Recent Developments
Wynzora Cream Approved for Adults with Psoriasis
The FDA has approved Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) from MC2 Therapeutics for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
The approval is based on results of the US Phase 3 clinical trial against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%). The randomized trial involved 794 patients. At week 8, there was a 14.6% difference in the primary efficacy endpoint—the proportion of patients with PGA treatment success at week 8 defined as at least a 2-grade improvement from baseline in PGA to “clear” or “almost clear”—for Wynzora Cream, versus active comparator.
A higher proportion of patients achieved at least a 4-point improvement in the peak pruritus NRS score at week 4 in the Wynzora Cream group compared to vehicle.
Wynzora Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate based on PAD Technology, which uniquely enables stability of both active ingredients in an aqueous formulation.
Abbvie’s Rinvoq Meets All Endpoints in Second AD Phase 3 Study
AbbVie’s upadacitinib (Rinvoq; 15mg or 30mg, once daily) monotherapy met both primary and all secondary endpoints in Measure Up 2, the second Phase 3 study in individuals with moderate to severe atopic dermatitis. The co-primary endpoints were at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16. The Measure Up 2 study evaluated the efficacy and safety of both doses of upadacitinib monotherapy versus placebo in adolescents and adults with moderate to severe atopic dermatitis who are candidates for systemic therapy.
Significantly more patients receiving either dose of upadacitinib monotherapy showed improvement in skin clearance and reduction in itch compared to placebo at week 16. In the study, 60/73 percent of patients receiving upadacitinib 15/30 mg achieved EASI 75, respectively, versus 13 percent in the placebo group (p<0.001). Of patients treated with upadacitinib 15/30 mg, 39/52 percent achieved vIGA-AD 0/1, respectively, versus five percent of patients receiving placebo (p<0.001).
At week 16, 42/60 percent of patients on upadacitinib 15/30mg experienced clinically meaningful reductions in itch, respectively, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS) ≥4, versus 9 percent of patients receiving placebo (p<0.001). For both doses, patients experienced an early reduction in itch, which was maintained through week 16. After just one day following the first dose (day 2), reductions in itch compared to placebo were observed for patients receiving upadacitinib 30 mg (eight percent versus one percent, p<0.001).
No new safety risks were observed compared to the safety profile observed in patients with rheumatoid arthritis and psoriatic arthritis receiving Rinvoq.
Bimekizumab Bests Cosentyx in Achieving Complete Psoriasis Skin Clearance
UCB’s investigational IL-17A and IL-17F inhibitor, bimekizumab, outperformed the IL-17A inhibitor, Cosentyx (secukinumab) in a head-to-head Phase 3b study of adult patients with moderate to severe plaque psoriasis.
This is the first head-to-head study comparing anti-IL-17 treatments. BE RADIANT met its primary endpoint at week 16 with statistical significance, demonstrating complete skin clearance, as measured by a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100), for bimekizumab. The study also met all ranked secondary endpoints with statistical significance.
Bimekizumab was superior to secukinumab in achieving PASI 75 at week 4 and complete skin clearance at week 48, with both monthly (Q4 week) and bi-monthly (Q8 week) dosing. Moreover, the ongoing data assessment indicates that the safety profile of bimekizumab continues to be consistent with earlier clinical studies.
Digital Pharmacies: A Growing Option In the Face of COVID-19
As so much in life and in medicine has gone digital in the wake of the COVID-19 pandemic, so has the pharmacy. According to Medly, a full-service, digital pharmacy that offers free same-day prescription delivery, prescriptions for psoriasis are among those surging at digital pharmacies. Jitu Patel, head pharmacist and chief compliance officer of Medly, shares some insights. For his company, an app, website, text, and phone communication put patients in touch with pharmacists, as needed.
What are some of the primary benefits to patients of a digital pharmacy? Are there any drawbacks?
Mr. Patel: By leveraging technology, Medly Pharmacy offers patients an amazing customer experience while delivering better medication adherence and patient outcomes. Patients are able to receive free, same-day prescription delivery, so there is no waiting in line or having to venture out. The service also makes it easy for patients to manage their medication, with proactive refill follow-up.
One drawback may be patients who are slow to adopt new technologies. However, telehealth is a perfect example of an addition to the care continuum that is quickly becoming routine, after patients and providers began to familiarize themselves with the technology.
What are some logistical challenges to launching a digital pharmacy service?
Mr. Patel: Medly was established by second-generation pharmacy owners; our founders collectively have more than 100 years of pharmacy experience. This experience provides us with a vast amount of insight around the potential logistical challenges.
We used to have issues making same-day deliveries for distant locations. We overcame this challenge by optimizing routes and using route intelligence. The scheduling process was also enhanced and enabled us to manage same-day deliveries.
At the core of an excellent pharmacy that offers great customer experience is its operational execution. To achieve this, Medly created a curated experience that improves efficiency by benefiting all stakeholders.
Leveraging tech, distribution and bundling services such as delivery, refill management, and prior authorization coordination leads to better adherence and outcomes, which is at the core of Medly’s mission. Medly has a patient-first approach and stays hyper-focused on offering the best customer experience.
What has been the reaction to the service?
Mr. Patel: Medly fills a significant gap in healthcare which led to a great adoption of our services by physicians and patients. The reaction to digital pharmacy has been extremely positive. Patients love how convenient the service is and that it fits into their busy lives. We have received positive feedback around our customer service, which includes our free same-day delivery. From prescribing to post-prescription follow-up, we personalize the care journey so each patient receives their medication with ease.
