Criteria for IIM remission & LDA criteria – MCTC

Developing and Validating “Remission” and “Low Disease Activity” Criteria for Idiopathic Inflammatory Myopathies

RATIONALE:

Remission in idiopathic inflammatory myopathies (IIMs) remains inconsistently defined, creating challenges in comparing clinical trials and real-world outcomes.
Existing literature highlights significant variability in remission definitions, incorporating factors such as physician assessment, muscle strength, laboratory normalization, and treatment discontinuation.
While standardized remission criteria exist for other autoimmune diseases, no unified definition has been established for IIMs.

AIMS:

This initiative aims to develop and validate standardized remission and low disease activity (LDA) criteria for IIMs, considering both overall disease activity and organ-specific involvement (muscle, skin, and lung).

INVESTIGATIONAL STRATEGIES:

Supported by the MCTC Steering Committee, the project will integrate clinical trial data and expert consensus using Multi-Criteria Decision Analysis (MCDA) to establish a data-driven, consensus-based approach.
The goal is to create harmonized remission and LDA criteria that enhance clinical trial design, improve therapeutic outcome assessments, and facilitate regulatory alignment.

TARGETED PROJECT OUTCOMES:

The summary of our initial scoping review on existing remission
definitions and predictive factors across major IIM subtypes (dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy) was submitted as an abstract to the 2025 EULAR Congress.
The review highlighted the substantial heterogeneity in remission rates, with stricter criteria correlating with lower remission rates.
The abstract also underscored the urgent need for unified remission criteria to enable consistent outcome measurement and meaningful comparisons across studies.

We plan to expand on our prior work to develop a formal systematic literature review on this topic and use this new review to submit a full project proposal to ACR/EULAR for sponsorship.
If approved, we will proceed to develop the unified remission criteria as a joint MCTC-ACR/EULAR endeavor.

We welcome participants who are committed to this project, with active engagement in regular online meetings.
We also encourage you to review the full list of projects before signing up.