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Objective To study the efficacy and safety of secukinumab in the treatment of moderate and severe plaque psoriasis in children. Methods A total of 10 children with psoriasis were enrolled at Yongcheng Central Hospital from November 2021 to November 2022. All patients were treated with subcutaneous injection of secukinumab and followed up for 52 weeks. The psoriasis area and severity index (PASI) and childrens' dermatology life quality index(CDLQI) were evaluated, and adverse reactions were observed. Results After 4 weeks of the treatment, 8 patients achieved PASI 75, among which 7 patients achieved PASI 90 and PASI 100 was observed in 5 patients. After 8 weeks of the treatment, all 10 patients reached PASI 75, including 8 patients with PASI 100. After 12 weeks, all 10 patients achieved PASI 100. By 52 weeks, 9 patients reached PASI 75, including 8 patients with PASI 90 and 7 patients with PASI 100. After 4 weeks of the treatment, CDLQI scores were significantly decreased and declined to 0 by 52 weeks. No adverse reactions were observed in all patients. Conclusions Secukinumab can rapidly improve moderate to severe plaque psoriasis in children and exhibits long-lasting benefit. It is safe and can quickly improve the quality of life of the children.

Abstract Psoriasis is a chronic, immune-mediated, inflammatory skin disease, associated with multiple comorbidities and psychological and psychiatric disorders. The quality of life of patients with this disease is severely compromised, especially in moderate-to-severe plaque psoriasis. Secukinumab, a fully humanized monoclonal antibody, was the first anti-interleukin (IL)-17 biologic approved for treating psoriasis. Secukinumab demonstrated long-lasting efficacy and a good safety profile in individuals with plaque psoriasis, and it is associated with an improvement in health-related quality of life. While there is evidence that early treatment with systemic therapy can affect disease progression and improve long-term outcomes in other autoimmune diseases, evidence is limited in psoriasis, especially in real-world settings. This review provides an overview of studies describing the effectiveness of secukinumab in the treatment of psoriasis summarizing the literature and focusing on real-world evidence and early intervention.

Abstract Hidradenitis suppurativa is a chronic inflammatory disease of the hair follicle that affects the axillary and gluteal regions. Hidradenitis can coincide with other inflammatory diseases, such as ankylosing spondylitis. We present a patient suffering from an overlap of both conditions, who had a rapid improvement with secukinumab.

Background: Erythrodermic psoriasis (EP) is a potentially life-threatening disease, and there is currently no consensus regarding its optimal treatment. Biological drugs approved for Psoriasis Vulgaris treatment have been used as alternatives to traditional medications. Objective: To evaluate the clinical response and tolerability of anti- interleukin 17 (IL17) biologic drugs during a 2-year-follow-up. Methods: This was a retrospective prospective study. EP cases, defined as >75% body surface area involvement, in patients ≥18 years old treated with anti-IL17 for at least 6 consecutive months were enrolled and then followed until 104 weeks. Patient characteristics, overall clinical responses, Psoriasis Area Severity Index score changes, and adverse events were analyzed. Results: Sixteen patients met the criteria, of which 50% had achieved the Psoriasis Area Severity Index 100 response at week 12 and in 93.7% at week 24. In the prospective observation of the cohort, 87.5% were still in remission at week 52 and 81.25% at 104 weeks, without adverse events. The 3 patients in whom the treatment was interrupted lost efficacy and were switched to other therapies. Limitations: Only descriptive analysis was conducted due to the limited number of patients. Conclusions: A satisfactory long-term clinical response without adverse effects was observed in this case series, suggesting the interest of anti-IL17 in EP treatment.

Hongyan Tan, Bin Zhang, Xiawei Kang, Lvyao Wang, Xiao Qiu, Xiangyu Hu Department of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, 400011, People’s Republic of ChinaCorrespondence: Xiangyu Hu, Email 369930758@qq.comPurpose: At present, we have entered the era of using biological agents and small molecule targeted drugs to treat diseases. Although there have been many reports of biological agents treating pityriasis rubra pilaris recently, the clinical application of the JAK inhibitors in the treatment of pityriasis rubra pilaris has been rarely reported, and there is a lack of evidence on the safety and efficacy of these drugs. We explore the use of the JAK inhibitor tofacitinib in the treatment of pityriasis rubra pilaris with significant efficacy and no significant side effects, providing new ideas for the clinical treatment of pityriasis rubra pilaris.Methods: We cover a case of pityriasis rubra pilaris treated with the JAK inhibitor tofacitinib, which showed significant efficacy without any adverse effects.Results: This case report showed that the JAK inhibitor tofacitinib had significant clinical efficacy in the treatment of pityriasis rubra pilaris. We speculated that the treatment of pityriasis rubra pilaris with the JAK inhibitors may be related to blocking the activation of the JAK/STAT pathway, thereby blocking the high expression of cytokines IL-17, IL-12/IL-23, IL-23, TNF-α.Conclusion: The JAK inhibitor tofacitinib can become a new option for treating pityriasis rubra pilaris.Keywords: pityriasis rubra pilaris, JAK inhibitors, tofacitinib, secukinumab, ustekinumab

Abstract Introducion The concept of a window of opportunity in hidradenitis suppurativa (HS) management suggests that early initiation of biological therapy leads to better outcomes, though its timing remains uncertain. Methods We conducted a retrospective observational multicenter study, including consecutive patients with moderate to severe HS who initiated secukinumab treatment following prior failure with systemic antibiotics or adalimumab. Therapeutic burden was defined as the sum of previous systemic treatment cycles and previous major surgical interventions for HS. Patients were followed up for 24 weeks. Main outcomes were safety and effectiveness, assessed through the proportion of patients achieving HS Clinical Response (HiSCR) and a 55% reduction in International HS Severity Score System (IHS4-55). Additionally, potential predictors of response to secukinumab were studied. Analysis was performed on an intention-to-treat basis. Results A total of 67 patients (33 men, 34 women) were included, with a mean age of 41.55 (11.94) years and a mean baseline IHS4 of 17.88 (11.13). The mean therapeutic burden was 6.06 (3.49). At week 24, 10.45% (7/67) of patients experienced adverse events, with three leading to treatment discontinuation. At week 24, 41.79% (28/67) of patients achieved HiSCR, and 44.78% (30/67) of patients achieved IHS4-55. HiSCR could not be calculated in 12 patients with a baseline AN count

IL-23 is a cytokine produced by myeloid cells that drives the T helper 17 pathway and plays an essential role in the pathophysiology of plaque psoriasis. IL-23 activation initiates a cascade of cytokines subsequently inducing the expression of many psoriasis-related proteins. This study aimed to better understand the underlying mechanisms driving the differences between IL-23 and IL-17A blockade in patients with psoriasis and their implications for durability of clinical responses. Serum and/or skin biopsies were isolated from patients treated with guselkumab or secukinumab for evaluation of potential biomarkers of pharmacodynamic response to treatment. Guselkumab treatment led to significantly greater reductions of IL-17F and IL-22 serum levels than treatment with secukinumab at weeks 24 and 48, demonstrating sustained regulation of the IL-23/T helper 17 pathway. Analyses of proteomic and transcriptomic profiles of patient sera and skin biopsies demonstrated differential regulation of proteins involved in chemokine, TNF, and relevant immune signaling pathways to a greater degree with guselkumab than with secukinumab treatment. These data provide insights into the differences between the mechanisms and impact of IL-23 and IL-17A blockade in psoriasis, with implications for efficacy observations and treatment paradigms. Trial Registration: The original study was registered at ClinicalTrials.gov (NCT03090100).

