Enabling access to safe and effective autoimmune disease treatments

The University of Manchester has developed a series of world-leading biologic treatment registers to monitor the safety of drugs used to treat conditions such as rheumatoid arthritis. The research has been used to influence national treatment guidelines and increase access to effective treatments.

Ensuring the safety of biologic therapy treatments for patients  

Immune-mediated inflammatory diseases, including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and psoriasis, are chronic and debilitating conditions that affect 3% of the UK population. Biologic therapy treatments (drugs that reduce inflammation) can greatly improve outcomes for patients with these conditions.

However, as these treatments target the patient’s immune system, their use creates concerns about adverse reactions and increased risks of developing other conditions, such as cancer. When these treatments were initially approved for use, only short-term trial data was available, which often does not reflect the populations that are actually being treated.

Combining safety and effectiveness data to deliver results

Multidisciplinary teams at The University of Manchester, such as the Biologic Studies Group, developed a series of world-leading biologics registers to close the evidence gap and track the progress of people prescribed biologic therapies for RA, psoriasis and SLE. These registers collect real-world effectiveness and safety data, benefitting both the clinicians who prescribe the drugs and the patients who take them.

The RA register revealed that administering inflammation-reducing biologic drugs, in this case, anti-tumour necrosis factor (TNF) drugs, to patients with RA does not increase the risk of developing cancer.

Thousands of patients are now able to take their medication with reduced concerns about the possibility of this severe side effect. This register also provides updated safety data to clinicians to ensure patients are offered the most current drug safety information when receiving a prescription.

Bringing new treatments to patients

The European Medicines Agency had concerns about the safety of Tofacitinib, a new treatment for RA from Pfizer, and initially advised against its approval. However, after reviewing data from the University’s RA Register, the agency concluded that the benefits of taking the drug outweighed the risks. Tofacitinib is now licensed and prescribed across Europe, helping tens of thousands of patients.

Drug data continues to be shared with regulators as part of Pfizer’s Risk Management Plan (RMP) for Tofacitinib, which ensures that the safety of drugs is continuously monitored, even after they are licensed for use. 

Increasing access to treatment for NHS patients

Previously, trial data for biologic drugs used to treat certain rare conditions was so limited that these drugs did not attain the level of evidence needed for funding approval by NICE. This meant that many patients were denied access to certain treatments, despite them being licensed for prescription.

One example of this is the drug Belimumab for lupus. The biologics register for lupus is now part of the NICE approval for this drug. Mandatory monitoring of patients with severe lupus through this register enables them to access previously unfunded drugs on the NHS, while further effectiveness and safety data are generated in real time.

Changing prescribing guidelines 

Data from Manchester’s register is also helping to change practice guidelines.

The British Association of Dermatologists used results from the psoriasis register, which show that not all biologics drugs are equally effective for severe psoriasis, to recommend that the drug Ustekinumab is prescribed as the first-line biologic to treat psoriasis in the UK.

This means that patients are now given the most effective and safe treatment available for their condition.