Using BADBIR to Examine the Safety of Biologics over Systemics

BADBIR sounds like something you want to send back on a Saturday night, but instead its another acronym. This one though- is worth knowing about.

What is BADBIR?

BADBIR stands for the British Association of Dermatologists Biologic and Immunomodulators Register. And if your thinking- ahhh the Brits that's not of interest to me then stop right there.

The U.K is an ideal site to mine health data because almost the entire populations receive their healthcare from one organization- the NHS. This means that a whole populations health data can be stored in one place- not over 2,000 different health insurance companies confidential databases (or under your bed).

How is BADBIR helpful?

BADBIR is a UK and Eire observational study whose aim is to collect data from people taking biologics to assess the long term impact (clinical trials are not very long). It is basically a database of people who are taking biologic treatments which stores information about physical health, mental health, drugs that are taken, their impact and any side effects. The data is used to investigate the safety and effectiveness of different biologic therapies, as well as to learn more about psoriasis itself and its co-morbidities.

Inclusion is voluntary, with 160 hospitals and 17,000 people registered (and a goal of 20,000 by 2028) there is a lot of data being funneled into this database which tracks not only treatments, but treatment outcomes and involves the regular completion of Quality of Life assessments so the broader impact of psoriasis can be investigated.¹

What kind of questions is it used to answer?

The data is being used to answer a number of questions around biologic use, such as "Is the risk of serious infection greater when using biologics over non-biologic systemic treatment?"

Dr. Yiu used BADBIR to obtain data for 9,038 people to answer this commonly asked question- am I more likely to get a serious infection if I take a biologic?

Examining serious infection risk when taking a biologic

He investigated data based on patients with plaque psoriasis who were classed as moderate to severe according to PASI and DLQI scores. Standard practice for eligibility for biologic treatment in the U.K.

• 1,352 people were taking etanercept
• 3,271 people were taking adalimumab
• 994 people were taking ustekinumab

A total of 5,617 people on biologic therapy. 3,421 people were taking nonbiologic systemic therapy (and had never tried biologics). These included: Acitretin, Psoralen-UVA, Cyclosporine, Fumaric acid esters, Methotrexate and Hydroxycarbamide.²

What did the researchers find?

There was no significant risk increase with any of the biologic therapies when compared to non-biologic systemics when the numbers are crunched through statistical programs. Statistical programs are used to remove the risk of our opinions clouding the conclusions.

I was surprised to hear this when I saw Dr. Yiu present his findings.

I had expected a higher risk with biologics, though now I have had time to reflect, perhaps I simply had an unrealistic and naive risk perception of systemics. When I took first took Cyclosporine I was in my early twenties, and the second time I was desperate. Naivety and desperation are not great for motivating an unbiased view of the research. It is therefore important for me to highlight a few points.

Applying this knowledge to your own treatment journey

While the risk between both sets of treatments, statistically was not significant, it is important to remember that these results show statistics- calculations based on the results of thousands of people averaged together. You are you, and you may have another aspect of your health or circumstances that make the leap to biologics more dangerous- talk this through thoroughly with your doctor.

It's also worth noting that 283 people of the 9,038 did develop a severe infection (classed as requiring a more extended hospital stay and IV anti-biotics or death). The most common of which were lower respiratory tract infections, skin and soft tissue infections, and infections of the urinary tract.²

These drugs do affect the immune system, and you do need to have a close relationship with your healthcare team when you take them.