Baracitinib (Olumiant) vs Tofacitinib (Xeljanz) for Treating Alopecia Areata: what's better?

Baricitinib (Olumiant) vs Tofacitinib (Xeljanz) : No Comparative Data yet!

Baricitinib made headlines on June 13, 2022. It was the first FDA approved treatment for alopecia areata. Since that time, many patients and physicians have asked me if I would consider switching a patient on tofacitinib to baricitinib.

That answer is sometimes a resounding yes, but sometimes a definite no.

FDA Approval is a Medal - Not necessarily a Gold Medal

FDA approval tells us that a medication is at least reasonably safe and at least reasonably effective for the population of the United States to now proceed to think about using this medication. FDA approval does not mean a drug is entirely safe and FDA approval does not mean a drug even works all that well. FDA approval means that a drug has the green light for the company to start making the drug and doing what they want to try to get it to patients.

For baricitinib, FDA approval means the drug is viewed by the FDA as okay to use in patients with advanced alopecia areata provided patients are aware of side effects and have considered the alternatives. Baricitinib helps about 25 % of patients with advanced alopecia areata a great amount and about 1/3 of patients a pretty significant amount. 60-70 % of patients with advanced alopecia areata won’t be helped as much as they hoped for with use of baricitinib. As far as safety, issues such as infections, nausea, vomiting, blood clots, heart disease, cancer, blood test abnormalities, GI perforation, at least need to be discussed with patients. Fortunately, it seems this issues are quite uncommon in healthy patients with alopecia areata and may in fact be more common in other patient groups that use this drug (like rheumatoid arthritis patients).

Should a patient switch from tofacitinib to baricitinib?

I’m often asked if a patient who is currently using tofacitinib should switch to baricitinib. Sometimes, the answer is yes … and sometimes it’s no.

There could be reasons why switching makes sense. The main reason is drug coverage. Many insurance companies now recognize baricitinib as an FDA approved treatment and will pay for the drug. Many companies realize that tofacitinib is not FDA approved and is therefore off label. If a patient can obtained baricitinib with low cost (or not cost) but needs to pay 20,000-30000 USD out of pocket for tofacitinib, I’d say go for the low cost option.

However, one should not switch if they are hoping to switch simply with the mindset that baricitinib is better than tofacitinib.

We don’t know that. The only thing we know is that one (baricitinib) is stamped with FDA approval and has undergone fairly rigorous scrutiny. That other (tofacitinib) is not stamped with FDA approval.

We do not know if oral tofacitinib is more effective than oral baricitinib for treating alopecia areata. Similarly, we don’t know if oral tofacitinib is of similar effectiveness to baricitinib or less effective than baricitinib. Those could comparative studies just have not been done. Anywhere. Therefore I would strongly recommend that oral tofacitinib be continued if one is using it now and financial issues are not entering into the decision process.

All that we do know in 2022 is that the company that makes baricitinib has gone to the efforts to have the medication processed through the FDA for approval. It does not say anything about how effective it is compared to tofacitinib. It could be that baricitinib is more effective than tofacitinib. It could be that baricitinib is less effective than tofacitinib. It could be that someday we prove they are similarly effective. It could be that baricitinib is more effective than tofacitinib but has certain side effects which are not as good as tofacitinib. Conversely, it could be that baricitinib is less effective than tofacitinib but has certain side effects that make it a better choice compared to tofacitinib. We just don’t know.

In many counties, baracitinib and tofacitinib are not formally approved so they are all off label. That means bottles of tofacitinib and bottles of baricitinib are sitting in the pharmacy. It’s up to the physician to review what he or she feels about safety, affordability, feasability and effectiveness (the SAFE principle) in order to come up with recommendations for the patient in front of them.

Consider 3 patients with advanced alopecia areata living in countries, X, Y and Q.

In hypothetical country X, if baricitinib is $ 18,000 per year and tofacitinib is $ 9,000 per year, I’d say go with tofacitinib. There’s no reason to believe one is better than another and there is no reason to believe safety is all that different. They are just as easy to use. The SAFE principle highlights that cost is that difference.

In hypothetical country Z, if baricitinib is $ 8,000 per year and tofacitinib is $ 19,000 per year, I’d say go with baricitinib. There’s no reason to believe one is better than another and there is no reason to believe safety is all that different. They are just as easy to use. The SAFE principle highlights that cost is that difference.

In hypothetical country Q, if baricitinib is $ 18,000 per year and covered by insurance and tofacitinib is $ 9,000 per year and not covered by insurance, I’d say go with baricitinib. There’s no reason to believe one is better than another and there is no reason to believe safety is all that different. They are just as easy to use. The SAFE principle highlights that cost is that difference.

Conclusion

These are the early days of JAK inhibitors for alopecia areata. They are great options for patients with advanced forms. They do not help everyone and they are not without some risk. Fortunately, risk is relatively low and may even be lower for those who use JAK inhibitors to treat aloepcia areata compared to those who use JAK inhibitors to treat rheumatoid arthritis.

There could be a number of reasons why someone using tofacitinib might switch to baricitinib. However, switching simply with the view that baricitinib might be more effective than tofacitinib is without evidence and not backed up by any good studies that have been done to date. Similarly, switching simply with the view that baricitinib might be safer than tofacitinib is without evidence and not backed up by any good studies that have been done to date.

Cost prevails in decision making so far.