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First Biologic Drug for Pulmonary Sarcoidosis in 50 Years Administered at Oxford Hospital

• Infliximab, a TNF-α inhibitor, has become the first new drug approved for pulmonary sarcoidosis in over 50 years, following NHS England commissioning with NICE support.

• The biologic therapy, administered to the first patient at Oxford's John Radcliffe Hospital, offers potential to reduce reliance on broad immunosuppressants that often cause significant side effects.

• Professor Ling-Pei Ho, who led the Oxford Sarcoidosis Service and chaired the initial NHS England working policy group, played a key role in securing the drug's approval for this rare condition affecting 1 in 10,000 UK residents.

In a significant breakthrough for patients with pulmonary sarcoidosis, infliximab has become the first new treatment approved for this condition in more than five decades. The biologic therapy was administered to the first patient at John Radcliffe Hospital, part of Oxford University Hospitals NHS Foundation Trust (OUH), on May 12.
Sarcoidosis is a rare inflammatory condition where the immune system overreacts, causing granulomas—clusters of inflammatory cells—to form primarily in the lungs but potentially affecting multiple organs. The condition affects approximately 1 in 10,000 people in the UK and can range from mild to severe, with patients often requiring multiple immunosuppressant medications that carry significant side effect risks.
Simone Hunter, the first patient to receive infliximab at OUH, expressed optimism about her treatment: "I am excited about the possibility of reducing the number of medications I need. I have been on various immunosuppressants for a long time, and the side effects have started to surface. The commissioning of this drug is very welcome news."

Mechanism and Approval Process

Infliximab works by neutralizing tumor necrosis factor alpha (TNF-α), a protein produced by overactive immune cells in inflammatory conditions like sarcoidosis. This targeted approach potentially reduces the need for broad-spectrum immunosuppressants that can increase infection risks and cause other complications.
The drug has been commissioned by NHS England (NHSE) with support from the National Institute for Health and Care Excellence (NICE). Though already established as a treatment for other inflammatory conditions such as Crohn's disease and rheumatoid arthritis, infliximab will be used as an unlicensed/off-label medicine for pulmonary sarcoidosis patients.
The national commissioning process began in 2016, with Professor Ling-Pei Ho, Consultant in Respiratory Medicine at OUH and lead of the Oxford Sarcoidosis Service, playing a pivotal role. Professor Ho chaired the first NHSE working policy group and contributed to the second, which ultimately led to the drug's approval.
"We are very pleased to be able to offer a new medicine for our patients with severe lung sarcoidosis," said Professor Ho. "Infliximab offers the potential to reduce reliance on broad immunosuppressants in patients with the progressive and destructive form of lung sarcoidosis."

Impact on Patient Care

Pulmonary sarcoidosis can cause debilitating symptoms including shortness of breath and persistent dry cough. Beyond the lungs, the condition can affect the skin, eyes, joints, nervous system, heart, and other organs, making comprehensive treatment challenging.
Traditional management has relied heavily on corticosteroids and other immunosuppressive medications that, while effective at controlling inflammation, often come with substantial side effects when used long-term.
Professor Andrew Brent, Chief Medical Officer at OUH, highlighted the significance of this development: "This is fantastic news for our patients with lung sarcoidosis. The commissioning of this drug is a great example of our teams' dedication to continually improving patient care. It stands as a testament to their unwavering commitment to achieving the best possible outcomes for our patients."

Patient Experience

For patients like Simone Hunter, the availability of infliximab represents not just a new treatment option but potentially a significant improvement in quality of life. "I have always felt well cared for by the team at OUH," Hunter noted. "They have been amazing and accessible, and I have great faith in them. I am truly grateful for their hard work in making this treatment a reality."
The introduction of infliximab for pulmonary sarcoidosis exemplifies how repurposing established medications for new indications can address long-standing treatment gaps. As the first biologic therapy approved for this condition, it may signal a shift toward more targeted approaches in managing complex inflammatory disorders, potentially opening doors for similar innovations in other rare diseases with limited treatment options.
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