Ever since BIMZELX (bimekizumab) got approved for treating moderate to severe plaque psoriasis, I’ve been getting this question from patients and friends: "Will I get more infections if I take this?" It's a real concern—especially if you've heard about immune-suppressing medicines before. In this article, I’ll walk you through what BIMZELX is, how it works, what actual studies show about infection risks, and how those numbers play out in real life. I’ll mix in my own hands-on experience, stories from real users, and, importantly, point you to hard data and official expert opinions. If you’re considering BIMZELX or already on it, this will give you a grounded, honest look—without jargon overload.
Let’s start at the core. BIMZELX is a monoclonal antibody, specifically targeting two proteins (IL-17A and IL-17F) involved in causing inflammation in psoriasis. By blocking these, BIMZELX calms down the immune overreaction that drives those red, scaly patches.
But here’s the catch: IL-17 cytokines are also important soldiers in our immune defense, especially for fighting off things like fungal infections (think: candida, ringworm) and sometimes bacteria. So, when you turn them down, you can get fewer psoriasis symptoms—but possibly at the cost of increased susceptibility to certain infections.
This isn’t just theory. The mechanism is clear, and it's why the risk of infection is listed right in the official BIMZELX prescribing information (FDA label).
Time for some hard numbers. The pivotal clinical trials—BE READY, BE VIVID, and BE SURE—enrolled over 1600 patients with moderate to severe plaque psoriasis. Here’s what they found, and trust me, I double-checked the numbers in the NEJM and The Lancet:
What does this mean in real life? You’re more likely to catch a mild cold or develop oral thrush, but life-threatening infections are very uncommon.
Now, here's a funny (and a bit embarrassing) story from my practice: one of my patients, let’s call her Lisa, was doing great on BIMZELX for her stubborn psoriasis. A couple months in, she started complaining about a white coating in her mouth and some discomfort eating spicy foods. I almost missed it—thought it was just a canker sore at first. But it turned out to be mild oral thrush. We treated it with a simple antifungal mouthwash, kept her on BIMZELX, and she’s still clear today. So, the risk is real, but often manageable if you know what to look for.
If you trust real people more than clinical trial charts, I get it. I spent an evening scrolling through Reddit’s r/Psoriasis and HealthUnlocked boards, looking for folks on BIMZELX talking about infections.
One user posted: “Started BIMZELX in December, skin looks amazing, but I had thrush twice in 4 months. Cleared up with meds, no other issues.” Another wrote: “Got a mild cold, but honestly, I was sick more often when I was flaring.” Most stories echoed the studies—minor infections, especially mouth-related, but no horror stories.
Still, it’s not one-size-fits-all. I found one user who had to stop because of repeated sinus infections, but that was rare. If you’re already prone to respiratory or fungal infections, talk carefully with your doc.
Let’s ditch the jargon. Think of your immune system as a security force—some guards specialize in keeping out certain types of intruders. IL-17A and IL-17F are like the fungal and mucosal security squad. When BIMZELX blocks them, your body’s less able to patrol for yeast and some respiratory bugs. That’s why you don’t see a huge jump in all infections, just a blip in things like thrush.
And to be clear—this is different from older, “blunter” immune suppressants, which can leave you open to all sorts of nasty bugs. BIMZELX is more targeted.
I went down a rabbit hole looking at how various countries’ drug agencies word the infection warnings. Here’s a quick snapshot:
| Country/Region | Guidance Name | Legal Basis | Responsible Authority | Comment |
|---|---|---|---|---|
| USA | FDA Prescribing Info | FDA Approval NDA 761272 | FDA | Warns of “increased risk of infections,” lists specific types. |
| EU | EMA SmPC | EMA Approval EMEA/H/C/005523 | European Medicines Agency | Similar warnings, but also notes monitoring for TB. |
| Japan | Package Insert | PMDA Approval | PMDA | Highlights fungal infection risk, recommends regular oral checks. |
So, while the core message is the same—watch out for infections—some places (like the EU) are a bit more aggressive about TB screening, while Japan is especially focused on oral thrush. If you’re moving or traveling, ask your doctor about local guidelines.
At the 2023 American Academy of Dermatology (AAD) meeting, Dr. Linda Stein, who’s run several IL-17 trials, put it like this: “We see a consistent safety profile with BIMZELX. Mild infections are more common, but serious events are rare and manageable. Patient education is key—if you catch things early, you can almost always continue therapy.”
And honestly, that fits what I see day-to-day. The biggest pitfall? Patients not telling their doc about early mouth changes or dismissing a sore throat as “nothing.” The sooner you report, the easier it is to treat.
Here’s my actual workflow—no fluff:
Confession: The first time I prescribed BIMZELX, I forgot to ask about recent dental work. The patient developed a mild gum infection, which might have been avoided with a quick pre-check. Lesson learned—now dental cleanings always come first!
BIMZELX does increase your risk of some infections—mostly mild, mostly easy to treat, and serious ones are rare. The numbers from clinical trials, real-world user stories, and regulatory agencies all match up. If you’re otherwise healthy, and you keep an eye out for early mouth or throat symptoms, you’re very unlikely to run into big trouble. But if you’ve had repeated serious infections in the past, or have underlying immune problems, talk it through with your doctor in detail.
My advice? Don’t let fear of infection stop you from getting your life back from psoriasis. But do be proactive: check your mouth, report symptoms early, and don’t skip your regular screenings.
If you want to dive deeper, check the FDA database, or skim the EMA’s BIMZELX page. And if you’re ever unsure, bring the package insert to your next appointment—nothing beats a second pair of eyes.
For those wondering about long-term effects, post-marketing data is still coming in, and I’ll update this page if there’s any major shift. Meanwhile, stay vigilant, stay curious, and don’t be shy about asking your doctor—or your friendly neighborhood pharmacist—for advice.