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Q&A on JAK Inhibitors in AA
Expert Dermatologists Respond to Questions About JAK Inhibitor Therapy for Alopecia Areata

Released: December 05, 2023

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Key Takeaways
  • When starting JAK inhibitor therapy for alopecia areata, use a questionnaire to assess and discuss risks with the patient.
  • Consider drafting a letter template in case prior authorization is required for coverage. Support and empower patients with the tools they need to self-advocate if an appeal is required.
  • Integrate clinical trial findings when individualizing therapy to increase likelihood of therapy success.

In this commentary, Maryanne Senna, MD, FAAD, and Britt Craiglow, MD, answer audience questions from the recent Clinical Care Options webinar series titled, “JAK Inhibitor Therapy for Alopecia Areata: Expert Guidance to Fill in the Gaps.” You can also read their recommendations on integrating JAK inhibitors into therapy for alopecia areata (AA).

How do you discuss the safety of JAK inhibitor therapy, including adverse events (AEs), boxed warnings, and risk mitigation strategies with patients during shared decision-making?

Maryanne Senna, MD, FAAD:
I have a checklist with questions about risk factors that I print out and review with the patient. Examples include:

  • Do you have a history of any sort of malignancy?
  • Do you have uncontrolled hypertension?
  • Do you have diabetes or prediabetes?
  • Do you have a history of a myocardial infarction or heart attack?
  • To your knowledge, do you or someone in your family have any gene mutations that predispose you to malignancy?
  • Do you have a history of deep vein thrombosis (DVT) or pulmonary embolism (PE)?
  • Do you have a family history of gene mutation that predisposes you to DVT or PE?
  • Do you smoke or use tobacco products?

Once they answer the questions, we review those responses together. I then show them the data from the clinical trials on the boxed warnings and discuss the low rates of those events occurring in patients with AA on JAK inhibitors. If they do have significant risk factors, I'll discuss those specific risks with them and provide my recommendations. For example, if someone indicates they are an active smoker, “The rates of these events occurring are incredibly, incredibly low, but when they occur, they tend to happen in patients who have one or more of these risk factors.”

Britt Craiglow, MD:
In my discussions, I often reference the Oral Rheumatoid Arthritis Trial (ORAL) Surveillance study. In this study, patients with rheumatoid arthritis were treated with tofacitinib, another JAK inhibitor. Those who were over age 50 with at least 1 cardiovascular risk factor were at a slightly higher risk of AEs compared to the same patients taking TNF inhibitors. These findings led the FDA to add boxed warnings for the JAK inhibitor class.

While the data suggests the risks are lower in patients being treated for AA, it is still very important to discuss the boxed warnings and not minimize the potential risk. In general, I feel very comfortable using this class of medications in my patients, but it is important to pay attention to comorbidities that may affect one’s baseline risk.

What is your recommended baseline and follow-up monitoring when starting a JAK inhibitor?

Maryanne Senna, MD, FAAD:
At baseline, I order a complete blood count (CBC) with differential, a complete metabolic panel (CMP), fasting lipids, and screen for tuberculosis and hepatitis. Between 1 and 3 months after starting therapy, I will recheck the CBC with differential, CMP, and fasting lipids. If these results are normal and there is no dose adjustment, I repeat these once every 6 months.

Britt Craiglow, MD:
I agree. For baricitinib, I think of monitoring as I would when starting a biologic agent plus a lipid panel. Interestingly, the label does not state to check lipids at baseline, but it will be very difficult to interpret your 12-week lipids if you don't have a baseline. The lipid panel is especially important for older patients who have cardiovascular risk factors. In a patient with a concerning LDL at baseline that increases after JAK inhibitor therapy, I will likely have them discuss starting a statin with their primary care provider. Ritlecitinib does not require baseline lipids, but a CBC should be checked after 4 weeks of treatment.

Do you have any tips for getting these agents covered on insurance and successfully navigating access and coverage hurdles?

Maryanne Senna, MD, FAAD:
I've been very lucky in getting coverage for my patients with the JAK inhibitors, particularly the FDA-approved agents. In addition, the manufacturing companies offer copay assistance or bridge programs for people who have commercial insurance. In certain cases where the therapies are not covered by insurance, the companies may also help with medication assistance programs to ensure the patient will have access to therapy.

Britt Craiglow, MD:
Oftentimes, payers will use the inclusion criteria from the trials to inform their prior authorization (PA) criteria. If the PA does not get approved, you can consider appealing the decision. I have templates of appeal letters that I’ve used successfully available for when I need them. Oftentimes, the denial letter goes to the patient. To assist with the PA burden, I’ve started having patients appeal the decisions themselves; I still write a personalized letter and provide references, but patients will also write their own letter. For example, I would have a patient hand write a letter and include photos and other supporting documents, like a note from their psychologist or psychiatrist or a letter from anyone close to them, like a family member or spouse. They can express what this disease has meant for them and include that to show the human being behind the request; we’ve had a lot of success with this strategy.

What are your recommendations for treating moderate or severe AA in patients younger than 12 right now?

Britt Craiglow, MD:
I use a lot of off-label JAK inhibitors in children. My strategy is very child dependent. It is important to keep in mind we are treating the child and not ourselves or the parents. Even young children are establishing their sense of self, and they are very aware of what's going on around them. Sometimes we do make the decision to treat aggressively earlier. Soon, there will be clinical trials enrolling patients younger than 12. I always encourage people to keep an eye on clinicaltrials.gov or have their parents look there.

Beyond JAK inhibitors, I may use oral minoxidil. There is some data to suggest efficacy of dupilumab in patients with AA and atopic disease. It's not going to work for all comers, but sometimes, if they also have moderate to severe atopic disease, that's a nice option.

Is there a place in therapy for topical JAK inhibitors?

Britt Craiglow, MD:
In general, topical JAK inhibitors don’t work for AA. Ruxolitinib and delgocitinib have been studied in phase II trials and were not shown to be beneficial compared with placebo. With that being said, there may be a place off-label for these agents in a patient with limited, patchy AA or on the eyebrow regions, but we don’t have great data to support that.

How should healthcare professionals use minoxidil when combining with JAK inhibitors for AA?

Maryanne Senna, MD, FAAD:
It's rare that I don't start people on oral minoxidil at the same time we start a JAK inhibitor, simply because, from my experience, they grow hair faster and have better outcomes. Once the patient has decided they want to treat their AA, their goal is to have hair regrowth. Getting them there faster with the addition of oral minoxidil makes a lot of sense, and the side effect profile is so low that it just makes sense to get them there sooner than later.

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