Measurement of mucocutaneous domain activity in a novel treatment response measure for systemic lupus erythematosus clinical trials

Authors

• Kathryn Connelly, Monash University, Australia
• Eric Morand, Monash University, Australia
• Rachel Koelmeyer, Monash University, Australia
• Lavanya Rajagopala, Monash University, Australia
• Ambika Wakhlu, Monash University, Australia
• Yanjie Hao, Monash University, Australia
• Katie Liao, Monash University, Australia
• Darshini Ayton, Monash University, Australia
• Amita Aggarwal, Sanjay Gandhi Postgraduate Institute of Medical Sciences, INDIA
• Angela Migowa, Aga Khan UniversityFollow

Document Type

Article

Department

Paediatrics and Child Health (East Africa)

Abstract

Objectives Previous work by an international taskforce delivered consensus to include rash, mucosal ulcers and alopecia in the mucocutaneous domain of a novel multi-domain clinical outcome measure for systemic lupus erythematosus (SLE) clinical trials, the Treatment Response Measure for SLE (TRM-SLE). (1) Here we report results of a consensus process to define a fit for purpose clinical outcome assessment and entry and response thresholds for assessment of mucocutaneous activity.

Methods A multi-step consensus process was completed by a 18-person working group comprising rheumatologists, dermatologists, and patients with lived experience of mucocutaneous SLE. The domain scope for rash, mucosal ulcers and alopecia for the SLE clinical trial context was defined. Candidate outcome measures were nominated via an online survey. After structured discussion and review of results from the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) working group of the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) addressing outcome measures for trials in cutaneous lupus (CLE), the working group selected a response measure and proceeded to nominal group technique (NGT) to reach consensus on thresholds defining entry and clinically meaningful minimum response.

Results 100% consensus was achieved to define the scopes (figure 1). Rash includes SLE-specific rashes such as acute cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus and chronic cutaneous lupus erythematosus. Mucosal ulcers are limited to oral ulcers confirmed by assessor examination. Alopecia includes CLE-related alopecia and non-scarring alopecia, limited to the scalp. Potential measures of each domain were nominated, with CLASI featuring for all three. After discussion and review of the evidence, including outcomes from the Lupus ABC CLASI working group, there was unanimous agreement to adopt CLASI as the response measure for the mucocutaneous domain in TRM-SLE. Potential CLASI-A thresholds for entry and response were nominated, discussed and ranked via NGT, resulting in consensus on thresholds for entry (CLASI-A >=8) and minimum clinically meaningful response (CLASI-50: CLASI-A reduction by >50%) for use in TRM-SLE. Discussions will be held pending further evidence to define thresholds reflecting complete response.

Conclusions CLASI, with meaningful thresholds for entry and improvement, will be adopted to classify treatment response of mucocutaneous SLE manifestations in TRM-SLE.

Publication (Name of Journal)

Lupus Science & Medicine

DOI

https://doi.org/10.1136/lupus-2026-el.206

Recommended Citation

Connelly, K., Morand, E., Koelmeyer, R., Rajagopala, L., Wakhlu, A., Hao, Y., Liao, K., Ayton, D., Aggarwal, A., Migowa, A. (2026). Measurement of mucocutaneous domain activity in a novel treatment response measure for systemic lupus erythematosus clinical trials. Lupus Science & Medicine, 13(1), 1-2.
Available at: https://ecommons.aku.edu/eastafrica_fhs_mc_paediatr_child_health/618

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License