Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.291
Brett King, Jennifer Soung, Christos Tziotzios, Lidia Rudnicka, Pascal Joly, Melinda Gooderham, Rodney Sinclair, Susan Anway, Dalia Wajsbrot, Alexandre Lejeune, Samuel Zwillich
{"title":"Integrated Safety Analysis of Ritlecitinib for the Treatment of Alopecia Areata (AA) From the Phase 2 and Phase 3 ALLEGRO Clinical Trial Program","authors":"Brett King, Jennifer Soung, Christos Tziotzios, Lidia Rudnicka, Pascal Joly, Melinda Gooderham, Rodney Sinclair, Susan Anway, Dalia Wajsbrot, Alexandre Lejeune, Samuel Zwillich","doi":"10.25251/skin.7.supp.291","DOIUrl":"https://doi.org/10.25251/skin.7.supp.291","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"1 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136282295","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.255
Joseph F. Merola, Lawrence Charles Parish, Lyn Guenther, Charles Lynde, Jean-Philippe Lacour, Petra Staubach, Sue Cheng, Cynthia Deignan, Mindy Chen, Kim A. Papp, Dawn Nicewarner
{"title":"Efficacy of Apremilast in Patients with Moderate-to-Severe Genital Psoriasis: Body Surface Area Subgroup Results from the Phase 3 DISCREET Trial","authors":"Joseph F. Merola, Lawrence Charles Parish, Lyn Guenther, Charles Lynde, Jean-Philippe Lacour, Petra Staubach, Sue Cheng, Cynthia Deignan, Mindy Chen, Kim A. Papp, Dawn Nicewarner","doi":"10.25251/skin.7.supp.255","DOIUrl":"https://doi.org/10.25251/skin.7.supp.255","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"63 50","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136282317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.263
Todd Schlesinger, Mark Lebwohl, James Del Rosso, Vishal A. Patel, Leon Kircik, April Armstrong, Brian Berman, Darrell Rigel, Siva Narayanan, Volker Koscielny, Ismail Kasujee, Neal Bhatia
Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional and social functioning and skin-related quality of life of patients [1]. The objective of this analysis was to evaluate safety and tolerability of tirbanibulin in AK treatment, among patients administered tirbanibulin in routine clinical practice across the U.S. Methods: A single-arm, multicenter, prospective cohort study (PROAK: NCT05260073) was conducted in adult patients with AKs on 25 cm2 on the face or scalp who were newly initiated with once-daily tirbanibulin 1% ointment treatment (5 consecutive days course) as part of usual care. Safety and tolerability endpoints were assessed at Week-8 and Week-24 and included adverse events (AEs), serious AEs (SAE), adverse drug reactions (ADRs), serious ADRs, local skin reactions (LSR), skin scarring and pigmentation (hypo/hyperpigmentation). Number of patients discontinuing treatment because of AEs, ADRs and for any other reasons were also reported. LSR (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) were scored 0-3 (absent-severe) and summed to a composite score (0-18). Results: A total of 300 patients were included in the safety analysis population (males: 68%; mean age: 67 years; Fitzpatrick skin type II: 89%; AK on the face: 78%). A total of 98% of patients completed the 5-day treatment course. During the study, 5% of patients reported at least one AE, 4% of patients at least 1 SAE, and no patients reported serious ADR. Basal Cell Carcinoma was reported in 1% of patients and Squamous Cell Carcinoma in 2% of patients; all cases were considered not related to treatment. No patients discontinued the study due to AEs or ADRs. At Week-8, the most reported LSR were erythema (48% mild-moderate, 5% severe) and flaking/scaling (50% mild-moderate, 3% severe). The rest of LSR were reported in 2-8% of patients (8% crusting, 5% swelling, 2% vesiculation/pustulation, and 2% erosion/ulceration) and all were mild-moderate in severity. Mean (min-max) LSR composite score was 0.94 (0-11). At Week-8, scarring or hypo/hyperpigmentation was observed in 1%, 5% and 3% of patients, respectively. Conclusions: Once-daily tirbanibulin 1% ointment for 5 consecutive days showed a favorable safety and tolerability profile in the treatment of AK of the face or scalp. [1] Schlesinger T et al. Skin. 2023;7(3):771-787.