Fabrizio Martora,* Maria Carmela Annunziata,* Luca Potestio, Teresa Battista, Angelo Ruggiero, Matteo Megna Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy*These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, NA, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 - 7462442, Email fabriziomartora92@libero.itAbstract: This case study outlines the management of a 24-year-old male with a history of juvenile nephronophthisis who underwent renal transplantation at age 12 and later required dialysis at 18 due to chronic rejection and hypertension. Subsequently, the patient developed severe Hidradenitis Suppurativa (HS) affecting the axillary, groin, and gluteal regions. Despite undergoing various systemic and intravenous antibiotic therapies, as well as Adalimumab treatment, the HS remained refractory. Adalimumab was discontinued due to a detected ejection fraction of 45% during cardiologic follow-up, likely due to COVID-19 related myocarditis. Following this, the patient was initiated on secukinumab therapy, initially undergoing an induction phase followed by maintenance dosing. Significant improvements were observed in quality of life, pain scores, and HS activity after 5 weeks of secukinumab therapy, with sustained benefits at the 6-month follow-up. Secukinumab was well tolerated, with no reported adverse events. This case underscores the effectiveness and safety of secukinumab as a therapeutic option for refractory HS, particularly in patients with comorbidities such as renal transplant recipients.Keywords: hidradenitis suppurativa, Adalimumab, antibiotic, Secukinumab

Objective To explore the clinical efficacy and safety of secukinumab in the treatment of childhood generalized pustular psoriasis (GPP) in order to provide a new therapeutic strategy for childhood generalized pustular psoriasis. Methods A retrospective analysis was conducted on the clinical data of 25 children with GPP treated with subcutaneous secukinumab in our department from June 2020 to June 2022. The efficacy was evaluated according to Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) scores, Generalized Pustular Psoriasis Area and Severity Index (GPPASI) scores, Children's Dermatology Life Quality Index (CDLQI) scores, and Depression Self-rating Scale for children (DSRSC) scores. The adverse reactions were also assessed. Results Following secukinumab treatments, the average time of lesion clearance was 3.36±0.99 days. Alleviations of scales and pustules were observed in majority of patients after 2-week treatment. After 28-week treatment, GPPGA score was reduced from 3.56±0.50 at baseline to 0.20±0.50, while GPPASI score was decreased from 34.83±9.24 at baseline to 0.68±1.64. Similarly, both CDLQI and DSRSC scores were decreased 14.96±4.88 to 0.40±0.64 and 11.41±2.54 to 6.64±1.80, respectively. During the course of treatment, upper respiratory tract infections and eczema were observed in 2 cases each. One case each had pain with pruritus on the injection site and headache. No other adverse events were observed. Conclusions Secukinumab is safe and can rapidly improve the erythema, scales and pustules in pediatric generalized pustular psoriasis in addition to the improvements in patients' quality of life and mental health.

Objective To observe the efficacy of secukinumab in the treatment of severe plaque psoriasis with abnormal liver function and the changes in liver function after the treatment. Methods Seven patients with severe plaque psoriasis with abnormal liver function were subcutaneously given secukinumab 300 mg/time, once-weekly from weeks 0 to 4, followed by once every 4 weeks. Routine blood test, liver and kidney functions, blood lipids and glucose were tested at weeks 1, 2, 3, and 4, and every 4 weeks thereafter until week 32. At the same time, the psoriatic lesion area and severity index (PASI), physician global assessment (PGA), and dermatology life quality index (DLQI) were recorded to assess the efficacy and safety. Results The PASI scores, PGA scores and DLQI were changed significantly from the baseline at all time points (P

Clinical observations of three patients aged 26, 43 and 37 years with severe psoriasis and psoriatic arthritis are presented. Clinical examples show the experience of effective treatment of patients with psoriasis and psoriatic arthritis using anti-cytokine therapy with an interleukin-17 inhibitor, initiated when the disease progresses. The clinical picture of the presented observations was characterized by an aggressive course of the skin and articular process, torpidity to basic therapy, despite the young age of the patients. It has been shown that the early termination of the progression of the inflammatory process in psoriasis with the use of genetically engineered biological therapy with secukinumab leads to a decrease in symptoms, both on the part of the skin and manifestations of the disease on the part of the musculoskeletal system. The high efficacy and safety of the drug allow complete control of the disease and improve the quality of life in patients suffering from severe forms of dermatosis.

Abstract Introduction This study aimed to understand treatment response dynamics, including factors associated with favorable response, among patients with moderate-to-severe psoriasis who received guselkumab, adalimumab, or secukinumab. Methods These post hoc analyses used data from the phase III clinical trials ECLIPSE and VOYAGE 1, which were conducted between September 2021 and November 2022. On the basis of absolute Psoriasis Area and Severity Index (aPASI) scores, patients were divided into short-term response types (SRT1–6, based on week 20–48 response) and long-term response types (LRT1–4, based on week 52–252 response). Response types (RTs) were based on aPASI cutoffs deemed clinically relevant by the investigators; SRT1/LRT1 were the most favorable response types. Baseline characteristics were compared across RTs, and logistic regression analyses established factors associated with SRT1/LRT1. Results Overall, 1045, 662, and 272 patients were included in the ECLIPSE short-term, VOYAGE 1 short-term, and VOYAGE 1 long-term analyses, respectively. Mean age, body mass index (BMI), baseline aPASI score, and body surface area were lower in SRT1 than SRT6. In VOYAGE 1, adalimumab treatment, high BMI, and current/former smoking status resulted in less favorable responses. In the VOYAGE 1 long-term analysis, patients in LRT4 had the highest baseline aPASI score, were older, and were more often obese compared with other LRT groups. Regression analyses showed that SRT1 (both treatments) in VOYAGE 1 and ECLIPSE, and LRT1 (guselkumab group) in the VOYAGE 1 long-term analysis, were associated with week 16 aPASI response. In VOYAGE 1, SRT1 was associated with psoriasis duration and smoking status. Conclusions Early treatment response and baseline characteristics, including smoking, psoriasis duration, and obesity, may be associated with longer-term response to biologics. Trial Registration Numbers ECLIPSE: NCT03090100, VOYAGE 1: NCT02207231.

Abstract Introduction Secukinumab is an anti-interleukin (IL)-17A monoclonal antibody indicated for multiple immunological disorders. Here, we aim to summarize secukinumab safety in clinical trials (CTs) and post-marketing setting (PMS) until 25 June 2022. Methods Adverse events (AEs) were summarized with crude reporting rate (RR) per 100 patient-years (PY) in PMS for all reported indications and with exposure-adjusted incident rates (EAIR) per 100 PY in pooled 47 CTs for approved indications. Results Secukinumab exposure totaled 1,159,260 PY in PMS and 27,765 PY in CTs. AEs were mostly (> 80%) non-serious in PMS. EAIR for serious AEs was 7.0/100 PY. Nasopharyngitis (RR 0.59/100 PY, EAIR 16.08/100 PY) and pneumonia (RR 0.14/100 PY, EAIR 0.17/100 PY) were the most common infection and serious infection, respectively. Candida infections (RR 0.20/100 PY, EAIR 2.16/100 PY) were the most common fungal infections. Inflammatory bowel disease (IBD) was observed in PMS (0.14/100 PY) and CTs (0.26/100 PY). Most (76%) patients with prior IBD did not report IBD flare during CTs. PMS monitoring identified paradoxical skin reactions including dyshidrotic eczema (RR 0.006/100 PY) and pyoderma gangrenosum (RR 0.003/100 PY). Conclusion Secukinumab safety profile with increased patient exposure remained favorable. Paradoxical skin reactions were identified in post-marketing monitoring.

Danyang Fan, Fuqiu Li, Zhe Liu, Zhanhan Tang, Sha Lv Department of Dermatology, The Second Hospital of Jilin University, Changchun, Jilin, 130000, People’s Republic of ChinaCorrespondence: Sha Lv, Department of Dermatology, The second hospital of Jilin University, Changchun, Jilin, 130000, People’s Republic of China, Email lvsha@jlu.edu.cnAbstract: Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a rare chronic inflammatory disease mainly manifested as skin and osteoarticular lesions. Herein, we describe a female patient with SAPHO syndrome exhibited paradoxical psoriasis and primary palmoplantar pustulosis (PPP) worsened during treatment with adalimumab. We then switched to secukinumab and obtained significant improvement in both skin lesions and osteoarticular pain. These findings suggest that secukinumab might be an appropriate option for patients with SAPHO syndrome who present with TNF-α-inhibitor-induced paradoxical psoriasis.Keywords: SAPHO syndrome, psoriasis, adalimumab, secukinumab

Background and objectives: Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disorder affecting 30% of psoriatic patients. Effective treatment, especially with biologics like IL-17 and TNF inhibitors, is vital for improving patient outcomes. This study aimed to compare the efficacy of secukinumab and adalimumab in PsA patients through clinical and ultrasonographic evaluations.Materials and methods: We enrolled 116 PsA patients, with 58 patients receiving secukinumab and 58 receiving adalimumab. Regular follow-ups were conducted at weeks 4, 12, 24, and 52. The primary outcome was the proportion of patients achieving at least a 20% improvement in the ACR response (ACR20) at week 12, with additional evaluations for axial arthritis, enthesitis, skin involvement, minimal disease activity, health assessment questionnaire, and ultrasound changes.Results: There was no significant difference in ACR20 response between the two groups at week 12 (OR: 0.59, 95% CI: 0.26–1.37, p = 0.22). However, secukinumab demonstrated superior efficacy in achieving Psoriasis Area and Severity Index (PASI)90 (OR: 2.25, 95%CI: 1.07–4.74, p = 0.03), while adalimumab showed better improvement in ultrasound synovitis count (β: 0.94, 95%CI: 0.09–1.79, p = 0.03) and synovitis PD signal (β: 0.20, 95%CI: 0.03–0.36, p = 0.02).Conclusions: In conclusion, both treatments were highly effective for PsA, with secukinumab being more suitable for severe skin involvement and adalimumab for significant ultrasound-confirmed synovitis.

