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FDA Delays Review of Abrocitinib and Xeljanz

The FDA will not meet the Prescription Drug User Fee Act (PDUFA) goal dates for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis and the supplemental NDA for Xeljanz/Xeljanz XR (tofacitinib) for the treatment of adults with active ankylosing spondylitis.

The FDA cited its ongoing review of Pfizer’s post-marketing safety study, ORAL Surveillance, evaluating tofacitinib in rheumatoid arthritis patients, as a factor for the extensions.

“We remain confident in the benefit-risk profiles of abrocitinib and Xeljanz both of which have been demonstrated in robust clinical trial programs,” says Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, in a news release.

The FDA had previously extended the PDUFA goal dates to early Q3 2021.

Assessing the Risk: Biologics and Infection

A recent study published in JAMA Dermatology assessed the risk of serious infection associated with biologics and targeted therapies, such as apremilast, to treat psoriasis.

This nationwide cohort study using data from the French National Health Data System included new users of biologic agents or apremilast. Patients with HIV infection or a history of cancer, transplant, or serious infection were excluded.

A total of 44,239 new users of biologic treatment were identified. A total of 29,618 were prescribed a tumor necrosis factor inhibitor (TNF) first, 6,658 an interleukin (IL) 12/23 inhibitor, 4,093 an IL-17 inhibitor, 526 an IL-23 inhibitor, and 3,344 apremilast. The total number of serious infections was 1,656. The most frequent serious infections were gastrointestinal infections. After adjusting for time-dependent covariables, risk of serious infections was higher for new users of adalimumab or infliximab vs. etanercept. Ustekinumab was associated with a lower risk of having a serious infection. Risk of serious infections was not increased for new users of IL-17 and the IL-23 inhibitor guselkumab or apremilast vs etanercept. Risk of serious infections was increased with concomitant NSAIDs or systemic corticosteroids.

A Q&A with Alexa Kimball, MD

Alexa Kimball, MD, MPH, the CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center and a professor of dermatology at Harvard Medical School in Boston, needs no introduction. Her dedication to improving the lives of patients with all types of skin conditions including psoriasis will be recognized at the upcoming National Psoriasis Foundation’s 2021 Commit to Cure Gala in New York.

Dr. Kimball took time out of her busy schedule to talk to Practical Dermatology® magazine about how biologics have changed the landscape for psoriasis patients.

How have biologics revolutionized the treatment of these patients?

Alexa Kimball, MD, MPH: I’ve been studying psoriasis for more than 20 years and it’s been an incredible journey. When I started, we treated some patients with topical tar and light and managed them in our clinics on a daily basis. Now, we can give patients several injections over the course of the year with incredible success. It is amazing to watch them find the freedom to essentially forget that they have psoriasis. We also no longer have to manage nearly the number of hospitalizations. It’s been a remarkable transition.

With so many biologics approved for psoriasis, how do you choose?

Dr. Kimball: When I am discussing a biologic therapy with a patient, I weigh a number of factors: does he have other medical issues that make one choice better than another? Does she have psoriatic arthritis or is she thinking about becoming pregnant? Other considerations include how patients feel about the number of injections, their current occupation, their insurance coverage, and of course, what they have been on before. It’s great that we have so many options to offer people, and many are well suited for most people. That said, it does require keeping up with the literature to optimize the best matches.

Does cooling the systemic inflammation driving psoriasis with biologics stave off comorbidities?

Dr. Kimball: We’ve been very intrigued by the question of whether treating psoriasis can also positively impact other co-occurring conditions like heart disease for years. It’s challenging to demonstrate this definitively, but there is increasing evidence that biologic therapy in patients with severe psoriasis can have beneficial effects that may translate into better outcomes in conditions like heart disease.

Do barriers to access to biologics still exist?

Dr. Kimball: Barriers include insurance coverage and cost, safety concerns, and lack of access to providers that are facile with using biologics. Patient assistance programs can be helpful in some cases, and continued advocacy around cost and access is important. While there are always safety considerations, the track record of most biologics is incredibly reassuring and hasn’t changed as we have studied patients on them for years. That’s a key takeaway for patients who are considering a change. We have also done research confirming that primary care physicians influence how patients feel about the safety systemic treatment; engaging them can be a really important part of the conversation.

When do you think biosimilars will become more widely used?

Dr. Kimball: The safety and efficacy of biosimilars are generally well-established; some, like infliximab, are here and widely used already, so we hope to see them come to the US market quickly.

Any exciting biologics in the pipeline for psoriasis?

Dr. Kimball: We have reached truly remarkable achievements and are now able to clear psoriasis almost entirely for long periods of time with some biologics, and there is still development ongoing. There are still new agents undergoing testing that are not yet available in the Interleukin (IL)-17 inhibitor class and a new oral agent that inhibits Tyrosine kinase 2. I expect we will also see continued important activity in the topical and oral space.

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