{"title":"Safety and Tolerability of Tirbanibulin 1% Treatment of Actinic Keratosis on Face and Scalp in Routine Clinical Practice Across the U.S. (PROAK Study)","authors":"Todd Schlesinger, Mark Lebwohl, James Del Rosso, Vishal A. Patel, Leon Kircik, April Armstrong, Brian Berman, Darrell Rigel, Siva Narayanan, Volker Koscielny, Ismail Kasujee, Neal Bhatia","doi":"10.25251/skin.7.supp.263","DOIUrl":"https://doi.org/10.25251/skin.7.supp.263","url":null,"abstract":"Introduction: Actinic Keratosis (AK) has been shown to negatively affect emotional and social functioning and skin-related quality of life of patients [1]. The objective of this analysis was to evaluate safety and tolerability of tirbanibulin in AK treatment, among patients administered tirbanibulin in routine clinical practice across the U.S. Methods: A single-arm, multicenter, prospective cohort study (PROAK: NCT05260073) was conducted in adult patients with AKs on 25 cm2 on the face or scalp who were newly initiated with once-daily tirbanibulin 1% ointment treatment (5 consecutive days course) as part of usual care. Safety and tolerability endpoints were assessed at Week-8 and Week-24 and included adverse events (AEs), serious AEs (SAE), adverse drug reactions (ADRs), serious ADRs, local skin reactions (LSR), skin scarring and pigmentation (hypo/hyperpigmentation). Number of patients discontinuing treatment because of AEs, ADRs and for any other reasons were also reported. LSR (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) were scored 0-3 (absent-severe) and summed to a composite score (0-18). Results: A total of 300 patients were included in the safety analysis population (males: 68%; mean age: 67 years; Fitzpatrick skin type II: 89%; AK on the face: 78%). A total of 98% of patients completed the 5-day treatment course. During the study, 5% of patients reported at least one AE, 4% of patients at least 1 SAE, and no patients reported serious ADR. Basal Cell Carcinoma was reported in 1% of patients and Squamous Cell Carcinoma in 2% of patients; all cases were considered not related to treatment. No patients discontinued the study due to AEs or ADRs. At Week-8, the most reported LSR were erythema (48% mild-moderate, 5% severe) and flaking/scaling (50% mild-moderate, 3% severe). The rest of LSR were reported in 2-8% of patients (8% crusting, 5% swelling, 2% vesiculation/pustulation, and 2% erosion/ulceration) and all were mild-moderate in severity. Mean (min-max) LSR composite score was 0.94 (0-11). At Week-8, scarring or hypo/hyperpigmentation was observed in 1%, 5% and 3% of patients, respectively. Conclusions: Once-daily tirbanibulin 1% ointment for 5 consecutive days showed a favorable safety and tolerability profile in the treatment of AK of the face or scalp. [1] Schlesinger T et al. Skin. 2023;7(3):771-787.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"11 7","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136282620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.241
Howard Sofen, Bruce Strober, Shinichi Imafuku, Carle Paul, Melinda Gooderham, Lynda Spelman, Seong Jun Seo, Thierry Passeron, Renata M. Kisa, Victoria Berger, Eleni Vritzali, Kim Hoyt, Matthew J. Colombo, Subhashis Banerjee, Matthias Augustin, Linda Stein Gold, Andrew Alexis, Diamant Thaçi, Andrew Blauvelt, Mark Lebwohl
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate-to-severe plaque psoriasis, was superior to placebo and apremilast in two global, 52-week, phase 3 trials and maintained long-term efficacy through 2 years with no new safety signals in an ongoing long-term extension (LTE) trial. We report clinical efficacy for up to 3 years (148 weeks) in a subset of patients from these trials.
