Objective: To examine the real-world effectiveness of secukinumab with regard to clinical and patient-reported outcomes (PROs) from enrollment to a 6-month follow-up visit in patients with psoriasis ...in the Corrona Psoriasis Registry.
Methods: Eligible patients aged ≥ 18 years who initiated secukinumab at enrollment in the Corrona Psoriasis Registry and had a 6-month follow-up visit (window: 5-9 months) as of December 31 2017, were included in the analysis. Measures of disease severity and PROs were assessed in patients who maintained secukinumab treatment at the 6-month follow-up visit.
Results: Of the 144 patients who initiated secukinumab at enrollment and had a 6-month follow-up visit, 118 (81.9%) maintained secukinumab treatment at 6 months and demonstrated significant improvements in affected body surface area (BSA) and 5-point Investigator's Global Assessment (IGA) score (all p < .01). The majority of patients were biologic experienced (89.8%). In addition, patients reported significant improvements in quality of life, as well as in pain, itch, fatigue, work productivity, and daily activities (all p < .01).
Conclusions: Secukinumab significantly improved disease severity and PROs after 6 months of follow-up in this real-world study, which is consistent with other current real-world studies.
Biologic therapies have dramatically changed the management of moderate to severe psoriasis; however, few US real-world studies characterize the unmet needs of patients who do not respond to biologic ...therapies. This study examined the characteristics at enrollment of patients with moderate to severe psoriasis who had insufficient responses to anti-tumor necrosis factor therapies (anti-TNFs).
Patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated an anti-TNF at enrollment were stratified on the basis of body surface area (BSA) improvement to <3% or a 75% improvement from enrollment to the 6-month follow-up visit (response versus insufficient response). Patient demographics and disease characteristics were described at enrollment, and changes in outcomes were assessed at 6-month follow-up for those who received anti-TNFs.
Of 180 anti-TNF initiators who had ≥1 follow-up visit, 50.6% were classified as responders. Logistic regression modeling showed that female sex was significantly associated with a decreased likelihood of achieving a response (OR = 0.534, 95% CI = 0.289-0.988, p = .046).
Despite the small sample size and short follow-up period, these findings may help dermatologists to identify patients with moderate to severe psoriasis who have unmet treatment needs.
Biologic therapies have revolutionized the management of moderate-to-severe psoriasis; however, there are a limited number of US real-world studies characterizing patients based on response to these ...treatments. This study examined characteristics at enrollment and change in outcomes of US patients with moderate-to-severe psoriasis who achieved insufficient responses with ustekinumab.
This study included patients enrolled in the Corrona Psoriasis Registry from April 2015 to June 2018 who initiated ustekinumab at enrollment and who were stratified based on achievement of psoriasis body surface area improving to <3% or by 75% from enrollment to the 6-month follow-up visit (response vs insufficient response). Patient demographics and disease characteristics were described at enrollment, and changes in outcomes were assessed at 6-month follow-up for ustekinumab responders and insufficient responders.
Of the 178 patients who initiated ustekinumab in the Corrona Psoriasis Registry and had ≥1 follow-up visit, 99 (55.6%) were classified as responders at the 6-month follow-up visit. Logistic regression modeling showed that increasing age was significantly associated with a decreased likelihood of achieving a response (OR, 0.981 95%CI, 0.962-0.999; p = .049).
These findings may help dermatologists characterize patients with moderate-to-severe psoriasis who have inadequate responses to biologic treatments.
The 52-week results from the CLEAR (NCT02074982) study showed high and superior efficacy of secukinumab versus ustekinumab in clearing skin and improving patient-reported outcomes, with comparable ...safety profile in subjects with moderate to severe psoriasis. Here, we analyzed the efficacy and safety of secukinumab in Asian subjects from the CLEAR study. In this double-blind, phase IIIb study, eligible subjects with moderate to severe plaque psoriasis were randomized (1:1) to receive s.c. injection of secukinumab 300 mg or ustekinumab as per label. Of 62 subjects included in Asian subanalyses, 23 were randomized to secukinumab and 39 to ustekinumab. A significantly higher proportion of subjects achieved 90% or more improvement in Psoriasis Area and Severity Index (PASI 90) with secukinumab versus ustekinumab at week 16 (78.3% vs 35.9%, P = 0.0010) and at week 52 (60.9% vs 33.3%, P = 0.0196). Similarly, a higher proportion of subjects achieved PASI 100 with secukinumab versus ustekinumab at week 16 (43.5% vs 10.3%, P = 0.0029) and at week 52 (30.4% vs 12.8%, P = 0.0704). The median time to achieve 50% improvement in baseline PASI was 2.8 weeks in the secukinumab group versus 6.3 weeks in the ustekinumab group. The safety profile of secukinumab was in line with the known profile and no deaths occurred. Overall, 95.7% and 84.6% of subjects remained on secukinumab and ustekinumab, respectively. Similar to the core study, secukinumab showed sustained and superior efficacy with faster response versus ustekinumab, and no new or unexpected safety concerns were identified, in Asian subjects with moderate to severe plaque psoriasis.
