Upadacitinib increases time spent with improved AD-related symptoms

Treatment with upadacitinib, an oral selective Janus kinase inhibitor, led to greater proportions of days spent with improved nighttime itch and sleep disturbance experienced by patients with moderate-to-severe atopic dermatitis (AD), according to an integrated analysis of the phase III Measure Up 1 and 2 studies presented at AAD 2024.

The most burdensome effects of AD are itching and sleep disturbance, wherein itching is often aggravated at night and likely contributes to disrupted sleep in patients with AD, according to the researchers.

“[Sleep quality] is essential for optimal physical and mental health, especially for adolescents. Improved sleep is associated with better clinical outcomes for multiple conditions including cardiovascular disease and mental health,” they noted.

Using data from the Measure Up 1 and 2 studies, the researchers evaluated 1,683 adolescents and adults (mean age 15.6 years, 55 percent male) with moderate-to-severe AD who were randomly assigned to receive upadacitinib 15 mg (n=557) or 30 mg (n=567) or placebo (n=559) once daily for 16 weeks. [AAD 2024, abstract 50543]

Time spent with improved nighttime itch

At week 16, patients treated with either dose of upadacitinib spent a significantly higher mean proportion of days with a ≥4-point improvement in nighttime itch from baseline than those treated with placebo (50.9 percent [15 mg] and 62.9 percent [30 mg] vs 13.3 percent; p<0.001 for both doses).

In addition, upadacitinib-treated patients significantly spent more time with no or minimal (score of 0 or 1) nighttime itch in both the 15- and 30-mg dosing groups than in the placebo group (38.7 percent and 52.9 percent, respectively vs 7.6 percent; p<0.001).

Time spent with improved sleep disturbance

Compared with placebo, patients treated with upadacitinib 15 or 30 mg experienced significantly greater mean proportions of days experiencing improvement in sleep disturbance from baseline to week 16 (50.7 percent [15 mg] and 58.2 percent vs 14.4 percent; p<0.001).

The upadacitinib group also had significantly longer periods of no or minimal sleep disturbance compared with the placebo group (41.2 percent [15 mg] and 53.8 percent [30 mg] vs 9.8 percent; p<0.001).

Overall, the mean cumulative number of days with improved nighttime itch was significantly longer by 56.9 and 70.4 days (p<0.001) in the 15- and 30-mg upadacitinib groups, respectively, compared with 14.3 days in the placebo group, as were for sleep disturbance (56.6 and 65.1 vs 15.5 days; p<0.001).

These results were similar among upadacitinib-treated patients with no or minimal nighttime itch (43.5 and 59 days in the 15- and 30-mg cohorts, respectively vs 8.3 days) and sleep disturbance (46.1 and 59.9 vs 10.6 days) than placebo-treated patients.

“Over the 16 weeks, patients who received upadacitinib experienced cumulatively 5- to 7-fold more time spent with no or minimal nighttime itch and 4- to 6-fold more time spent with no or minimal sleep disturbance vs patients receiving placebo, respectively,” the researchers concluded.