Aim: Bullous pemphigoid induced by secukinumab in treatment of psoriasis is rare.Methods: We report a 49-year-old man with psoriasis who developed bullous pemphigoid during treatment with secukinumab.Results: Scattered tense vesicles with itching appeared all over the body after the fourth treatment. Bullous pemphigoid was confirmed by pathological examination and direct immunofluorescence. The patient was treated with topical corticosteroids, oral nicotinamide and minocycline hydrochloride. The lesions of bullous pemphigoid improved significantly after 7 days of treatment.Conclusions: Bullous pemphigoid is a rare adverse event following administration of secukinumab.

Background Biologics are essential in treating psoriasis. In recent years, the pathogenesis exploration and development of new target drugs have provided a more complete evidence-based foundation for the biological treatment of psoriasis. This study aims to use bibliometrics to analyze the research status and development trends of biologics in psoriasis.Methods The bibliometric analysis of publications related to biologics in psoriasis from 2004 to 2023 was conducted using the Web of Science Core Collection (WoSCC) database as the search data source. To perform the bibliometric analysis and create visual knowledge graphs, CiteSpace, the Bibliometrix R package, and VOSviewers were utilized.Results The study included a total of 3800 articles. The United States had the highest number of publications. The leading authors and institutions were Steven R. Feldman and the University of Manchester, respectively, in the global partnership. The cluster plot divided all keywords into 11 categories. Currently, Secukinumab and Guselkumab are representative biological agents being studied due to their considerable efficacy and long-term safety.Conclusions Targeted therapy has emerged as a significant trend in the current treatment of psoriasis. Early and active use of biologics can effectively control disease progression, prevent or delay the occurrence of comorbidities, and may even alter the natural course of psoriasis. However, further investigation is required to fully understand the specific mechanisms of psoriasis and the use of biological agents.

Fabrizio Martora, Teresa Battista,* Luca Potestio,* Antonio Portarapillo, Nello Tommasino, Matteo Megna Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy*These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 081 7462457, Fax +39 081 7462442, Email fabriziomartora92@libero.itAbstract: Managing HS has long posed a significant challenge for dermatologists. Adalimumab stands as the sole biologic drug sanctioned for HS, receiving approval in 2015 as an anti-tumor necrosis factor (TNF)-α drug. Real-life evidence over the years has debated its efficacy, suggesting a success rate hovering around 70%. However, the variability in existing treatments and the chronic-recurrent nature of the condition make its treatment and management exceedingly challenging. Hence, identifying new therapeutic targets for HS in the future becomes imperative. Recently, on October 31, 2023, the FDA approved secukinumab for moderate-severe HS, marking a significant development. There has been substantial discourse on the potential of anti-interleukin-23 drugs as new therapeutic avenues for treating HS in recent years. Here, we report a case of 17-year-old man successfully treated with Guselkumab. The results were confirmed at week 52.Keywords: hidradenitis suppurativa, anti-IL23, guselkumab, adalimumab, secukinumab

Fabrizio Martora,1 Claudio Marasca,2 Sara Cacciapuoti,1 Federica Fariello,1 Luca Potestio,1 Teresa Battista,1 Massimiliano Scalvenzi,1 Matteo Megna1 1Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 2Dermatology Unit, Medical Department, “Antonio Cardarelli” National Hospital, Naples, ItalyCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Naples, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email fabriziomartora92@libero.itBackground: The treatment of hidradenitis suppurativa (HS) has always been a real challenge for dermatologists; to date, adalimumab the only biologic drug approved for HS is adalimumab, an anti-tumor necrosis factor (TNF)-α drug, the approval of this drug dates to 2015, data provided by real life show an effectiveness rate of about 60% percent. Recently (31 October 2023) FDA approves secukinumab for moderate-severe HS. The treatment and management of HS is very challenging as available treatments are very limited and show very variable outcomes.Methods: We conducted a prospective monocentric study designed to evaluate the efficacy and safety of secukinumab treatment in HS patients in a real-life setting.Results: The initial cohort of patients recruited included 21 HS patients including 12 females and 9 males. About 57.1% of patients achieved the primary endpoint and recorded significant decrease in all the severity assessment scales (IHS4, DLQI and VAS pain scale) at week 16 and 52, when HiSCR reached 71.4%.Conclusion: The results of our study highlight that treatment with secukinumab in patients with severe HS who failed adalimumab may be a safe and effective therapeutic weapon.Keywords: hidradenitis suppurativa, secukinumab, adalimumab, treatments

Abstract Secukinumab is a monoclonal antibody used to specifically inhibit pathologic interleukin‐17 and therefore effectively manage conditions like plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. Although we know that antitumor necrosis factor molecules can cause paradoxical pustular psoriasis, a few case reports noted this reaction in patients treated with secukinumab. We report a case of a paradoxical drug reaction consisting of palmar pustular psoriasis in a female patient treated with secukinumab for spondyloarthritis.

Bowen Dai,1,2 Yanping Bai,2 HongDa Yu,1,2 Qiuchen Huang,1,2 Lei Wang2 1Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, People’s Republic of China; 2Department of Dermatology and Venerology, China-Japan Friendship Hospital, Beijing, 100029, People’s Republic of ChinaCorrespondence: Lei Wang, Department of Dermatology and Venereology, China-Japan Friendship Hospital, No. 2, Yinghua East Street, Chaoyang District, Beijing, 100029, People’s Republic of China, Email wanglei010zyy@163.comAbstract: Although psoriasis and systemic lupus erythematosus are both immune abnormalities, there are few reports on Ps combined with SLE in China and abroad. We present a case of a 23-year-old female with a 10-year history of psoriasis, who had a relapse with significant joint symptoms and a PASI score of 35.6, along with several positive antibodies, including antinuclear antibodies, elevated CRP and ESR, and was diagnosed with psoriasis and SLE. She has been treated with secukinumab 300 mg subcutaneously, improving her condition. She is currently being followed up. The PubMed, SCOPUS, and ISI Web of Science databases were thoroughly searched for English studies reporting psoriasis with systemic lupus erythematosus and treated using biologics. Three case reports/series were included after the screening. Our case report provides a reference for clinicians using secukinumab to treat psoriasis combined with SLE. However, further research is needed to determine whether it can be widely used or if there are common signaling pathways that can be interfered with the pathogenesis of the diseases.Keywords: psoriasis, systemic lupus erythematosus, secukinumab

