Comparative study of the efficacy and safety of secukinumab vs ixekizumab in moderate‐to‐severe psoriasis after 1 year of treatment: Real‐world practice

There are no studies which directly compare efficacy in Psoriasis Area and Severity Index (PASI) response of secukinumab and ixekizumab. The main aim of this study was to compare the efficacy and safety of both drugs used to treat moderate‐to‐severe psoriasis patients over 52 weeks. Secondary objectives were to identify which factors related to prior biologic treatment influenced their efficacy and analyze data obtained at 12 weeks. A retrospective observational study was carried out, in which a group of the first 59 patients treated with secukinumab after its commercialization, was compared with another group of the first 29 patients treated with ixekizumab. The PASI 75, 90, and 100 response obtained at 52 weeks was 64.4%, 49.2%, and 41.4% for secukinumab and 75.9%, 62.1%, and 41.4% for ixekizumab, respectively, with no statistically significant differences. Regarding previous biological treatment, both treatments showed a decrease in efficacy as the number of prior biologics increases. No differences were found between secukinumab and ixekizumab in bio‐naïve or bio‐experienced patients, with the exception of a higher PASI 75 response at week 52 for ixekizumab in those patients with two or more previous biologics (P = .039) Secukinumab and ixekizumab have demonstrated high efficacy and safety, with no statistically significant differences.     

Secukinumab efficacy and safety in Japanese patients with moderate‐to‐severe plaque psoriasis: Subanalysis from ERASURE,a randomized,placebo‐controlled,phase 3 study

Secukinumab, a fully human anti‐IL‐17A monoclonal antibody, neutralizes IL‐17A, a key cytokine in the pathogenesis of psoriasis. Efficacy and safety of secukinumab was evaluated in Japanese patients with moderate‐to‐severe plaque psoriasis as part of a large Phase 3 global study (ERASURE). In this 52‐week, double‐blind study (ClinicalTrials.gov Identifier: NCT01365455, JapicCTI‐111529), 87 patients from Japan (11.8% of 738 patients randomized in the overall study population) were equally randomized to receive secukinumab 300 mg or 150 mg, or placebo once weekly at baseline and at Weeks 1, 2, 3 and 4, then every 4 weeks. Co‐primary endpoints (Week 12) were ≥75% improvement in psoriasis area‐and‐severity index (PASI 75) from baseline and a score of 0 (clear) or 1 (almost clear) on a 5‐point Investigator's Global Assessment scale (IGA mod 2011 0/1) versus placebo. PASI 75 and IGA mod 2011 0/1 responses at Week 12 were superior with secukinumab 300 mg (82.8% and 55.2%, respectively) or 150 mg (86.2% and 55.2%, respectively) versus placebo (6.9% and 3.4%, respectively; P < 0.0001 for all). Greater than 90% improvement in PASI (PASI 90) was also superior with secukinumab 300 mg (62.1%) or 150 mg (55.2%) versus placebo (0.0%) at Week 12 (P < 0.0001 for both). Clinical responses were sustained up to Week 52 in the majority of patients. During a 12‐week induction period, adverse event incidences were 48.3% with secukinumab 300 mg, 55.2% with 150 mg, and 41.4% with placebo. Secukinumab showed robust and sustainable efficacy in symptom reduction for moderate‐to‐severe plaque psoriasis in the Japanese patients.     

Effectiveness and safety of secukinumab in 69 patients with moderate to severe plaque psoriasis: A retrospective multicenter study

Secukinumab (anti‐IL17A) is effective as treatment for moderate to severe plaque psoriasis, but real‐life data on effectiveness and safety lack. We aimed to present real‐life data of all Danish patients treated with secukinumab (n = 69). At baseline, before initiation of treatment with secukinumab 300 mg (47.8%) or off‐label treatment with secukinumab 150 mg (52.2%), the median PASI score was 7.1. A total of 66.7% (34/51) and 52.9% (27/51) of patients still on secukinumab at week 12 achieved a PASI (Psoriasis Area and Severity Index)‐50 and PASI‐75 of 66.7% and 52.9%, respectively. A total of 83.0% (44/53) and 60.4% (32/53) of the patients had a PASI‐score < 5 and PASI‐score < 2, respectively, after 12 weeks on treatment with secukinumab. A third of the patients had secukinumab discontinued due to limited clinical improvement or adverse events (n = 23) within a median of 92 days (interquartile range 51–212 days). Notably, the majority of the patients may represent a particularly difficult‐to‐treat group of patients, as 92.8% had been refractory to other biologic treatment. A total of 26.1% (n = 18) experienced adverse events. Secukinumab appears to be an effective treatment option with a favorable side effect profile in patients with plaque psoriasis who are refractory to or have side effects of traditional biologic drugs.     

