Patients with atopic dermatitis (AD) achieved rapid changes in skin pain severity via baricitinib treatment through 16 weeks, positively impacting quality of life (QOL). Results were published in the Journal of Cutaneous Medicine and Surgery.
With an estimated prevalence of 4.9% in US adults, AD has been associated with severe reduction in the QOL of patients, including both psychological and physical wellbeing. A major contributing factor cited by patients in regards to discomfort or soreness is skin pain, which is commonly associated with persistent itching.
“The skin pain-itch association may be attributed to the shared mechanisms mediating peripheral and central pain sensitization,” explained the study authors. “The burden of skin pain on the QOL of patients is now starting to be recognized and reveals an unmet need to adequately address this symptom of AD.”
Baricitinib, an oral, selective inhibitor of Janus kinase (JAK) 1 and JAK2, has demonstrated effectiveness in alleviating symptoms of AD, including rapid improvement in skin pain severity. In seeking to further evaluate the onset of action and clinically meaningful skin pain reduction associated with baricitinib, researchers conducted a post hoc analysis of the phase 3 BREEZE-AD5 trial.
Adult patients with moderate to severe AD who were inadequate responders to topical therapies (N = 440) were randomized to once-daily baricitinib 2 mg (n = 146), baricitinib 1 mg (n = 147) or placebo (n = 147) for 16 weeks.
The post hoc analysis examined skin pain via Change in Skin Pain Numeric Rating Scale (NRS) scores, and quality of life via Dermatology Life Quality Index (DLQI) for response groups and patients with body surface area (BSA) 10% to 50%.
“Skin Pain NRS responders are defined as having improvement in Skin Pain NRS greater than or equal to 4 at week 16; Skin Pain NRS nonresponders are defined as having improvement in Skin Pain NRS less than 4 at Week 16.”
In their findings, Skin Pain NRS improvements were significant vs placebo for baricitinib 2 mg (least squares mean [LSM] difference, −0.62%; 95% CI, −0.89 to -0.36; P ≤ .001) and baricitinib 1 mg (LSM difference, −0.56%; 95% CI, −0.83 to -0.30; P ≤ .001 ) starting at week 1 and continuing through week 16.
Regarding QOL, 70.9% of Skin Pain NRS responders vs 10.4% of nonresponders had a clinically meaningful improvement in DLQI at week 16 (P < .0001). LSM [SE] DLQI change from baseline to week 16 was also shown to be significantly greater in Skin Pain NRS responders vs nonresponders (−11.08 [1.042] vs −3.52 [0.373]; P < .0001). Patients with BSA 10% to 50% showed similar trends.
“This prospective study has several strengths, including using validated objective assessments, patient-reported outcomes, and clinical measurements to assess the impact of baricitinib treatment on skin pain and consequently, the impact on QoL,” noted the study authors. “A limitation of this study is it includes a post hoc subgroup analysis of patients from the overall randomized controlled trial.”
Rosmarin D, Fretzin S, Strowd L, et al. Rapid improvement in skin pain severity and its impact on quality of life in adult patients with moderate-to-severe atopic dermatitis from a double-blind, placebo-controlled baricitinib phase 3 study. J Cutan Med Surg. 2022 Mar 31;12034754221088542. doi:10.1177/12034754221088542