Filomena Russo,1 Marco Galluzzo,2,3 Luca Stingeni,4 Severino Persechino,5 Leonardo Zichichi,6 Andrea Conti,7 Claudia Giofrè,8 Valentina Dini,9 Martina Vispi,10 Laura Atzori,11 Angelo Cattaneo,12 Aurora Parodi,13 Federico Bardazzi,14 Giuseppe Stinco,15 Paolo Dapavo,16 Giampiero Girolomoni,17 Maria Letizia Musumeci,18 Manuela Papini,19 Marina Venturini,20 Stefano Dastoli,21 Sergio Di Nuzzo,22 Maria Concetta Fargnoli,23 Gianluca Pagnanelli,24 Nicoletta Bernardini,25 Daniele Mario Gambini,26 Piergiorgio Malagoli,27 Carlo Mazzatenta,28 Ketty Peris,29 Iris Zalaudek,30 Gabriella Fabbrocini31 ,† Francesco Loconsole,32 Camilla Vassallo,33 Lucia Pietroleonardo,34 Francesca Prignano,35 Chiara Franchi,36 Anna Maria Offidani,37 Claudio Bonifati,38 Vito Di Lernia,39 Giovanni Gigante,40 Marta Silvia Bartezaghi,40 Matteo Franchi,41,42 Paola Ursoleo,40 Elisabetta Aloisi40 1Dermatology Section, Department of Medical, Surgical and Neurological Science, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy; 2Department of Systems Medicine, University of Rome “Tor Vergata”, Rome, Italy; 3Dermatology Unit, Fondazione Policlinico “Tor Vergata”, Rome, Italy; 4Section of Dermatology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 5Dermatology Unit, NESMOS Department, Faculty of Medicine & Psychology, Sapienza University of Rome, Sant’Andrea University Hospital, Rome, Italy; 6Unit of Dermatology, San Antonio Abate Hospital, Trapani, Italy; 7Section of Dermatology, Department of Specialized Medicine, University of Modena and Reggio Emilia, Modena, Italy; 8U.O.C. Dermatologia, A.O. Papardo, Messina, Italy; 9Section of Dermatology, Department of Medicine and Oncology, University of Pisa, Pisa, Italy; 10Dermatology Unit, Misericordia Hospital, Grosseto, Italy; 11Dermatology Unit, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; 12Dermatology Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, Italy; 13Section of Dermatology, DiSSal University of Genoa, Ospedale-Policlinico San Martino IRCCS, Genova, Italy; 14Dermatology Division, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy; 15Section of Dermatology, Department of Medicine, University of Udine, Udine, Italy; 16Section of Dermatology, Department of Medical Sciences, University of Turin, Turin, Italy; 17Section of Dermatology, Department of Medicine, University of Verona, Verona, Italy; 18Section of Dermatology, Department of Medical and Surgical Specialties, University of Catania, Catania, Italy; 19Dermatology Clinic of Terni, University of Perugia, Perugia, Italy; 20Section of Dermatology, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy; 21Department of Health Sciences, Magna Graecia University, Catanzaro, Italy; 22Department of Medicine and Surgery, University of Parma, Parma, Italy; 23Section of Dermatology, Department of Biotechnological and Applied Clinical Science, University of L’Aquila, L’Aquila, Italy; 24Department of Dermatology, Istituto Dermopatico dell’Immacolata - IRCCS, Roma, Italy; 25Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Dermatology Unit, “Daniele Innocenzi”, Asl Latina, Italy; 26Dermatology Unit, ASST Papa Giovanni XXIII Hospital, Bergamo, Italy; 27Dermatology Unit, Azienda Ospedaliera San Donato Milanese, Milan, Italy; 28Dermatology Unit, Lucca Azienda USL Toscana Nord Ovest, Pisa, Italy; 29Department of Translational Medicine and Surgery, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy; 30Department of Dermatology, University of Trieste, Trieste, Italy; 31Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 32Department of Dermatology, University of Bari, Bari, Italy; 33Institute of Dermatology, IRCCS Policlinico San Matteo Foundation and University of Pavia, Pavia, Italy; 34Dermatology Unit, Vito Fazzi Hospital, Lecce, Italy; 35Dermatology Clinic, Department of Health Sciences, University of Florence, Florence, Italy; 36Dermatology Unit, IRCCS IO Galeazzi, Milan, Italy; 37Dermatological Clinic, Polytechnic University of the Marche Region, Ancona, Italy; 38Department of Dermatology, Istituto Dermatologico San Gallicano - IRCCS, Roma, Italy; 39Dermatology Unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy; 40Novartis Farma SpA, Origgio, Italy; 41National Centre for Healthcare Research and Pharmacoepidemiology, Milan, Italy; 42Laboratory of Healthcare Research and Pharmacoepidemiology, Department of Statistics and Quantitative Methods, University of Milano Bicocca, Milan, Italy†Gabriella Fabbrocini passed away on 3 March 2023Correspondence: Filomena Russo, Dermatology Section, Department of Medical, Surgical and Neurological Science, University of Siena, S. Maria Alle Scotte Hospital, Siena, Italy, Email file.russo@libero.itPurpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks.Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts.Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6–positive and HLA-Cw6–negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLA-Cw6–positive and HLA–Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings.Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile.Keywords: psoriasis, secukinumab, real-world evidence, drug survival, SUPREME

Xiaolei Ma,1 Tianying Li,2 Gangwen Han1 1Department of Dermatology, Peking University International Hospital, Beijing, People’s Republic of China; 2Department of Pathology, Peking University International Hospital, Beijing, People’s Republic of ChinaCorrespondence: Xiaolei Ma, Peking University International Hospital, Life Park Road No. 1 Life Science Park of Zhong Guancun, Chang Ping District, Beijing, People’s Republic of China, Email superma.xiaolei@163.comAbstract: Atopic dermatitis and psoriasis are both common chronic inflammatory skin conditions that can significantly affect the quality of life for individuals affected by them. With the growing use of biologic agents, there have been remarkable clinical advancements in the treatment of these diseases. Interestingly, during biologic therapy for either condition, a phenomenon has emerged where treatment can paradoxically induce a transition to the phenotype of the other condition.We present two cases of immune drift phenomena caused by biologic agents for treating psoriasis and atopic dermatitis.The first one is a case of psoriasis lesion that developed in an old patient with AD who was treated with dupilumab for two months. The second one is a case of eczematoid lesion that developed in an adult patient with ankylosing spondylitis who was treated with Secukinumab for 1 year.Keywords: immune drift phenomena, secukinumab, dupilumab, psoriasis and atopic dermatitis

Introduction: Psoriasis is a chronic inflammatory disease with multiple skin manifestations, and in case of lesions affecting the genital area sexual health impairment and psychological distress can furthermore impair the quality of life of patients. Secukinumab is a fully humanized antagonist of IL-17A and is indicated for the treatment of moderate-to-severe psoriasis. Objectives: This study was conducted in order to gather retrospective real-world data regarding the efficacy of secukinumab in treating patients with moderate-to-severe plaque psoriasis in Greece. We included difficult-to-treat manifestations in our analysis, specifically regarding the efficacy in the genital area and on the skin folds. Methods: All adult patients receiving 300 mg of secukinumab and attending follow-up visits on a regular basis, according to routine medical practice, were included. The timeline of the study was from 2015 to 2020. Primary endpoint of the study was the percentage of patients who achieved a PASI75 response rate at week 16 and week 52 post baseline. Results: Ninety-nine patients were included in the study population. Regarding difficult-to-treat manifestations, we recorded scalp involvement in 74.74% (74/99) of our patients, genital psoriasis in 27.27% (27/99), and skin fold involvement (psoriasis inversa) in 17% (17/99). At week 16, PASI75/PASI90/PASI100 were observed in 87.5%/69.8%/49%, respectively. Treatment with secukinumab during the 208 weeks of observation did not reveal any major adverse event. Conclusion: According to our outcomes, secukinumab is an effective treatment choice for treating chronic plaque psoriasis, but additionally it can be efficacious in the subgroups of patients with difficult-to-treat manifestations.

Chen Zhang,1 Tianlun Kang,1 Tangliang Qian,1 Mingwei Ma,2 Xiujuan Hou,1,* Chen Li3,* 1Department of Rheumatology, Dongfang Hospital Beijing University of Chinese Medicine, Beijing, People’s Republic of China; 2School of Clinical Medicine, Peking Union Medical College Hospital (PUMC and CAMS), Beijing, People’s Republic of China; 3Department of Rheumatology, Fangshan Hospital Beijing University of Chinese Medicine, Beijing, People’s Republic of China*These authors contributed equally to this workCorrespondence: Xiujuan Hou, Department of Rheumatology, Dongfang Hospital Beijing University of Chinese Medicine, No. 6, Fangxing Park District 1, Fangzhuang, Fengtai District, Beijing, People’s Republic of China, Email houxiujuan2008@163.com Chen Li, Department of Rheumatology, Fangshan Hospital, Beijing University of Chinese Medicine, No. 4, Chengguan Health Road, Fangshan District, Beijing, People’s Republic of China, Email casio1981@163.comAbstract: Secukinumab, a monoclonal antibody targeting interleukin-17 (IL-17), has exhibited encouraging results in the therapeutic management of palmoplantar pustulosis (PPP). The development of alopecia areata (AA) is closely related to IL-17, and IL-17A inhibitors were considered as a potential treatment modality. Therefore, the development of AA during secukinumab treatment for PPP is a rare adverse event that has been rarely reported worldwide. Here we report a 35-year-old female patient with PPP who developed AA after completing the induction period of secukinumab treatment. Discontinuing secukinumab and initiating treatment with tofacitinib resulted in a significant improvement in both PPP and AA. The emergence of AA in this patient can be attributed to paradoxical skin reactions associated with IL-17 inhibitors. Tofacitinib appears to alleviate biologic-induced AA during PPP syndrome treatment.Keywords: alopecia areata, IL-17, secukinumab, palmoplantar pustulosis