Materials: POETYK PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily. At Week 52, patients could enter the POETYK LTE and receive open-label deucravacitinib 6 mg QD. Deucravacitinib efficacy, as of June 15, 2022, was evaluated through Week 148 in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at Week 16 (primary endpoint) or at Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI 75, PASI 90, and sPGA 0/1 (static Physician Global Assessment of 0 [clear] or 1 [almost clear] with a ≥2-point improvement from baseline), which were reported using modified nonresponder imputation.
Results: Of patients (N=513) who completed 52 weeks in the parent trials and received continuous deucravacitinib treatment from Day 1, 313 (61.4%) achieved PASI 75 at Week 16 and 336 (66.5%) achieved PASI 75 at Week 24. Among Week 16 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (87.0%, 60.6%, and 70.8%, respectively) to Week 148 (84.5%, 60.0%, and 62.8%, respectively). Among Week 24 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (90.2%, 61.6%, and 74.1%, respectively) to Week 148 (86.0%, 60.4%, and 64.5%, respectively).
Conclusion: Clinical efficacy was maintained with continuous deucravacitinib treatment in most Week 16 and Week 24 PASI 75 responders from the parent trials through 148 weeks, supporting long-term effectiveness of once-daily oral deucravacitinib for moderate to severe plaque psoriasis.
{"title":"Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials","authors":"Howard Sofen, Bruce Strober, Shinichi Imafuku, Carle Paul, Melinda Gooderham, Lynda Spelman, Seong Jun Seo, Thierry Passeron, Renata M. Kisa, Victoria Berger, Eleni Vritzali, Kim Hoyt, Matthew J. Colombo, Subhashis Banerjee, Matthias Augustin, Linda Stein Gold, Andrew Alexis, Diamant Thaçi, Andrew Blauvelt, Mark Lebwohl","doi":"10.25251/skin.7.supp.241","DOIUrl":"https://doi.org/10.25251/skin.7.supp.241","url":null,"abstract":"Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate-to-severe plaque psoriasis, was superior to placebo and apremilast in two global, 52-week, phase 3 trials and maintained long-term efficacy through 2 years with no new safety signals in an ongoing long-term extension (LTE) trial. We report clinical efficacy for up to 3 years (148 weeks) in a subset of patients from these trials.
 Materials: POETYK PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily. At Week 52, patients could enter the POETYK LTE and receive open-label deucravacitinib 6 mg QD. Deucravacitinib efficacy, as of June 15, 2022, was evaluated through Week 148 in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at Week 16 (primary endpoint) or at Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI 75, PASI 90, and sPGA 0/1 (static Physician Global Assessment of 0 [clear] or 1 [almost clear] with a ≥2-point improvement from baseline), which were reported using modified nonresponder imputation.
 Results: Of patients (N=513) who completed 52 weeks in the parent trials and received continuous deucravacitinib treatment from Day 1, 313 (61.4%) achieved PASI 75 at Week 16 and 336 (66.5%) achieved PASI 75 at Week 24. Among Week 16 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (87.0%, 60.6%, and 70.8%, respectively) to Week 148 (84.5%, 60.0%, and 62.8%, respectively). Among Week 24 PASI 75 responders, PASI 75, PASI 90, and sPGA 0/1 response rates were maintained from Week 52 (90.2%, 61.6%, and 74.1%, respectively) to Week 148 (86.0%, 60.4%, and 64.5%, respectively).
