 mg and 1.9% of those on 30 mg, compared with 0.6% on placebo. Through week 140, EAERs for weight increase were 1.27 events per 100 patient-years in the 15-mg group and 1.79 events per 100 patient-years in the 30-mg group. Weight decrease was similarly infrequent, with EAERs ranging from 0.16 to 0.2 events per 100 patient-years across doses.

Clinical Takeaway

Cotter and colleagues concluded that the overall pattern of laboratory findings over nearly 3 years of treatment supports the long-term safety profile of upadacitinib in this patient population. The transient nature of most laboratory changes, particularly lipid shifts and CPK elevations that resolved without dose modification or discontinuation in the majority of patients, may offer reassurance for clinicians managing patients on extended therapy.

As with all JAK inhibitor use, appropriate baseline laboratory assessment and periodic monitoring remain standard of care.² The data presented here reflect a controlled trial setting, and real-world laboratory trends across broader and more heterogeneous populations will continue to inform clinical practice.

For more atopic dermatitis news and research, register to attend the 2026 Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, held June 17-19. Use code DT40 for 40% off registration.

References

1. Cotter D, Shahriari M, Dasilva D, et al. Long-term laboratory trends in patients with moderate‑to‑severe atopic dermatitis treated with upadacitinib: 140‑week results from measure up 1 and 2. Poster presented at the Society for Investigative Dermatology Annual Meeting, May 13–16, 2026, Chicago, Illinois.
2. Kirchhof MG, Prajapati VH, Gooderham M, et al. Practical recommendations on laboratory monitoring in patients with atopic dermatitis on oral JAK inhibitors. Dermatol Ther (Heidelb). 2024;14(9):2653-2668. doi:10.1007/s13555-024-01243-8