As a specialty pharmacy, we also have positive reactions from providers. We are able to work directly with insurance companies and patients which eases the burden on the provider’s administrative staff. One challenge providers often face is medication adherence for patients. Digital pharmacies have been proven to increase patient adherence by eliminating logistical challenges and the need to remember to pick up medications.
With the current COVID-19 pandemic, people have been adapting even more to our service as it allows for both patients and providers to socially distance and isolate themselves, limiting the risk of exposure to the virus or spreading it.
How have you seen trends changing in light of the COVID-19 pandemic?
Mr. Patel: Digital pharmacies became increasingly popular prior to the COVID-19 pandemic, due to the ease of use and convenience of on-demand delivery. However, with the impact of the pandemic, including quarantine and stay-at-home orders, digital pharmacy services have seen a significant jump. All delivery services have enabled individuals to adapt to social distancing, including medication deliveries. Since medication is integral for personal health, especially for those with preexisting conditions, medication delivery services like Medly provide peace of mind for patients in the midst of the pandemic, as well as these providers.
Tremfya: First IL-23 Inhibitor Approved for PsA
FDA has approved Tremfya (guselkumab) from Janssen Pharmaceutical Companies of Johnson & Johnson for adult patients with active psoriatic arthritis (PsA). Tremfya is the first interleukin (IL)-23 approved for active PsA.
The safety and efficacy of Tremfya in PsA have been demonstrated in two pivotal Phase 3 clinical trials. DISCOVER-1 and DISCOVER-2 evaluated the efficacy and safety of Tremfya administered by subcutaneous injection in adults with active PsA compared to placebo. The results, recently published in The Lancet, showed that a significant percentage of patients treated with Tremfya reached the studies’ primary endpoint of ACR20 at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.
In addition, treatment with Tremfya improved patients’ symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index), and SF-36 Physical Component Summaryscore, and soft tissue (enthesitis and dactylitis). Tremfya also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
The overall safety profile observed in patients with PsA treated with Tremfya is generally consistent with the safety profile in patients with plaque psoriasis with the addition of bronchitis and neutrophil count decreased.
Tremfya is administered as a 100mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. Tremfya can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD (e.g., methotrexate).
CLOSE UP with Mark Lebwohl, MD
The majority of psoriasis patients are treated with topicals, including steroids, but these therapies do have their share of side effects, making compliance a challenge. This is why there’s a lot of enthusiasm about investigational once-daily roflumilast cream from Arcutis, which contains a PDE-4 inhibitor, for the topical treatment of plaque psoriasis. Mark Lebwohl, MD, Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, and colleagues recently published promising Phase 2b data on roflumilast in the New England Journal of Medicine. Practical Dermatology® magazine spoke with Dr. Lebwohl about the study’s results, the next steps and why this treatment may be a game changer for psoriasis patients.WHY IS THIS TOPIC IMPORTANT TO STUDY?
Dr. Lebwohl: Plaque psoriasis imposes a significant burden on patients and is often associated with poor quality of life. There have been many drugs approved for psoriasis but almost all have been systemic injectables or oral medications, and a large number of patients rely on topical therapy to treat their disease. This is especially challenging due to side effects, tolerability, or efficacy of existing topical treatments. Roflumilast cream could really be a game changer. Many new kinds of topicals have been introduced, most of which are just different combinations or formulas of existing treatments, but this is a whole new category. Roflumilast is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), which has been implicated in a wide range of inflammatory diseases including psoriasis and eczema. A new type of topical is needed because there are some places where we avoid using topical steroids such as the face, armpits or groin. When applied to the face, topical steroids can cause cataracts and/or perioral dermatitis and when applied to armpits, groin or under the breasts, they can cause stretch marks and cutaneous thinning.
DESCRIBE THE RESEARCH AND YOUR FINDINGS.
Dr. Lebwohl: Of 331 patients who underwent randomization in this phase 2b trial, 109 were assigned to roflumilast 0.3% cream, 113 to roflumilast 0.15% cream, and 109 to vehicle cream. Patients with plaque psoriasis who applied the topical cream once daily reported clear skin as well as improvement in itch and burden of disease, compared with their counterparts randomized to placebo. Specifically, an investigator’s global assessment (IGA) score indicating clear or almost clear at week 6 was observed in 28 percent of the patients in the roflumilast 0.3% group, in 23 percent in the roflumilast 0.15% group, and in eight percent in the vehicle group. Among the approximately 15 percent of patients overall who had baseline intertriginous psoriasis of at least mild severity, an IGA score at week 6 indicating clear or almost clear plus a 2-grade improvement in the intertriginous-area IGA score occurred in 73 percent of the patients in the roflumilast 0.3% group, 44 percent of those in the roflumilast 0.15% group, and 29 percent of those in the vehicle group.
WHAT IS THE NEXT STEP?
Dr. Lebwohl: Now, the company has to finish Phase 3 trials to confirm these Phase 2b results, and then they apply for FDA approval. If approved, this therapy can be used with other treatments including biologics. A very small group of psoriasis patients with achieve a PASI 100, even with systemic therapy, so they all have some leftover disease and still need topical therapy.
FDA Accepts Leo Pharma’s BLA for Tralokinumab for AD
FDA has accepted the Biologics License Application (BLA) for Leo Pharma’s tralokinumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD). A taget action date has been set in the second quarter of 2021.
Tralokinumab is a fully human monoclonal antibody that specifically neutralizes the interleukin-13 (IL-13) cytokine, a key driver of underlying inflammation in AD. The BLA submission is based on data from the pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies of tralokinumab.
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