Baricitinib is a janus kinase (JAK) inhibitor already approved for the treatment of rheumatoid arthritis, COVID-19 and alopecia areata. touchIMMUNOLOGY caught up with Dr. Raj Chovatiya (Northwestern University Feinberg School of Medicine, Chicago, IL, USA) to discus the efficacy and safety profile of baricitinib in inflammatory diseases and the patients most likely to benefit from treatment with baricitinib.
‘Efficacy and safety of baricitinib for inflammatory disease.‘ was presented at AAD 2023, 17-21 March, 2023.
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Questions
- Could you give us a brief overview of the efficacy data surrounding baricitinib in inflammatory diseases? (0:17)
- What is the safety profile and potential adverse events associated with baricitinib and other JAK inhibitors? (1:18)
- Which patients are likely to benefit most from baricitinib and in whom is it contraindicated? (2:43)
Disclosures: Raj Chovatiya discloses consulting for: AbbVie, Apogee, Arcutis, Argenx, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, Galderma, Genentech, Incyte, LEO Pharma, L’Oréal, Novan, Inc., Pfizer Inc., Regeneron, Sanofi, and UCB; participating in speaker’s bureaus with: AbbVie, Arcutis, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Incyte, LEO Pharma, Novan, Inc., Pfizer Inc., Regeneron, Sanofi, and UCB.
Support: Interview and filming supported by Touch Medical Media Ltd. Interview conducted by Victoria Jones.
Filmed in coverage of the 2023 AAD Annual Meeting.
Click here for more content on dermatological conditions.
Transcript
Could you give us a brief overview of the efficacy data surrounding baricitinib in this indication? (0:17)
Baricitinib is a JAK inhibitor that actually has a few approvals. Rheumatoid arthritis is the first one that came along and it actually does have an emergency use authorization for COVID 19. But the most recent approval that we actually saw was for alopecia areata and as a JAK inhibitor, baricitinib actually works quite well at two different doses 4 milligrams and 2 milligrams for alopecia areata. In the trials that were designed, the BRAVE AA-1 and -2, phase III, parallel, randomized controlled trials, what was found is anywhere from about 35 to, let’s say, close to 40% of individuals treated with the 4 milligram dose of baricitinib at around week 36 achieved SALT score, which is a measurement that we use in alopecia, at less than or equal to 20, essentially indicating that they actually had significant regrowth of hair for the two milligram dose, maybe around, let’s say 20% to 25% in that range of individuals actually got to that same endpoint as well.
What is the safety profile and potential adverse events associated with baricitinib and other JAK inhibitors? (1:18)
When it comes to JAK inhibitors, one of the big questions always surrounding their use in any type of medicine, dermatology or otherwise is safety. And a lot of that comes from long term studies. Taking a look at tofacitinib, a different JAK inhibitor in individuals with rheumatoid arthritis. So all JAK inhibitors, whether they’re topical or oral, carry what’s called a boxed Warning, essentially highlighting the potential risk of certain side effects that were seen in the study of a different JAK inhibitor in a different disease state. So some of those bold words that you see on the label include infections, venous thromboembolic events, major adverse cardiovascular events, malignancy and even death. Now, when you actually take a look at the baricitinib clinical trials, what you find are the most common things that were seen in the placebo controlled period include upper respiratory tract infection, headache, nasopharyngitis. These were actually seen pretty similar to the placebo group. And then the ones that maybe show perhaps a little bit of increase with baricitinib treatment, acne, urinary tract infection, blood creatinine kinase increase as well. In terms of the most worrisome side effects that you theoretically may wonder about. Infection rates were quite low, particularly serious infections comparable to the placebo group and really not much going on in the way of venous thromboembolic events. Rare reports of latency in MACE that it doesn’t clear if they’re actually related to treatment.
Which patients are likely to benefit most from baricitinib and in whom is it contraindicated? (2:43)
Baricitinib was studied in a population of individuals that had severe or very severe alopecia areata. So essentially you’re going to be thinking about those individuals that have perhaps 50%, if not more, loss of a hair on the scalp. Additionally, it was study very closely in people that had fairly significant eyebrow and eyelash loss. So all of those are things that you’re going to be looking at for somebody that you’re treating. Now, keeping that boxed Warning in mind that we think about with JAK inhibitors, perhaps you may want to give a little more close thought when thinking about somebody that has a high risk for concurrent malignancy or infection before actually treating as well.
Subtitles and transcript are autogenerated.