 Conclusion: Clinical efficacy was maintained with continuous deucravacitinib treatment in most Week 16 and Week 24 PASI 75 responders from the parent trials through 148 weeks, supporting long-term effectiveness of once-daily oral deucravacitinib for moderate to severe plaque psoriasis.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"58 13","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136283600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.276
April Armstrong, Andreas Wollenberg, Marjolein De Bruin-Weller, Peter A. Lio, Chitra R. Natalie, Fangyi Zhao, Amber Reck Atwater, Gemma Jimenez, Chia-Yu Chu, Christian Vestergaard
{"title":"Conjunctivitis Does Not Increase With Longer Duration of Lebrikizumab Exposure in Patients With Moderate-to-Severe Atopic Dermatitis","authors":"April Armstrong, Andreas Wollenberg, Marjolein De Bruin-Weller, Peter A. Lio, Chitra R. Natalie, Fangyi Zhao, Amber Reck Atwater, Gemma Jimenez, Chia-Yu Chu, Christian Vestergaard","doi":"10.25251/skin.7.supp.276","DOIUrl":"https://doi.org/10.25251/skin.7.supp.276","url":null,"abstract":"","PeriodicalId":86868,"journal":{"name":"Skin","volume":"60 19","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136283790","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.287
Morgan McCarty
Introduction: Cutaneous lupus erythematosus (CLE) is the cutaneous form of a common autoimmune disease, lupus erythematosus, driven by a dysfunction within the adaptive and innate immune system. CLE is subcategorized further into acute, subacute and chronic disease. Here we report a case of a patient with systemic and refractory cutaneous disease with improvement in manifestations demonstrating efficacy following treatment with roflumilast cream 0.3% in a complex chronic CLE patient with uncontrolled disease, intense pruritus and scarring. Case Report: A 48-year-old Asian female with history of smoking, chronic refractory SLE since 2008 with a new onset of pruritic rash. Previous therapies including thalidomide, hydroxychloroquine, methotrexate, mycophenolate mofetil, numerous research trials, oral and intramuscular steroids that failed to control her systemic LE. A Rheumatology colleague referred the patient for new onset cutaneous manifestations. Initial presentation revealed lesions involving 2% of the occipital scalp. Pathology confirmed the diagnosis of discoid lupus. Intralesional triamcinolone , plus topical betamethasone dipropionate 0.05% twice daily (BID) and timolol 0.5% OP solution for wound healing were initiated. Fifteen months later the patient had disease progression of her CLE on to her scalp, face, legs and arms, with the chief complaint of persistent pruritus despite oral prednisone, hydroxychloroquine and thalidomide. The patient’s rheumatologist requested alternative treatment for cutaneous disease without use of long term topical high potency steroids. A second series of intralesional triamcinolone injections plus betamethasone dipropionate 0.05% BID for 3-4 weeks and titrate down to 2-3 applications per week, and addition of roflumilast cream 0.3% was initiated once daily to her face, scalp, and lower legs. On the third office visit, four weeks later, the patient reported pruritus and cutaneous manifestations in lower legs controlled and scalp and face have marked improvement. After 8 weeks on this regimen, the patient return reported that scalp and face continued to improve and disease on the legs continue to be controlled despite not using topical treatment for four weeks. Roflumilast cream 0.3% once daily was continued as monotherapy. Two months later, the patient reported that her skin was fully controlled was starting to repigment with monotherapy. Conclusions: This case report of a 48-year-old female with refractory treatment resistant chronic SLE and CLE treated with roflumilast cream 0.3%, a phosphodiesterase-4 (PDE-4) inhibitor, resulted in disease control, the symptom improvement of improved pruritus as well as repigmentation of the skin. The results observed in this patient suggest this topical intervention, if implemented at the beginning of treatment for cutaneous onset of disease, may have the potential to halt the progression of cutaneous involvement. This case report serves to highlight a promising intervent
