\n– In the TRuE-AD3 trial, children (age \u22652 to <12 years old) with atopic dermatitis (AD) treated with ruxolitinib cream achieved significant efficacy, as defined by the Investigator\u2019s Global Assessment-treatment success (IGA-TS), following eight weeks of treatment<\/i><\/p>\n
\n– In a second study, treatment with ruxolitinib cream over eight weeks under maximum-use conditions was well tolerated in children (age \u22652 to <12 years)<\/i><\/p>\n
\n– Data were shared at the European Academy of Dermatology and Venereology (EADV) Congress 2023<\/i><\/p>\n
WILMINGTON, Del.–(BUSINESS WIRE)–$INCY<\/a>–Incyte (Nasdaq:INCY) today announced expanded results from the pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of ruxolitinib cream (Opzelura\u00ae<\/sup>) in children (age \u22652 to <12 years) with atopic dermatitis (AD), the most common type of eczema. These data were presented today in a late-breaking oral presentation (Abstract #6746; Session: D3T01.3I: Late Breaking News) at the European Academy of Dermatology and Venereology (EADV) Congress 2023, held from October 11-14 in Berlin. Additionally, results from a Phase 1 open-label maximum-use trial evaluating the safety and tolerability of ruxolitinib cream in children (age \u22652 to <12 years) treated under maximum-use conditions over an 8-week trial period were featured as an ePoster at the EADV Congress 2023.<\/p>\n \nData from the TRuE-AD3 study, which build upon previously announced<\/a> topline results, showed the study met its primary endpoint with significantly more patients treated with ruxolitinib cream (0.75% and 1.5%) achieving Investigator\u2019s Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control (non-medicated cream). IGA-TS is defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8. In addition, secondary endpoints such as time to NRS4 (\u22654-point improvement in itch Numerical Rating Scale [NRS] score) and patients demonstrating at least a 75% improvement in the Eczema Area and Severity Index (EASI75) at Week 8 were also achieved.<\/p>\n \n“The TRuE-AD3 data presented today at EADV reinforce the strong safety and efficacy profile of ruxolitinib cream and its potential to treat younger age groups,\u201d said Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity, Incyte. \u201cThere is still a significant medical need for a nonsteroidal topical treatment that provides rapid and effective control of the signs and symptoms of AD in children.\u201d<\/p>\n \nAdditional key findings from the TRuE-AD3 study include:<\/p>\n \nResults from the maximum-use trial (MUsT) in children (age \u22652 to <12 years) with at least 35% of their body surface area affected by AD showed ruxolitinib cream was well tolerated, with efficacy results consistent with data from an adolescent and adult maximum-use study and a pilot pharmacokinetics (PK)\/safety pediatric study2,3<\/sup>.<\/p>\n \nKey findings from the MUsT study include:<\/p>\n \nOpzelura is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.<\/p>\n \n\u201cAD is a chronic immune-mediated disease that impacts about 13 percent of children in the U.S., yet there remains a need for new treatment options to help this age group manage this difficult to treat skin condition,\u201d said Dr. Lawrence Eichenfield, Chief of Pediatric and Adolescent Dermatology at Rady Children\u2019s Hospital San Diego. \u201cAs a clinician, I have been extremely pleased with the results achieved by many of my adolescent and adult patients with AD prescribed ruxolitinib cream, and I am excited about the potential to have a safe, well tolerated and effective non-steroidal topical treatment option available to my pediatric patients in the future.\u201d<\/p>\n \nAD \u2013 the most common type of eczema \u2013 is a chronic skin disease, which in the U.S. affects an estimated 2-3 million patients ages 2-11 and more than 21 million people 12 years of age and older4,5<\/sup>. It is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections6<\/sup>.<\/p>\n \nMore information regarding the EADV Congress 2023 can be found at https:\/\/eadvcongress2023.org\/<\/a>.<\/p>\n \nAbout TRuE-AD3<\/b><\/p>\n \nTRuE-AD3 (NCT04921969) is a randomized, double-blind, vehicle-controlled Phase 3 study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). The study enrolled over 300 patients (age \u22652 to <12 years) diagnosed with AD for at least three months and who were candidates for topical therapy.<\/p>\n \nPatients with an Investigator\u2019s Global Assessment (IGA) score of 2 to 3 (a measure of disease severity), and with AD on 3% to 20% of their Body Surface Area (BSA; excluding scalp) were randomized 2:2:1 to receive ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; or vehicle (non-medicated cream) BID. Patients who successfully completed an efficacy assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with their same treatment group (ruxolitinib cream 0.75% or 1.5% BID). Patients initially randomized to vehicle cream were re-randomized (1:1) in a blinded manner to one of the active treatment groups.<\/p>\n \nThe primary endpoint of TRuE-AD3 is the proportion of patients achieving an Investigator\u2019s Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8. Secondary endpoints include: the proportion of patients achieving at least a 75% improvement in the Eczema Area and Severity Index (EASI75) \u2013 another measurement of disease extent and severity \u2013 the proportion of patients (age \u22656 to <12 years) with at least a 4-point improvement in the itch numerical rating scale (NRS4 at Week 8 and time to achieve NRS4). The study is also tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.<\/p>\n \nFor more information about the study, please visit https:\/\/www.clinicaltrials.gov\/study\/NCT04921969<\/a>.