Hope for improved lung treatment in rheumatoid arthritis

The study is led by the University of Gothenburg in collaboration with Sahlgrenska University Hospital and has been awarded SEK 20 million in funding from the Swedish Research Council for a clinical treatment study. The goal is to address a clear knowledge gap and provide a stronger evidence base for the treatment of a patient group characterized by substantial suffering and high mortality.

“This is a serious and long understudied complication of rheumatoid arthritis. Many patients are diagnosed late, and treatment options are limited. With this study, we aim to take an important step toward more effective and targeted therapies,” says Anna-Karin Hultgård Ekwall.

Chronic inflammation in the lungs

The lung condition under investigation is interstitial lung disease, which involves long-term inflammation and scarring of lung tissue. Up to one in ten people with rheumatoid arthritis are affected and experience progressively worsening shortness of breath and a dry cough. The disease often develops slowly and is therefore diagnosed late. At present, there is no curative treatment, and medications commonly used to treat joint disease have little effect on lung symptoms.

The research focuses on B cells, a type of white blood cell that plays a central role in rheumatoid arthritis, although their role in lung disease is not yet fully understood. The drug rituximab, which reduces B-cell levels, is already used in severe rheumatoid arthritis when other treatments have proven insufficient. Observational studies following patients treated with rituximab in routine clinical care have shown that lung function, at the group level, has stabilized or even improved.

This is the first controlled clinical trial in which patients are randomized to different treatments to evaluate this approach.

Randomized and double-blind

The study, known as BELLRA, will compare rituximab with placebo. Neither the patients nor the study staff will know which treatment is being administered. A total of 120 patients will be enrolled and followed for one year. All participants will continue their standard rheumatoid arthritis treatment and will be randomized to receive rituximab or placebo as an add-on.

The primary outcome is change in lung function. The study will also assess lung oxygenation, patient-reported symptoms, quality of life, and treatment safety.

Image

“Our hypothesis is that early treatment with anti–B cell therapy can slow disease progression when lung function is still mildly to moderately impaired. If successful, the results could significantly influence how these patients are treated in the future,” says Anna-Karin Hultgård Ekwall.

A national network

BELLRA is a national research project conducted in collaboration with rheumatologists, pulmonologists, and thoracic radiologists across six regions in Sweden. The Clinical Research and Trials Unit within rheumatology at Sahlgrenska University Hospital serves as the main trial site, and Region Västra Götaland is the study sponsor. Funding from the Swedish Research Council supports, among other things, a postdoctoral researcher and a PhD student, as well as costs related to healthcare staff, examinations, medications, and data management.

The project is built on an established national network that has emerged through previous studies of early lung involvement in rheumatoid arthritis. Participating researchers from the University of Gothenburg include Anna Rudin, Inger Gjertsson, Eva Klingberg, Jesper Magnusson, and Åse Johnsson.

“Regardless of the outcome, the study will generate knowledge that can be rapidly translated into clinical practice. Our hope is that BELLRA will also pave the way for further treatment studies and ultimately improve health and quality of life for many people with rheumatoid arthritis worldwide,” says Anna-Karin Hultgård Ekwall.