Background: Conventional measurements for assessing psoriasis treatment effects capture improvements at fixed, pre-specified timepoints, failing to account for cumulative clinical benefit over time.
...Objective: Explore the innovative concept of "cumulative clinical benefit" by examining the effect of secukinumab over 52 weeks in moderate-to-severe psoriasis patients.
Methods: Cumulative clinical benefit was determined as the area-under-the-curve of the percentage of responders over 52 weeks (AUC
0-52 wks
), using pooled data from two phase III trials for patients receiving secukinumab (300 or 150 mg) or etanercept.
Results: Normalized cumulative benefit with secukinumab 300 mg, secukinumab 150 mg, and etanercept was 74.2%, 63.2%, and 50.5%, respectively, for PASI 75; 58.0%, 42.5%, and 29.5%, respectively, for PASI 90; 32.3%, 18.8%, and 8.7%, respectively, for PASI 100; and 58.3%, 47.9%, and 38.3%, respectively, for DLQI 0/1. 52-week PASI 75 clinical benefit ratios for secukinumab 300 and 150 mg versus etanercept were 1.47 and 1.25, respectively; the ratio of the two secukinumab doses was 1.17, favoring 300 mg.
Limitations: Post hoc analysis.
Conclusion: Cumulative clinical benefit estimated by AUC
0-52 wks
is a novel measure for comparing psoriasis treatments. Secukinumab 300 mg provides greater cumulative clinical benefit than secukinumab 150 mg; both provide greater cumulative benefit than etanercept.
Auvi-Q is a novel epinephrine autoinjector (EAI) that provides audio and visual cues for patients at risk for life-threatening allergic reactions.
We tested the preference for Auvi-Q or EpiPen with ...regard to method of instruction, preference to carry, device size, and device shape.
This large, multicenter, simulated-use study evaluated whether adults (aged 18-65 years), caregivers (parents/guardians aged 18-65 years of children aged 5-17 years), and children (aged 11-17 years), with and without experience in using an EAI, had a preference for the current design of Auvi-Q or the current design of EpiPen. Participants were given a scenario that involved anaphylaxis and were instructed to simulate use of an EAI. They received and tested each device individually according to the randomization assignment. After testing both devices, they completed a survey to indicate their preference for Auvi-Q versus EpiPen.
Among all 693 participants combined, Auvi-Q was preferred over EpiPen on all study end points (P < .001). For experienced and inexperienced participants in all 3 groups (adults, caregivers, and children), Auvi-Q was preferred over EpiPen for method of instruction, preference to carry, and device size (all P < .001). The preference for Auvi-Q device shape was not significant among experienced children (P = .10); however, it was significant for inexperienced children (P = .04) and highly significant for experienced and inexperienced adults and caregivers (P < .001).
In this large multicenter, simulated-use study, Auvi-Q was preferred over EpiPen by experienced and inexperienced adults, caregivers, and children.
Atopic dermatitis (AD) is a chronic, inflammatory, intensely pruritic skin disorder associated with significant patient burden. Interleukin (IL)-13 is a cytokine that acts as a driver of immune ...dysregulation, skin-barrier dysfunction, and microbiome dysbiosis that characterizes AD, and is consistently overexpressed in AD skin. Tralokinumab is a fully human immunoglobulin (Ig) G4 monoclonal antibody that binds specifically to IL-13 with high affinity, thereby inhibiting subsequent downstream IL-13 signaling. Three pivotal phase 3 clinical trials demonstrated that tralokinumab 300 mg every other week, as monotherapy or in combination with topical corticosteroids as needed, provides significant improvements in signs and symptoms of moderate-to-severe AD, as measured by Investigator's Global Assessment 0/1 (clear/almost clear) and Eczema Area and Severity Index-75 at Week 16. Improvements were observed soon after tralokinumab initiation and were maintained over 52 weeks of therapy. Tralokinumab significantly improved patient-reported outcomes such as itch and sleep, and demonstrated a safety profile comparable with placebo; conjunctivitis during tralokinumab therapy was generally mild. Similar results were observed in a phase 3 adolescent trial. The role of IL-13 in the pathophysiology of AD justifies a targeted approach and a wealth of clinical data supports tralokinumab as a new therapeutic option for people with moderate-to-severe AD.
