Treatment trials in ankylosing spondylitis: current and future considerations

Area of Science:

• Rheumatology and Immunology
• Clinical Trial Design
• Disease Classification

Background:

• Ankylosing spondylitis (AS) is a chronic, disabling disease with emerging treatment options.
• Understanding AS pathogenesis has led to new classification systems and outcome measures.
• Despite progress, improvements in clinical trial assessment and classification are needed.

Purpose of the Study:

• To review advancements in ankylosing spondylitis (AS) clinical trials.
• To highlight the role of the ASsessments in Ankylosing Spondylitis (ASAS) Working Group.
• To discuss the potential of new classification systems and lessons from rheumatoid arthritis (RA) trials.

Main Methods:

• Review of recent developments in AS research and clinical trials.
• Analysis of consensus-driven outcome measures and classification systems.
• Examination of guidance from regulatory bodies like the US FDA.

Main Results:

• The ASAS Working Group has established core domains and assessment methods for AS trials.
• Improvement and response criteria are being developed for AS treatments.
• Magnetic resonance imaging (MRI) shows promise for future classification criteria.

Conclusions:

• Advancements in AS classification and outcome assessment are vital for drug development.
• Lessons from rheumatoid arthritis (RA) clinical trials, including FDA guidance, can inform AS research.
• Continued collaboration and refinement of trial methodologies will enhance the evaluation of new AS therapies.