{"title":"Treatment of Patient with Cutaneous Lupus Erythematosus with Roflumilast Cream 0.3%","authors":"Morgan McCarty","doi":"10.25251/skin.7.supp.287","DOIUrl":"https://doi.org/10.25251/skin.7.supp.287","url":null,"abstract":"Introduction: Cutaneous lupus erythematosus (CLE) is the cutaneous form of a common autoimmune disease, lupus erythematosus, driven by a dysfunction within the adaptive and innate immune system. CLE is subcategorized further into acute, subacute and chronic disease. Here we report a case of a patient with systemic and refractory cutaneous disease with improvement in manifestations demonstrating efficacy following treatment with roflumilast cream 0.3% in a complex chronic CLE patient with uncontrolled disease, intense pruritus and scarring. Case Report: A 48-year-old Asian female with history of smoking, chronic refractory SLE since 2008 with a new onset of pruritic rash. Previous therapies including thalidomide, hydroxychloroquine, methotrexate, mycophenolate mofetil, numerous research trials, oral and intramuscular steroids that failed to control her systemic LE. A Rheumatology colleague referred the patient for new onset cutaneous manifestations. Initial presentation revealed lesions involving 2% of the occipital scalp. Pathology confirmed the diagnosis of discoid lupus. Intralesional triamcinolone , plus topical betamethasone dipropionate 0.05% twice daily (BID) and timolol 0.5% OP solution for wound healing were initiated. Fifteen months later the patient had disease progression of her CLE on to her scalp, face, legs and arms, with the chief complaint of persistent pruritus despite oral prednisone, hydroxychloroquine and thalidomide. The patient’s rheumatologist requested alternative treatment for cutaneous disease without use of long term topical high potency steroids. A second series of intralesional triamcinolone injections plus betamethasone dipropionate 0.05% BID for 3-4 weeks and titrate down to 2-3 applications per week, and addition of roflumilast cream 0.3% was initiated once daily to her face, scalp, and lower legs. On the third office visit, four weeks later, the patient reported pruritus and cutaneous manifestations in lower legs controlled and scalp and face have marked improvement. After 8 weeks on this regimen, the patient return reported that scalp and face continued to improve and disease on the legs continue to be controlled despite not using topical treatment for four weeks. Roflumilast cream 0.3% once daily was continued as monotherapy. Two months later, the patient reported that her skin was fully controlled was starting to repigment with monotherapy. Conclusions: This case report of a 48-year-old female with refractory treatment resistant chronic SLE and CLE treated with roflumilast cream 0.3%, a phosphodiesterase-4 (PDE-4) inhibitor, resulted in disease control, the symptom improvement of improved pruritus as well as repigmentation of the skin. The results observed in this patient suggest this topical intervention, if implemented at the beginning of treatment for cutaneous onset of disease, may have the potential to halt the progression of cutaneous involvement. This case report serves to highlight a promising intervent","PeriodicalId":86868,"journal":{"name":"Skin","volume":"18 4","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.240
April W. Armstrong, Mark Lebwohl, Richard B. Warren, Howard Sofen, Shinichi Imafuku, Mamitaro Ohtsuki, Lynda Spelman, Thierry Passeron, Kim A. Papp, Renata M. Kisa, Victoria Berger, Eleni Vritzali, Kim Hoyt, Matthew J. Colombo, Subhashis Banerjee, Bruce Strober, Diamant Thaçi, Andrew Blauvelt
Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) parent trials in moderate to severe plaque psoriasis. The POETYK long-term extension (LTE; NCT04036435) trial enrolled patients who completed PSO-1/PSO-2. We report safety and efficacy of deucravacitinib for up to 3 years (Week 148; through cutoff 6/15/2022).
Methods: PSO-1/PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast twice daily. At Week 52, patients enrolled in the LTE received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients who received ≥1 dose of deucravacitinib using exposure-adjusted incidence rate per 100 person-years (EAIR/PY). Efficacy outcomes (≥75%/≥90% reduction from baseline in Psoriasis Area and Severity Index [PASI 75/90]; static Physician Global Assessment score of 0 [clear] or 1 [almost clear] with a ≥2-point improvement from baseline [sPGA 0/1]) were analyzed using modified nonresponder imputation (mNRI) in patients who received continuous deucravacitinib treatment from Day 1 of the parent trial and were treated in the LTE.