<\/p>\n \nAbout MUsT (NCT05034822)<\/b><\/p>\n \nThe MUsT pediatric maximum-use study (NCT05034822) is a Phase 1 open-label trial evaluating the safety, pharmacokinetics (PK), efficacy and patient-reported outcomes (PRO) of ruxolitinib cream after topical application twice daily (BID) in children over a 52-week treatment period.<\/p>\n \nChildren ages \u22652 to <12 years old with an atopic dermatitis (AD) diagnosis for ><\/span>three months, an Investigator\u2019s Global Assessment (IGA) score of 3 (moderate) or 4 (severe), with AD on \u226535% of their body surface area (BSA; excluding scalp) and with an itch Numerical Rating Scale (NRS) score of \u22654 (for patients 6 to <12 years of age) were eligible. Patients enrolled applied ruxolitinib cream 1.5% twice daily (BID) to baseline lesions for four weeks (maximum use trial period), then only to active lesions for an additional four weeks (treatment extension period), for a total treatment period of eight weeks. Eligible patients were offered the option to continue into a 44-week long-term safety (LTS) period continuing this regimen as-needed to active lesions. All study patients will have a 30-day safety follow-up visit.<\/p>\n \nThe primary outcome measure of the pediatric maximum-use study is the number of treatment emergent adverse events (TEAEs), defined as any adverse event reported for the first time or worsening of a pre-existing event after first application of ruxolitinib cream. Secondary outcome measures included concentration of ruxolitinib in plasma, steady-state plasma concentration (Css) of ruxolitinib and accumulation ratio of ruxolitinib between plasma concentrations at one hour post application.<\/p>\n \nFor more information about the study, please visit https:\/\/clinicaltrials.gov\/study\/NCT05034822<\/a>.<\/p>\n \nAbout Opzelura\u00ae<\/sup> (ruxolitinib) Cream 1.5%<\/b><\/p>\n \nOpzelura, a novel cream formulation of Incyte\u2019s selective JAK1\/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.<\/p>\n \nIn Europe, Opzelura (ruxolitinib) cream 15mg\/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.<\/p>\n \nIncyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.<\/p>\n \nOpzelura is a registered trademark of Incyte.<\/p>\n \nIMPORTANT SAFETY INFORMATION<\/b><\/p>\n \nSERIOUS INFECTIONS<\/b><\/p>\n \nPatients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:<\/b><\/p>\n \nAvoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA.<\/b><\/p>\n \nSerious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.<\/p>\n \nNo cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.<\/p>\n \nViral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.<\/p>\n \nHepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.<\/p>\n \nMORTALITY<\/b><\/p>\n \nIn a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. <\/b>Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.<\/p>\n \nMALIGNANCIES<\/b><\/p>\n \nMalignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.<\/b><\/p>\n \nConsider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.<\/p>\n \nNon-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.<\/p>\n \nMAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)<\/b><\/p>\n \nIn RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.<\/b><\/p>\n \nConsider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.<\/p>\n \nTHROMBOSIS<\/b><\/p>\n \nThromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.<\/b><\/p>\n \nThrombocytopenia, Anemia, and Neutropenia<\/b><\/p>\n \nThrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and\/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.<\/p>\n \nLipid Elevations<\/b><\/p>\n \nTreatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.<\/p>\n \nAdverse Reactions<\/b><\/p>\n \nIn nonsegmental vitiligo, the most common adverse reactions (incidence \u22651%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).<\/p>\n \nPregnancy<\/b><\/p>\n \nThere is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.<\/p>\n \nLactation<\/b><\/p>\n \nAdvise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).<\/p>\n \nPlease see <\/b>Full Prescribing Information<\/b><\/a>, including Boxed Warning, and <\/b>Medication Guide<\/b><\/a> for OPZELURA.<\/b><\/p>\n \nAbout Incyte Dermatology<\/b><\/p>\n \nIncyte\u2019s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need.<\/p>\n \nOur research and development efforts in dermatology are initially focused on leveraging our knowledge of the JAK-STAT pathway. We are exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis.<\/p>\n \nTo learn more, visit the Dermatology section<\/a> of Incyte.com<\/a>.<\/p>\n \nAbout Incyte<\/b><\/p>\n \nIncyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com<\/a> and follow @Incyte<\/a>.<\/p>\n \nForward-Looking Statements<\/b><\/p>\n \nExcept for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte\u2019s TRuE-AD3 and MUsT studies, whether or when ruxolitinib cream will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte\u2019s dermatology program generally contain predictions, estimates and other forward-looking statements.<\/p>\n \nThese forward-looking statements are based on Incyte\u2019s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA and other regulatory authorities; the efficacy or safety of Incyte\u2019s products; the acceptance of Incyte\u2019s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte\u2019s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements.<\/p>\n \n_____________________________ Contacts<\/b> <\/p>\n \nMedia<\/b>![](\"https:\/\/mms.businesswire.com\/media\/20231013777215\/en\/1078784\/21\/Incyte_Color_Logo_JPEG_2colorpos.jpg\"){kind=logo}
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5<\/sup> Data on file.
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6<\/sup> Boguniewicz M, et al. Ann Allergy Asthma Immunol.<\/i> 2018;120(1):10-22.<\/p>\n
media@incyte.com<\/a><\/p>\n