Abstract Introduction This study assessed the cost-effectiveness of secukinumab compared with other biologics (adalimumab, infliximab, ustekinumab, ixekizumab, guselkumab, and Yisaipu [etanercept biosimilar]) for moderate-to-severe plaque psoriasis from the Chinese healthcare system perspective. Methods A decision-tree (first year)/Markov model (subsequent years), with an annual cycle, was implemented over a lifetime horizon. The Psoriasis Area and Severity Index (PASI) response rate at week 16 was used for treatment response. Efficacy inputs were obtained from a mixed-treatment comparison conducted using data from randomized controlled trials. Other clinical inputs (adverse events, dropout, and mortality rates), utility weights, and costs were derived from published literature and local Chinese sources. Both costs and outcomes were discounted at 5% per annum. Model outcomes included quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were conducted to test the robustness of results. Results For patients with moderate-to-severe psoriasis, secukinumab generated the highest QALYs (12.334) against all comparators at a lifetime cost of ¥231,477. Secukinumab dominated (higher QALYs at lower costs) all other biologics except ixekizumab in this population. Compared with secukinumab, ixekizumab incurred slightly lower costs (¥228,320) but gained lesser QALYs (12.284). Thus, secukinumab was a cost-effective treatment than ixekizumab at a willingness-to-pay (WTP) threshold of ¥257,094 per QALY gained. In the one-way sensitivity analysis, base-case results were most sensitive to changes in the PASI response at 16 weeks and year 2+ dropout rates. Conclusion Secukinumab is the most cost-effective treatment option for patients with moderate-to-severe psoriasis compared with other commonly used biologics from the Chinese healthcare system perspective.

Abstract Acrodermatitis continua of Hallopeau (ACH) is a rare variant of acral pustular psoriasis, exclusively involving the distal phalanges and nails of the hands and feet. We herein report a rare case of concurrent ACH and psoriatic arthritis sine psoriasis presenting with dactylitis. The patient was successfully treated with biologics and apremilast.

Abstract Background There is limited evidence over the real‐life secukinumab survival in psoriatic patients, especially in the long‐term bio‐naïve subjects, and to date biological treatments have been assessed in patients with a chronic and recalcitrant psoriasis. It has been hypothesised that early intensive treatment with biological therapies could decrease pathogenic tissue resident memory (TRm) cells migration and potentially modify the natural course of psoriasis and related comorbidities. Objectives To analyze long‐term secukinumab efficacy, safety and survival, and its predictive factors for psoriasis treatment determining also whether early intervention may result in better outcomes for patients. Methods Bio‐naïve psoriatic patients under treatment with secukinumab (n = 128 patients) in a daily practice setting were analyzed in a retrospective multicentric study and followed up to 8 years. Drug survival rate, efficacy, posology and safety were reported. Results The overall secukinumab survival was 81.9% for an average treatment exposure of 147.9 weeks. The approved posology was the most commonly prescribed regimen (78.7%), and 17.7% could be optimized. An absolut‐PASI ≤3 was reached by 86.6%, 82.6% and 91.7% at the weeks 48,156 and 264, respectively. The incidence of arthritis or psoriasis related comorbidities was low. The response was not influenced by weight, age (>65), gender or the presence of arthritis. No severe adverse events were reported. Conclusions In our bio‐naïve series, the high efficacy and long‐term survival rates observed and the low prevalence of arthritis and comorbidities might suggest that early intervention could contribute to modify the course of the disease, but further studies are needed.

Abstract Introduction The utilization of biologics in patients with psoriasis with latent tuberculosis infection (LTBI) has garnered significant attention. Although the tuberculosis (TB) safety profile of second-generation biologics, including secukinumab, has been partially confirmed in both clinical trials and real-world studies, the necessity for prophylactic therapy in patients with LTBI prior to administering this class of biologics remains a topic of controversy. Methods This study enrolled 62 patients with psoriasis with LTBI who underwent secukinumab with routine TB reexamination. Patients were divided into two groups based on whether they received antituberculosis therapy (ATB; n = 48) or not (NTB; n = 16). We performed a propensity score-matched (PSM) analysis between ATB and NTB subgroups and retrospectively reviewed their interferon-gamma release assays (IGRA) and radiographic results. Results No active TB case was reported on the basis of medical records and chest radiographs in either two group. Before PSM, the mean reexamining IGRA value was significantly elevated in patients who received prophylactic therapy (P = 0.00), but no significant increase was observed in patients who were not. After PSM, there was no significant IGRA value enhancement whether or not patients received prophylactic treatment. Conclusion Our data provide additional information on the safety profile of secukinumab in patients with psoriasis with LTBI. Furthermore, our presentation of the reexamined IGRA results revealed no significant elevation in the ATB or NTB group. As such, we believe further exploration is necessary to determine whether anti-TB medication is required prior to administering secukinumab.

Objective To evaluate the efficacy and safety of Secukinumab versus Adalimumab in the treatment of the moderate to severe plaque psoriasis. Methods A total of 90 patients with moderate to severe psoriasis were randomly divided into three groups: Secukinumab group (30 patients), Adalimumab (29 patients) and conventional therapy groups (31 patients). The Secukinumab and Adalimumab groups were treated with Secukinumab and Adalimumab, respectively, while conventional therapy group was treated with conventional medication (Acitretin, compound glycyrrhizic anhydride, calcipotriol and halometasone ointment). The PASI and PASI50/75/90/100 were evaluated at the 0th, 4th, 8th and 12th week of treatment. The DLQI were assessed at the 0th and 12th week. In addition, the safety was assessed after the treatment. Results ① The PASI and DLQI scores were lower and the improvement rates of PASI and DLQI were higher in both the secukinumab-and Adalimumab-treated groups than in the conventional medication-treated group after 4, 8 and 12 weeks of treatment (P0.05). ② PASI50/75/90/100 responses were similar among the three groups at the 4th week. However, PASI50/75/90/100 responses were higher in both the Secukinumab- and Adalimumab-treated groups than that in the conventional medication-treated group at the 12th week (P0.05). Conclusions Secukinumab and Adalimumab are more effective than the conventional medication for the moderate to severe plaque psoriasis. The efficacy of Secukinumab is comparable to that of Adalimumab.

Qianqian Zhou,1 Shengru Zhou,1 Huizi Xiong,1 Jianqiu Yang,1 Ziliang Yang,2 Naihui Zhou,2 Jinzhu Mao,2 Min Li1,2 1Department of Dermatology, Dushu Lake Hospital Affiliated to Soochow University (Medical Center of Soochow University, Suzhou Dushu Lake Hospital), Suzhou, People’s Republic of China; 2Department of Dermatology, The First Affiliated Hospital of Soochow University, Suzhou, People’s Republic of ChinaCorrespondence: Min Li, Department of Dermatology, Dushu Lake Hospital Affiliated to Soochow University (Medical Center of Soochow University, Suzhou Dushu Lake Hospital), No. 9, Chongwen Road, Suzhou, 215123, People’s Republic of China, Tel +86-18936140383, Email lm@suda.edu.cnIntroduction: Psoriasis is an immune-mediated chronic inflammatory skin disease. As our understanding of the pathogenesis of psoriasis has improved, biologic agents have become increasingly important in the treatment of psoriasis. However, the use of biologic agents is associated with cutaneous side effects. A new type of side effect called paradoxical reactions is an emerging threat arising from the increasing use of biologic agents.Case: Here, we present a case of paradoxical skin reactions – pyoderma gangrenosum (PG) and eczema – induced by biologic therapy. The case was successfully and eventually treated with baricitinib.Discussion: PG is a rare inflammatory disease characterised by painful and necrotic ulcerations containing neutrophils. It has been associated with autoimmune diseases such as inflammatory bowel disease (IBD). TNF (tumor necrosis factor) -α inhibitors can effectively treat refractory PG, while IL (interleukin) − 17A inhibitors may worsen IBD symptoms. The cause of PG in this case was believed to be secukinumab, not adalimumab. The patient was diagnosed with eczematous dermatitis due to TNF-α inhibitors, and baricitinib was added to treat eczematous dermatitis.Conclusion: Paradoxical reactions are unpredictable events that may occur during treatment with biologics at anytime. They need further research in order to formulate personalised treatment.Keywords: biology drugs, pyoderma gangrenosum, eczema, adalimumab, secukinumab, baricitinib

Abstract Pyoderma gangrenosum (PG) belongs to the group of classical neutrophilic dermatoses and is characterised by painful ulcerations. While the clinical features have been well described, the underlying pathological mechanisms are incompletely understood and adequate treatment remains challenging. A 63‐year‐old male patient had suffered from recalcitrant ulcerations on the back, groins and legs for over 20 years. Due to suspicion of PG, a skin biopsy of the flank was obtained, which was confirming the suspected diagnosis. Following several frustrating attempts to treat, another skin biopsy was carried out and a cytokine profile by quantitative reverse transcription polymerase chain reaction was performed. Compared to healthy skin, a notable upregulation of interleukin (IL)‐17A and IL‐8 was detected. Subsequently, treatment with the anti‐IL17 antibody secukinumab was started. After 3 months of treatment, the PG area was 0 cm2. Due to the discontinuation of the drug by the patient typical PG lesions reappeared, all of which disappeared again within a few weeks of restarting secukinumab therapy. At month 23, the PG area was again 0 cm2 and this complete response was maintained under secukinumab therapy to this day (76 months after the onset of secukinumab therapy). This case of a patient with therapy‐resistant PG and subsequent long‐term responsiveness to anti‐IL‐17 therapy supports the potential importance of the Th17 axis in PG. Collectively, treatment of PG using IL‐17 antagonists seems to be very promising.