Background
Injectable poly‐L‐lactic acid (PLLA) is a synthetic polymer indicated for the correction of facial wrinkles and folds. Animal studies have shown that implantation of PLLA stimulates ...collagen synthesis; human studies have been limited.
Objective
To investigate human tissue response to injectable PLLA.
Methods and Materials
In this exploratory single‐arm, open‐label study, 14 healthy subjects were administered injectable PLLA; punch biopsies at 3, 6, and 12 months were analyzed for qualitative and quantitative changes from baseline in collagen types I and III and assessed for inflammatory responses.
Results
Quantitative and qualitative increases were observed for collagen types I and III at 3 and 6 months and were statistically significant for collagen type I at 3 and 6 months. Post hoc analyses at 12 months showed nominal collagen increases but were hindered by technical difficulties. The degree of inflammatory response was similar to baseline at 3, 6, and 12 months; all subjects were found to have no or mild inflammation after baseline. Adverse events were mild and among those reported previously.
Conclusion
Results of this study in humans found statistically significant stimulation of collagen type I with no or mild inflammatory response after administration of injectable PLLA.
Background: Real-world studies evaluating patients with challenging-to-treat localizations of psoriasis (scalp, nail, and palmoplantar) are limited. Objective: To characterize patients with versus ...without psoriasis in challenging-to-treat areas seen in routine US clinical practice. Methods: This retrospective observational study included all adult patients with psoriasis enrolled in the Corrona Psoriasis Registry between April 2015 and May 2018 who initiated a biologic therapy at registry enrollment. Patients were stratified by the presence of scalp, nail, or palmoplantar psoriasis (nonmutually exclusive groups). Patient demographics, clinical characteristics, disease activity, and patient-reported outcome measures (pain, fatigue, itch, EuroQol visual analog scale EQ VAS, Dermatology Life Quality Index DLQI, and Work Productivity and Activity Impairment questionnaire WPAI) were assessed at registry enrollment and compared between patients with versus without each challenging-to-treat area using nonparametric Kruskal-Wallis tests for continuous variables and χ 2 or Fisher exact tests for categorical variables. Generalized linear regression models were used to estimate differences in disease activity and patient-reported outcomes between patients with versus without each challenging-to-treat area. Results: Among 2,042 patients with psoriasis (mean age ±SD, 49.6 ± 14.7 years; 51.5% male), 38.4% had psoriatic arthritis (PsA), 38.1% had scalp psoriasis, 16.0% had nail psoriasis, 10.9% had palmoplantar psoriasis, and 26.2% had a combination of ≥2 challenging-to-treat areas and PsA; only 34.2% had body plaque psoriasis without PsA or challenging-to-treat areas. Patients in all challenging-to-treat groups reported higher (mean 95% CI) itch (scalp, 58.01 57.62–58.40 vs. 54.35 53.99–54.72; nail, 56.42 56.02–56.81 vs. 55.59 55.20–55.97; palmoplantar, 60.22 59.86–60.59 vs. 55.15 54.79–55.54) and lower EQ VAS (scalp, 68.12 67.78–68.48 vs. 69.46 69.12–69.81; nail, 66.21 65.89–66.55 vs. 69.48 69.14–69.83; palmoplantar, 66.21 66.07–66.75 vs. 69.29 68.94–69.94) scores than those without the respective challenging-to-treat localization. Patients with nail or palmoplantar psoriasis reported higher pain, fatigue, and DLQI scores than those without. Higher proportions of patients with scalp or palmoplantar psoriasis reported work impairment compared with those without. Conclusion: Two-thirds of patients with psoriasis who initiated biologic therapy had PsA and/or ≥1 challenging-to-treat area. Patients with challenging-to-treat areas had worse patient-reported outcome scores than those without, indicating a significant burden of challenging-to-treat areas on patients’ quality of life.
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