Efficacy and safety of secukinumab in patients with generalized pustular psoriasis: A 52‐week analysis from phase III open‐label multicenter Japanese study

Generalized pustular psoriasis (GPP) is a severe inflammatory skin disease characterized by the presence of sterile pustules covering almost the entire body and systemic symptoms such as fever. Secukinumab, a fully human‐recombinant anti‐interleukin‐17A monoclonal antibody was indicated for psoriasis vulgaris and psoriatic arthritis in Japan but is not yet investigated for GPP. In this phase III, open‐label multicenter single arm study, the efficacy and safety of secukinumab as monotherapy or with co‐medication was evaluated in 12 Japanese patients with GPP. All the patients received secukinumab 150 mg s.c. at baseline, week 1, 2, 3 and 4, and then every 4 weeks. Two non‐responders were up‐titrated to 300 mg. Change in GPP severity from baseline was evaluated by clinical global impression (CGI) categorized as “worsened”, “no change”, “minimally improved”, “much improved” or “very much improved”. Treatment success was achieved by 83.3% (n = 10) of patients at week 16 (primary end‐point) with CGI evaluated as “very much improved” (n = 9) and “much improved” (n = 1). Moreover, the area of erythema with pustules improved as early as week 1 and resolved by week 16 in most of the patients. The improvements were sustained throughout 52 weeks. Over the 52‐week treatment period, secukinumab was well tolerated with no unexpected safety signals. Nasopharyngitis, urticaria, diabetes mellitus and arthralgia were the frequent adverse events reported. The data from this study shows that secukinumab can become one of the potent treatment options for GPP.     

司库奇尤单抗治疗中重度斑块状银屑病20例临床观察

目的:观察司库奇尤单抗注射液治疗中重度斑块状银屑病的临床疗效及安全性.方法:纳入20例中重度斑块状银屑病患者,给予司库奇尤单抗注射液皮下注射治疗,300 mg/次,分别于第0、1、2、3、4周注射1次,随后每4周1次,于第4、8、12周时记录患者银屑病皮损面积和严重度指数(PASI)、中性粒细胞和淋巴细胞比值(NLR)...     

Ixekizumab in the treatment of moderate‐to‐severe plaque psoriasis: Patient adherence,satisfaction, and preferences

Ixekizumab is a humanized monoclonal antibody that exhibits its immunomodulatory effects by binding to interleukin 17A (IL‐17A), a proinflammatory cytokine. It was approved for the treatment of plaque psoriasis by the Food and Drug Administration in 2016. Ixekizumab has demonstrated superiority in clinical trials against etanercept, with no significant difference in the side effect profile. The chronicity of psoriasis requires continual treatment to achieve disease clearance. Many factors may affect adherence to treatment including patient satisfaction, patient preferences, medication cost, and medication side effects. Limited data on patient adherence, satisfaction, and preference exists in formal literature. Often, surrogate measures must be used to extrapolate information regarding these measures. In this narrative review, we describe patient adherence, satisfaction, and preferences via both direct and surrogate measures as they relate to ixekizumab treatment for moderate‐to‐severe plaque psoriasis.     

308nm单频准分子光治疗寻常性银屑病和掌跖银屑病临床疗效观察

目的:评估308nm单频准分子光局部照射治疗寻常性银屑病和掌跖银屑病的临床疗效及安全性。方法:采用单频准分子光局部照射治疗35例寻常性银屑病和15例掌跖银屑病患者皮损,每周照射1次或2次,每2周评估疗效1次,并记录不良反应。结果:30例寻常性银屑病患者经16次照射,有效率达70%,慢性斑块型疗效较好。15例掌跖银屑病患者经25次照射,有效率为53.3%。单频准分子光局部照射主要不良反应为瘙痒,局部出现红斑,偶有水疱。结论:308nm单频准分子光局部照射治疗寻常性银屑病和掌跖银屑病见效快,疗程短,且不良反应少。     

A 308-nm monochromatic excimer light in the treatment of palmoplantar psoriasis

BACKGROUND: Various reports have shown the efficacy of narrow-band UVB (311-313 nm) and excimer laser (308 nm) in the treatment of psoriasis. OBJECTIVE: To prove the efficacy of light produced by xenon-chloride excimer at 308 nm (monochromatic excimer light, MEL) in the treatment of palmoplantar psoriasis (PP). METHODS: Fifty-four patients (29 male and 25 female) affected by PP were treated with MEL every 7-14 days. A mean number of 10 sessions was performed with an increase of the dose depending on patient's skin type and response. RESULTS: All 54 patients completed the treatment. After 4 months of MEL we observed a complete remission in 31 patients, a partial remission in 13 patients, and a moderate improvement in 10 patients. CONCLUSIONS: These results suggest that MEL can be considered as a valid therapeutic option for treatment of selected forms of PP.     