Background Head-to-head comparisons through randomized controlled trials (RCTs) provide high-quality evidence to inform healthcare decisions. In their absence, indirect comparisons are often performed; however, evidence is limited on how valid matching-adjusted indirect comparison (MAIC)–based comparative efficacy estimates are vs. RCT-based estimates. Objectives Compare MAIC and RCT results of guselkumab vs. secukinumab and ixekizumab to provide insight into the validity of results generated using MAIC methods. Methods Previously reported results from MAICs of guselkumab vs. secukinumab and ixekizumab were compared with results from ECLIPSE and IXORA-R RCTs based on risk differences between Psoriasis Area and Severity Index (PASI) 90 response rates. Results Risk difference (95% confidence interval) in PASI 90 response rates at week 48 for guselkumab vs. secukinumab was 14.4% (9.4%; 19.4%) in ECLIPSE and 9.4% (4.7%; 14.0%) in the MAIC. The risk difference at week 24 for guselkumab vs. ixekizumab was 0.0% (−5.4%; 5.4%) in IXORA-R and 0.7% (−5.1%; 6.4%) in the MAIC. Conclusions Comparative efficacy results were consistent between MAICs and RCTs of guselkumab vs. secukinumab and ixekizumab. This analysis demonstrates that MAIC methods can provide valid relative treatment effect estimates when direct comparisons are lacking, particularly when trials with similar designs and patient populations inform the analysis.

Background Long-term real-life data on secukinumab use in psoriasis are limited. Objectives Determine the long-term effectiveness of secukinumab in moderate-to-severe psoriasis in real-life. Methods Multicenter retrospective study analyzing data from adult patients treated with secukinumab for at least 192 weeks and up to 240 weeks in Southern Italy, between 2016 and 2021. Clinical data, including concurrent comorbidities and prior treatments were collected. Effectiveness was assessed by Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), Dermatology Life Quality Index (DLQI) scores at the initiation of secukinumab and at weeks 4, 12, 24, 48, 96, 144, 192, and 240. Results Two hundred and seventy-five patients (174 males), mean age 50.80 ± 14.78 years, were included; 29.8% had an uncommon localization, 24.4% psoriatic arthritis, 71.6% comorbidities. PASI, BSA, and DLQI improved significantly from week 4 and continued to improve over time. Between weeks 24 and 240, PASI score was mild (≤10) in 97–100% of patients, 83–93% had mild affected BSA (BSA ≤ 3), and 62–90% reported no effect of psoriasis on their quality of life (DLQI 0–1). Only 2.6% of patients reported adverse events and no patient discontinued the treatment during the study period. Conclusions Secukinumab effectiveness in the long-term treatment of psoriasis is confirmed in real-world.

Purpose: There is a paucity of evidence on the impact of immune-mediated inflammatory disease (IMID) treatments on the immunogenicity of SARS-CoV-2 vaccination. The purpose of this literature review is to address the question of whether patients with IMIDs receiving secukinumab, a fully human anti–interleukin-17A monoclonal antibody, have an adequate immune response after SARS-CoV-2 vaccination. Materials and Methods: Clinical studies that evaluated the effect of secukinumab on immune responses in patients with IMIDs after SARS-CoV-2 vaccination were searched in publication databases, including Medline and Embase, until May 2022. Results: From the 53 articles identified, a total of 11 articles were included. Overall, the majority of the patients treated with secukinumab elicited an adequate immune response to SARS-CoV-2 vaccines. Patients receiving secukinumab for IMIDs developed cellular immune responses following vaccination with the BNT162b2 vaccine, and there were no significant differences in the overall humoral and cellular immune responses between patients and healthy individuals. The third dose of the BNT162b2 mRNA vaccine resulted in a positive antibody response in secukinumab-treated patients. Conclusion: The available data provide no evidence of impairment in immunological response to SARS-CoV-2 vaccines by secukinumab in patients with IMIDs.

Objective To assess the clinical efficacy and safety of cyclosporin, adalimumab and secukinumab in the treatment of nail psoriasis. Methods Ninety-one patients with nail psoriasis from our hospital were randomly divided into cyclosporin group (30 cases), adalimumab group (31 cases) and secukinumab group (30 cases). The nail psoriasis severity index (NAPSI) and dermatology life quality index (DLQI) in the three groups were compared before and after 12-and 24-week treatments. Clinical effectiveness and adverse reactions were observed. Results Before the treatment, there were no significant differences in NAPSI and DLQI scores among the three groups (P>0.05). After 12 weeks of the treatment, the NAPSIs in the adalimumab and the secukinumab groups were lower than that in cyclosporin group (32.16±13.82, 32.37±10.97 vs 42.20±16.66, P0.05). There were no significant differences in adverse reactions among the three groups (P=0.784). Conclusions Cyclosporin, secukinumab and adalimumab are effective and safe for nail psoriasis. Both secukinumab and adalimumab are more effective than cyclosporin, while the efficacies of secukinumab and adalimumab are comparable.

