Effects of tofacitinib vs methotrexate on clinical and molecular disease activity markers in joints and lungs in early rheumatoid arthritis (PULMORA)

Pulmonary abnormalities are prevalent in patients with early rheumatoid arthritis (RA) but often undiagnosed or neglected in clinical praxis. Up to 10% of RA patients will develop interstitial lung disease (ILD) with high mortality. Identification of these patients is hampered by a lack of specific symptoms and diagnostic tools.

No specific treatment is available and some anti-rheumatic drugs have even been suggested to contribute to ILD. Recent data indicate that novel Janus kinase inhibitors (JAKi) could be beneficial.

The aim of the PULMORA study is to determine whether the JAKi tofacitinib, registered for RA, is an effective and safe treatment for patients with interstitial pulmonary findings on High resolution computed tomography (HRCT) at diagnosis.

PULMORA is a 48 weeks randomized controlled multicentre trial, designed and performed by a network of experts in the field. The primary objective is effects of tofacitinib vs standard-of-care methotrexate on ILD changes by HRCT at 24 weeks.

A sub study will explore disease mechanisms on tissue samples collected by ultrasound-guided synovial biopsy, bronchoalveolar lavage and Particles in Exhaled Air. A pilot study starting fall 2020 aims at optimizing the protocol. Our overall goal is to increase the knowledge on pathogenesis, assessment and treatment of RA-ILD.

The results will have a broad impact on clinical decisions and outcome for a majority of RA patients and are easily implemented in clinical practice worldwide.