Results: Of 1519 patients who received ≥1 dose of deucravacitinib (3294.3 PY cumulative exposure), 513 patients received continuous deucravacitinib treatment from Day 1 in PSO-1/PSO-2 and were treated in the LTE. EAIRs/100 PY were comparable, or decreased, between the 2-year and 3-year cumulative periods, respectively, for AEs (154.4, 144.8), serious AEs (6.1, 5.5), discontinuations due to AEs (2.8, 2.4), herpes zoster (0.7, 0.6), malignancies (0.9, 0.9), major adverse cardiovascular events (0.4, 0.3), venous thromboembolism (0.1, 0.1), and deaths (0.4, 0.3). Response rates were maintained at Week 148 by mNRI (PASI 75, 73.2%; PASI 90, 48.1%; sPGA 0/1, 54.1%).
Conclusion: Deucravacitinib maintained a consistent safety profile and durable efficacy for up to 3 years.
{"title":"Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials","authors":"April W. Armstrong, Mark Lebwohl, Richard B. Warren, Howard Sofen, Shinichi Imafuku, Mamitaro Ohtsuki, Lynda Spelman, Thierry Passeron, Kim A. Papp, Renata M. Kisa, Victoria Berger, Eleni Vritzali, Kim Hoyt, Matthew J. Colombo, Subhashis Banerjee, Bruce Strober, Diamant Thaçi, Andrew Blauvelt","doi":"10.25251/skin.7.supp.240","DOIUrl":"https://doi.org/10.25251/skin.7.supp.240","url":null,"abstract":"Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in the POETYK PSO-1 (NCT03624127) and PSO-2 (NCT03611751) parent trials in moderate to severe plaque psoriasis. The POETYK long-term extension (LTE; NCT04036435) trial enrolled patients who completed PSO-1/PSO-2. We report safety and efficacy of deucravacitinib for up to 3 years (Week 148; through cutoff 6/15/2022).
 Methods: PSO-1/PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily (QD), or apremilast twice daily. At Week 52, patients enrolled in the LTE received open-label deucravacitinib 6 mg QD. Safety was evaluated in patients who received ≥1 dose of deucravacitinib using exposure-adjusted incidence rate per 100 person-years (EAIR/PY). Efficacy outcomes (≥75%/≥90% reduction from baseline in Psoriasis Area and Severity Index [PASI 75/90]; static Physician Global Assessment score of 0 [clear] or 1 [almost clear] with a ≥2-point improvement from baseline [sPGA 0/1]) were analyzed using modified nonresponder imputation (mNRI) in patients who received continuous deucravacitinib treatment from Day 1 of the parent trial and were treated in the LTE.
 Results: Of 1519 patients who received ≥1 dose of deucravacitinib (3294.3 PY cumulative exposure), 513 patients received continuous deucravacitinib treatment from Day 1 in PSO-1/PSO-2 and were treated in the LTE. EAIRs/100 PY were comparable, or decreased, between the 2-year and 3-year cumulative periods, respectively, for AEs (154.4, 144.8), serious AEs (6.1, 5.5), discontinuations due to AEs (2.8, 2.4), herpes zoster (0.7, 0.6), malignancies (0.9, 0.9), major adverse cardiovascular events (0.4, 0.3), venous thromboembolism (0.1, 0.1), and deaths (0.4, 0.3). Response rates were maintained at Week 148 by mNRI (PASI 75, 73.2%; PASI 90, 48.1%; sPGA 0/1, 54.1%).
 Conclusion: Deucravacitinib maintained a consistent safety profile and durable efficacy for up to 3 years.","PeriodicalId":86868,"journal":{"name":"Skin","volume":"17 6","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136281541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-11-13DOI: 10.25251/skin.7.supp.272
Jenny E. Murase, Monica Munera-Campos, H. Chih-ho Hong, Alain Taieb, Wen-Hung Chung, Amber Reck Atwater, Maria Jose Rueda, Jinglin Zhong, Maria Lucia Buziqui Piruzeli, Ignasi Pau-Charles, Mette Deleuran
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