Marina Talamonti,1 Filomena Russo,2 Giovanna Malara,3,4 Katharina Hansel,5 Manuela Papini,6 Angelo Cattaneo,7 Aurora Parodi,8 Andrea Chiricozzi,9,10 Piergiorgio Malagoli,11 Federico Bardazzi,12 Valeria Brazzelli,13 Paolo Dapavo,14 Paolo Gisondi,15 Cristina Zane,16 Concetta Potenza,17 Franca Cantoresi,18 Maria Concetta Fargnoli,19 Sara Trevisini,20 Pina Brianti,21 Leonardo Pescitelli,22 Giovanni Gigante,23 Marta Bartezaghi,23 Luisa Caputo,23 Elisabetta Aloisi,23 Antonio Costanzo24,25 On behalf of the SUPREME Study Group1Dermatology, University of Rome Tor Vergata, Rome, Italy; 2Department of Medical, Surgical and Neurological Science, Dermatology Section, University of Siena, S. Maria alle Scotte Hospital, Siena, Italy; 3Dermatology Unit, Hospital “Bianchi Melacrino Morelli”, Reggio, Calabria, Italy; 4Department of Dermatology, Papardo Hospital, Messina, Italy; 5Section of Dermatology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 6Dermatologic Clinic of Terni, Department of Medicine and Surgery, University of Perugia, Perugia, Italy; 7U.O. Dermatologia, Fondazione IRCCS Ca’ Granda - Ospedale Maggiore Policlinico, Milano, Italy; 8Di.S.Sal. Section of Dermatology, Ospedale Policlinico San Martino, University of Genova, Genova GE, 16132, Italy; 9UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy; 10Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, Rome, Italy; 11Psocare Unit, I.R.C.C.S Policlinico San Donato, Milano, Italy; 12Dermatology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 13Dermatology, Fondazione IRCCS Policlinico San Matteo and University of Pavia, Pavia, Italy; 14Department of Biomedical Science and Human Oncology, Second Dermatologic Clinic, University of Torino, Torino, Italy; 15Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy; 16Dermatology Department, ASST Spedali Civili di Brescia, University of Brescia, Brescia, Italy; 17Dermatology Unit “Daniele Innocenzi”, Department of Medico-Surgical Sciences and Biotechnologies, Faculty of Pharmacy and Medicine, Sapienza University of Rome – Polo Pontino, Latina, Italy; 18Dermatology Unit, Department of Medicine, University of Roma, Roma, Italy; 19Dermatology, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy; 20Department of Dermatology, University of Trieste, Trieste, Italy; 21Dermatology and Cosmetology Unit - San Raffaele Hospital, Milan, Italy; 22Department of Health Sciences, Dermatology Clinic, University of Firenze, Firenze, Italy; 23Novartis Farma SpA, Origgio, Italy; 24Unit of Dermatology, IRCCS Humanitas Research Hospital, Milano, Italy; 25Department of Biomedical Sciences, Humanitas University, Milano, ItalyCorrespondence: Marina Talamonti, Dermatology-Department of Systems Medicine, University of Rome Tor Vergata, PTV – Policlinico Tor Vergata, V.le Oxford 81, Rome, 00133, Italy, Tel +39 0620902743, Fax +39 0620902742, Email talamonti.marina@gmail.comPurpose: Secukinumab is a fully human monoclonal antibody that inhibits interleukin (IL)-17A approved for the treatment of moderate to severe plaque psoriasis in adults and children. We compared the efficacy and safety of secukinumab in patients aged < 65 years (adult patients) versus patients aged ≥ 65 years (elderly patients) in a post-hoc analysis of the SUPREME study.Patients and Methods: Patients with moderate to severe plaque psoriasis received subcutaneous secukinumab 300 mg per week for the first 5 weeks, then 300 mg per month. We compared the following outcomes in patients aged ≥ 65 years vs < 65 years: baseline characteristics; PASI50/75/90/100 response rates (improvements ≥ 50%/75%/90%/100% in Psoriasis Area and Severity Index (PASI) from baseline); changes in Dermatology Life Quality Index (DLQI); Hospital Anxiety and Depression Scale (HAD-A, HAD-D) score changes; treatment-emergent adverse events (TEAEs).Results: Secukinumab was slightly less effective in elderly patients than in adult patients (response rates at week 16: PASI90, 69.4% vs 80.9%, p = 0.4528; PASI100, 44.4% vs 56.7%, p = 0.8973). Elderly and adult patients showed a similar time course of changes in absolute PASI scores. Patients aged ≥ 65 years had a statistically significantly lower improvement in quality of life (mean DLQI reduction) than patients aged < 65 years at week 16 [− 5.4 (± 4.3) vs − 8.8 (± 6.9), p = 0.0065] and at week 24 [− 5.3 (± 4.4) vs − 9.2 (± 7.1), p = 0.0038]. Secukinumab treatment resulted in comparable mean reductions in anxiety and depression scores in both cohorts at 24 weeks [HAD-A, − 1.3 (± 3.3) vs − 2.1 (± 3.8), p = 0.9004; HAD-D, − 1.0 (± 3.3) vs − 1.5 (± 3.1), p = 0.4598]. The frequency of TEAEs in the two cohorts was similar (16.7% vs 14.6%, p = 0.7391).Conclusion: Secukinumab is a valid option for the management of moderate to severe psoriasis in elderly patients.Keywords: psoriasis, biologics, interleukin-17A, secukinumab, elderly

Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a rare autoinflammatorydisorder without standardized therapy. IL-17 inhibitors have been effective in individual cases. However, some patients with SAPHO may develop psoriasiform or eczematous lesions as a paradoxical side of treatment with biologics. We describe a patient with both secukinumab-induced paradoxical skin lesions and primary SAPHO syndromefor whom tofacitinib treatment led to rapid remission. A 42-year-old man with SAPHO developed paradoxical eczematous lesionsafter 3 weeks of secukinumab treatment. He then received tofacitinib treatment, which resulted in a rapid improvement in his skin lesions and osteoarticular pain. Tofacitinib might be a good treatment option for patients with SAPHO syndrome who exhibit secukinumab -induced paradoxicalskin lesions.

Abstract Introduction Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease. Biologic drugs have a key role in the long-term anti-inflammatory treatment of moderate to severe patients due to their immunomodulatory properties. The aim of this study is to evaluate the effectiveness and safety of secukinumab in patients with moderate to severe HS after 16 weeks of treatment, and to explore potential predictors of clinical response to the drug. Methods Multicenter observational retrospective study. Patients treated with secukinumab 300 mg every 2 or 4 weeks who had completed at least 16 weeks of follow-up from nine hospitals based in southern Spain (Andalusia) were included in this study. Treatment effectiveness was assessed using the Hidradenitis Suppurativa Clinical Response (HiSCR). Information about adverse events was collected, the therapeutic burden of the patients was calculated as the summation of systemic medical treatments and surgical interventions (excluding incision and drainage) experienced until the start of secukinumab treatment. Results Forty-seven patients with severe HS were included for analysis. At week 16, 48.9% (23/47) of patients achieved HiSCR. Adverse events were present in 6.4% (3/47) of the patients. The multivariate analysis showed that female sex and, to a lesser extent, lower body mass index (BMI) and a lower therapeutic burden were potentially associated with a higher probability of HiSCR achievement. Conclusions Favorable short-term effectiveness and safety of secukinumab in the treatment of severe HS patients were observed. Female sex, lower BMI and a lower therapeutic burden may be associated with a higher probability of achieving HiSCR.

Whether response to an interleukin (IL-17) inhibitor is different in patients with previous exposure to an IL-17 inhibitor compared with patients with exposure to biologics with other cytokine targets remains to be elucidated. Therefore, the aim of this study was to assess whether previous exposure to an IL-17A inhibitor was associated with worse response than exposure to (an)other biologic(s). All patients in the DERMBIO register treated with an IL-17A inhibitor (secukinumab or ixekizumab) were included. With an absolute Psoriasis Area and Severity Index (PASI) ≤ 2 as response, the proportion of responders treated with IL-17A inhibitors was assessed in patients previously treated with another IL-17A inhibitor and compared with patients with previous exposure to (an)other biologic(s), using a χ2 test. In total, 100, 93 and 83 patients with previous exposure to an IL-17A inhibitor and 414, 372 and 314 patients with previous exposure to (an) other biologic(s) were assessed after 3, 6 and 12 months, respectively. No differences in the proportion of patients achieving PASI ≤ 2 were observed between the 2 groups after 3 months (54% vs 57%, p = 0.59), 6months (70% vs 66%, p = 0.42) and 12 months (69% vs 60%, p = 0.14). In conclusion, when treating patients with IL-17A inhibitors the cytokine target of the previous biologic does not appear to affect the response.

Fabrizio Martora, Matteo Megna,&ast; Teresa Battista,&ast; Luca Potestio,&ast; Maria Carmela Annunziata, Claudio Marasca, Alessia Villani, Gabriella Fabbrocini Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy&ast;These authors contributed equally to this workCorrespondence: Fabrizio Martora, Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, Napoli, 80131, Italy, Tel +39 - 081 – 7462457, Fax +39 - 081 – 7462442, Email fabriziomartora92@libero.itAbstract: To date, adalimumab (ADA) is the only biotechnology drug approved for the management of hidradenitis suppurativa (HS), an inflammatory skin condition. However, it quickly became apparent that the efficacy of adalimumab in daily practice was highly variable. In our review, we highlighted the current evidence from literature on the use of biologics in HS in a real-life setting, particularly adalimumab, secukinumab and ustekinumab. Data on the effectiveness and safety of biologic drugs in HS management have been analyzed. Even if the results are promising, more studies are needed. In our opinion, the armamentarium of drugs for HS management is increasing, and treatment will be based on a tailored-tail approach, minimizing the risk of adverse events. In this context, we want to point out the reported effectiveness and safety data concerning adalimumab, ustekinumab and secukinumab as well as ixekizumab.Keywords: hidradenitis suppurativa, adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, real life evidence

Abstract Introduction Psoriasis (PsO), an immune-mediated inflammatory skin disorder, has substantial negative impact on patients’ quality of life. Secukinumab, an approved treatment for moderate-to-severe plaque PsO, has an established long-term efficacy and safety profile. This study aims to provide real-world evidence of long-term effectiveness and retention rate of secukinumab in Vietnamese patients with PsO. Methods This retrospective, observational study collected medical records of adult patients with moderate-to-severe PsO receiving secukinumab treatment from Ho Chi Minh City Hospital of Dermato-Venereology. The primary objective was to evaluate secukinumab effectiveness in PsO as measured by 75% improvement in psoriasis area and severity index (PASI 75) at month 12. Secondary objectives were PASI 90/100, absolute PASI ≤ 3 and ≤ 5, Dermatology Life Quality Index (DLQI), and retention rate over 48 months. Results In total, 232 patients with moderate-to-severe PsO met inclusion criteria; 68.1% were male, with median age and age of onset of 39 and 27.5 years, respectively. Median time from onset of PsO to secukinumab treatment was 120 months, 95.3% were prior biologics/disease-modifying antirheumatic drugs naive and 41.4% received concomitant therapies for PsO; 82.3% had national insurance coverage. At month 12, 93.9% of patients achieved PASI 75 (primary endpoint); 80.2/56.9% achieved PASI 90/100; 91.4 and 84.8% patients achieved absolute PASI ≤ 5 and ≤ 3, respectively. The response was sustained over 48 months, with 91.9%/78.0%/52.0% of patients achieving PASI 75/90/100, 89.5% and 82.1% patients achieving absolute PASI ≤ 5 and ≤ 3, respectively. At month 12, 61.4% of patients achieved DLQI 0/1 which was sustained up to month 48 (69.2%). Secukinumab adherence rate of 84.9% at month 12 dropped to 34.2% at month 48. Patients receiving concomitant therapy and national insurance showed higher adherence rate. Conclusion Secukinumab demonstrated long-term effectiveness in real-world Vietnamese patients with moderate-to-severe PsO, with treatment adherence being higher in patients having concomitant therapies and national insurance.