Dermoscopic clues of palmoplantar hyperkeratotic eczema and palmoplantar psoriasis: A prospective,comparative study of 90 patients

Diagnosis can be difficult in isolated palmar and plantar lesions in patients with psoriasis and eczema. The purpose of our study is to compare the dermoscopic findings in patients with palmoplantar psoriasis and palmoplantar hyperkeratotic eczema. This prospective, comparative study included 90 patients histopathologically diagnosed with eczema or psoriasis (35 psoriasis and 55 eczema). The age range was 18–75 years. The most common vessel type was dot vessel in psoriasis. Red globular ring vessels were seen in five patients with psoriasis, but not in any with eczema (P = 0.007). The most common vascular distribution pattern was regular in psoriasis (40%). Patchy vascular pattern was significant in eczema. The most common background color was light red in psoriasis (48.6%) (P < 0.001). Brownish-orange globules were observed in 25.7% of patients with eczema and 5.7% in patients with psoriasis (P = 0.02). There is only one study in the published work about dermoscopy of palmoplantar psoriasis and eczema. In our study, yellow crusts, patchy scale distribution, patchy vascular pattern, yellow scale color, dull red background color and brownish-orange globules were significant in patients with palmoplantar eczema. On the other hand, patients with psoriasis had light red background color, regular vascular distribution pattern and white scale color. We observed globule structures with a pale center and dark peripheral rim only in patients with eczema, which was not identified in previous studies. This globule structure may be a new finding in eczema.     

Long‐term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3‐year results of a double‐blind extension study

Secukinumab, a fully human monoclonal antibody neutralizing interleukin‐17A, has been shown to have significant efficacy in the treatment of moderate to severe psoriasis. Long‐term (3‐year) efficacy and safety of secukinumab in Japanese patients with moderate to severe psoriasis were evaluated in an extension study of a large phase 3 global study (SCULPTURE). In the core study, 52 Japanese patients with 75% improvement of Psoriasis Area and Severity Index (PASI‐75) response at week 12 were re‐randomized to a fixed interval (FI; every 4 weeks) schedule and retreatment as needed (RAN), in which patients received placebo until start of relapse, at which time secukinumab was reinitiated. Fifty Japanese patients completed the 52‐week core study, and 47 patients entered the extension study with the same double‐blind regimens up to week 152. All patients in the secukinumab 300 mg FI and seven patients in 150 mg FI groups completed 3 years of treatment. PASI‐90 and ‐100 at the end of year 3 were achieved in 69.2% and 53.8%, respectively, in 300 mg FI and 42.9% and 42.9%, respectively, in 150 mg FI, indicating high sustained response in 300 mg FI. Mean absolute PASI was continually low in 300 mg FI and numerically higher in 150 mg FI. Dermatology Life Quality Index of 0/1 was maintained by approximately two‐thirds of 300 mg FI patients, and all EuroQoL 5‐Dimension Health Questionnaire domain measures were also improved. FI dosing was consistently more efficacious than RAN. The safety profile of secukinumab remained favorable, with no new safety concerns identified.     

No elevated risk for depression,anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis

Eczema (also known as atopic dermatitis) is the most common inflammatory skin disease, affecting approximately 25% of children and 3‐8% of adults in the developed world. One of the key building blocks of a healthy skin barrier is a protein called filaggrin, which is defective in patients with eczema. Eczema in babies often starts on the cheeks and is associated in many cases with food allergy. In older childen and adults eczema can affect different sites. In this study McAleer and colleagues, based in Ireland, the Netherlands and the UK, aimed to learn about the normal development of the skin barrier from day 2 of life through to 6 years, looking at body sites that are particularly prone to eczema. They did a painless test called tape stripping in more than 120 babies and children which allowed them to study in detail many molecules derived from the breakdown of filaggrin as well as many other enzymes involved in processing this protein. They also looked at how strong and robust the skin surface cells were. They show that cheek skin in babies and young childen is particularly slow to mature compared to other sites. The skin at this site is low in filaggrin, has weaker skin cells and more molecules causing breakdown of the barrier compared to other sites. These findings help us understand why eczema often starts on the cheeks in babies. The authors suggest that this vulnerable site may also be important for the development of food allergies in babies.     

Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis,erythrodermic psoriasis and generalized pustular psoriasis: Results from a 52‐week,open‐label,phase 3 study (UNCOVER‐J)

Psoriasis, a chronic, immune‐mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open‐label study was to evaluate the long‐term efficacy and safety of ixekizumab, a humanized, anti‐interleukin‐17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks). At week 52, 92.3% of patients with plaque psoriasis achieved Psoriasis Area and Severity Index (PASI) 75, 80.8% achieved PASI 90, 48.7% achieved PASI 100, and 52.6% had remission of plaques (by static Physician Global Assessment, sPGA [0]). Difficult to treat areas of psoriasis (nail or scalp) also responded to ixekizumab. All patients with psoriatic arthritis who were assessed (5/5) achieved an American College of Rheumatology 20 response. Most patients with erythrodermic psoriasis or generalized pustular psoriasis responded to ixekizumab and the clinical outcome was maintained over 52 weeks (75% and 60% of patients achieved sPGA [0, 1] at week 52, respectively). Mostly mild or moderate treatment‐emergent adverse events were reported by 79 of 91 patients; the most common were nasopharyngitis, eczema, seborrheic dermatitis, urticaria and injection site reactions. In conclusion, 52‐week ixekizumab treatment was efficacious and well tolerated in Japanese patients with plaque psoriasis. Efficacy was also observed in patients with erythrodermic psoriasis, generalized pustular psoriasis and psoriatic arthritis.