Tofacitinib reduces KL-6 levels in patients with rheumatoid arthritis-associated interstitial lung disease. Results of a phase II investigator-initiated study.
Jorge Rojas-Serrano, Espiridión Ramos-Martínez, Mayra Mejía et al.
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In 30 seconds
This phase II investigator-initiated clinical trial evaluated safety and outcomes with tofacitinib 5 mg twice daily in patients with rheumatoid arthritis-associated interstitial lung disease over 48 weeks. Among 39 participants, 36 (92%) experienced an adverse event, and 15 (38.5/100 patient-years) had the combined outcome of mortality and/or progressive pulmonary fibrosis. FVC changed by -72 mL at 48 weeks. Serum KL-6 declined from a baseline least-squares mean of 34358 mU/mL to 32191 mU/mL, with an LSM decline of -2167 mU/L.
Key findings
- Thirty-six of 39 participants (92%) experienced an adverse event; upper airway respiratory infections were most frequent.
- Three patients died, and 15 (38.5/100 patient-years) experienced mortality and/or progressive pulmonary fibrosis.
- FVC changed by -72 mL over 48 weeks; serum KL-6 LSM declined by -2167 mU/L.
- At the final visit, 51% of patients had low disease activity by the SDAI index.
Why it matters
The trial provides estimates of adverse events and pulmonary and disease-activity outcomes during tofacitinib treatment in RA-ILD, a population in which both lung disease progression and treatment safety are clinically important. The observed KL-6 decline is a biomarker finding; the abstract does not establish that it corresponds to improved lung function or fewer clinical events.
What to keep in mind
The study included 39 patients and followed them for 48 weeks; the abstract does not describe a comparator group.