Jian Gong,1,2,&ast; Weiwei Wu,3,&ast; Liguo Qiu,1,2 Xi Wang,1,2 Jianwei Bao,1,2 Jinjing Wang,4 Lifang Cheng,1,2 Zhiyuan Fu,1,5 Fengming Hu1,2 1Department of Integrated Traditional Chinese and Western Medicine of Dermatology, Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, People’s Republic of China; 2Jiangxi Provincial Clinical Research Center for Skin Diseases, Nanchang, Jiangxi, People’s Republic of China; 3Department of Plastic and Dermatological Surgery, The Fifth People’s Hospital of Hainan Province, Haikou, Hainan, People’s Republic of China; 4Clinical School of Medicine, Jiangxi University of Traditional Chinese Medicine, Nanchang, Jiangxi, People’s Republic of China; 5Department of Pharmacy, Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Zhiyuan Fu, Department of Pharmacy, Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, People’s Republic of China, Tel +86 13970827820, Fax +86-0791-85207512, Email 1074586168@qq.com Fengming Hu, Department of Integrated Traditional Chinese and Western Medicine of Dermatology, Dermatology Hospital of Jiangxi Province, Nanchang, Jiangxi, People’s Republic of China, Tel +86 13970935828, Fax +86-0791-85207512, Email 18970802429@163.comAbstract: Psoriasis is an immune-mediated chronic inflammatory dermatosis influenced by hereditary and environmental factors. Human immunodeficiency virus (HIV) infection affects the immune system and exacerbates psoriatic lesions. We report the case of a 33-year-old male patient diagnosed with psoriasis vulgaris, psoriatic arthritis and HIV infection. Acitretin capsules, etanercept and high-active antiretroviral therapy (HAART) were effective. Two months after etanercept was discontinued, his condition worsened. After switching to secukinumab combined with HAART, the symptoms of psoriatic arthritis resolved rapidly after four weeks, with a Disease Activity Index for Psoriatic Arthritis score of 0. The time to achieve psoriasis area and severity index 40, 75, 90, and 100 were 2, 4, 8, and 29 weeks. The treatment was maintained for 1 year with no adverse reactions. Regarding the stable CD4+ T lymphocyte count and the viral load, administering anti-IL-17 monoclonal antibodies is an effective treatment option for psoriasis patients.Keywords: psoriasis, HIV, etanercept, secukinumab, biologics

Ying Li1,2 &ast;, Jia-Jing Lu1,2 &ast;, Xiao-Yuan Zhong1,2 &ast;, Ying-Yuan Yu1,2 &ast;, Ning Yu,1,2 Yu Wang,1,2 Xue-Mei Yi,1,2 Yang-Feng Ding,1,2 Yu-Ling Shi1,2 1Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, People’s Republic of China; 2Institute of Psoriasis, Tongji University School of Medicine, Shanghai, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Yu-Ling Shi; Yang-Feng Ding, Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, 1278 Road, Shanghai, 200443, People’s Republic of China, Email shiyuling1973@tongji.edu.cn; dingyangfeng@hotmail.comBackground: Data pertaining to biologic agents used for treating psoriasis in real-world settings are lacking at present. To compare drug survival at 52 weeks for a range of biologics used to treat psoriasis under real-world conditions.Methods: This was a retrospective, single-center, observational study of a cohort of patients diagnosed with plaque psoriasis treated using ixekizumab, secukinumab, guselkumab, or adalimumab between January 2020 and December 2021. Baseline demographic characteristics, duration of psoriasis, and prior biological treatments for all patients were recorded. Drug survival rates were analyzed in different patient groups using Kaplan–Meier curves and Log rank tests.Results: In total, this study included 386 plaque psoriasis patients, of whom 70, 175, 36, and 105 were, respectively, treated using ixekizumab, secukinumab, guselkumab, and adalimumab. Over a 52-week period, the overall cumulative drug survival rates for ixekizumab, secukinumab, guselkumab, and adalimumab were 67.1%, 63.0%, 72.2%, and 37.1%, respectively. Lack of efficacy was the primary cause of discontinuation for these biologic therapies, followed by economic burden and adverse event incidence.Conclusion: These results suggest that guselkumab exhibited superior drug survival, drug survival outcomes for ixekizumab and secukinumab were comparable, and significantly better than those of adalimumab in China. Preventing a loss of drug efficacy represents a primary approach to improving biologic drug survival in psoriasis patients.Keywords: biologics, drug survival, real-world, psoriasis, ixekizumab, secukinumab, guselkumab, adalimumab

Abstract Background The Family Dermatology Life Quality Index (FDLQI) was developed to meet a need for a dermatology‐specific family member/partner quality‐of‐life (QoL) measure. This paper focuses on the analysis and interpretation of FDLQI data (used as an exploratory outcome) collected in the SIGNATURE study. Objectives To measure the impact of secukinumab therapy for moderate to severe plaque psoriasis on the QoL of family members/partners of patients. Methods Randomised, open‐label, non‐comparator study in 53 dermatology centres in the UK and Republic of Ireland. Patients received secukinumab 300 or 150 mg subcutaneously weekly for 4 weeks, then 4‐weekly. FDLQI Results Family members of PASI 75 responders and non‐responders showed improved FDLQI compared to baseline, greater for responders. There was a high level of correlation between FDLQI and Dermatology Life Quality Index (DLQI) scores and positive correlations across all mapped FDLQI and DLQI questions, and a close association between the scales at all timepoints. The estimated FDLQI scores were consistently 56% of those obtained for DLQI. There was an improvement for all FDLQI questions at Week 16 with a mean total score change of 8.2. Most family member subjects had an improved score for all FDLQI questions (75%–91%, Week 12, and 77%–91%, Week 16). Family subjects with a corresponding patient visit DLQI score >10 improved for all FDLQI questions at Week 16 (mean total score change of 5.2). Conclusions Successful therapy for severe psoriasis greatly improved QoL of family members/partners. The FDLQI questionnaire responds well and appropriately to major changes in the disease severity of those affected by plaque psoriasis.

Abstract is missing (Short communication)

Background : In recent years, use of biological therapy in psoriasis has increased as a result of advances in understanding the pathophysiology of psoriasis disease. Biological agents currently approved for the treatment of moderate to severe plaque psoriasis including inhibitor TNF-α (adalimumab, etanercept, infliximab), inhibitor IL-17 (ixekizumab, brodalumab, secukinumab), inhibitor IL-12/IL-23 (ustekinumab), and inhibitor IL-23 (guselkumab, tildrakizumab). Secukinumab is a human monoclonal antibody that selectively neutralizes IL-17A, a cytokine involved in the development of psoriasis. Review: Psoriasis is a chronic skin inflammation with the characteristic form of erythematous plaque firmly, thick scale, layered, and silvery-white. The trigger factors cause damage to the skin and produce cytokines IFN-γ, TNF-α, IL-17, and IL-22. This proinflammatory cytokine induces the proliferation of keratinocytes and subsequently causes skin inflammation, leading to plaque psoriasis formation. Biologic agents are utilized to block those cytokines. There are three main classes of biological agents in the treatment of psoriasis: inhibitor TNFα, inhibitor IL-17, and inhibitor IL-23. Secukinumab is a fully human antibody that selectively binds and neutralizes IL-17A. Conclusion: Biological agents targeting IL-17 receptors are more effective and safer than biological agents that target TNF-α and IL-23 receptors for moderate to severe plaque psoriasis treatment. Secukinumab has been approved for plaque psoriasis therapy in adults, psoriasis arthritis (PsA), and ankylosing spondylitis.