Safety Of Brodalumab In Patients Research Articles

Effectiveness of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis Located in Difficult-to-Treat Areas.

Recent knowledge of psoriasis pathogenesis has led to the development of selective drugs. Among these, brodalumab is a monoclonal antibody targeting the interleukin (IL)-17A receptor approved for the treatment of moderate-to-severe plaque psoriasis. Biologics may be considered in patients with milder diseases in case of active psoriatic arthritis, severe impact on patient's quality of life, and involvement of sensitive and difficult-to-treat areas. These skin locations commonly require systemic drugs. Recently, psoriasis severity monitoring has also changed. Indeed, the clinical evaluation by means of specific efficacy scores was combined with serological evaluation by means of the assay of specific inflammatory biomarkers. An observational study enrolled patients affected by moderate-to-severe plaque psoriasis involving difficult-to-treat areas, undergoing treatment with brodalumab to evaluate the effectiveness and safety of brodalumab in patients with psoriasis affecting difficult-to-treat areas (scalp and palmoplantar regions). Secondary outcomes were the assessment of the development of serum markers of inflammation during the treatment period as well as the evaluation of the dermoscopic features of the affected sites to quantify disease activity and response to treatment. Twenty-five patients were included in the study. A statistically significant reduction from baseline in PASI, PSSI, ppPASI and DLQI values as early as week 24 was observed, with further improvement up to week 52. Plasma levels of MMP-3, VEGF-A, and hs-PCR decreased during treatment from week 0 to week 52. Our real-life experience suggests brodalumab as a valuable option for the management of psoriasis located in difficult-to-treat areas. Moreover, our study highlights that the use of brodalumab reduces the plasmatic levels of inflammatory biomarkers (MMP-3, VEGF-A and hs-PCR), showing how the drug modulates the skin inflammatory response by reducing systemic inflammation.

German S3-Guideline on the treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - Part 2: Treatment monitoring and specific clinical or comorbid situations.

German S3-Guideline on the treatment of Psoriasis vulgaris, adapted from EuroGuiDerm - Part 2: Treatment monitoring and specific clinical or comorbid situations.

15908 Long-term efficacy and safety of brodalumab in patients with or without metabolic syndrome

Background: We assessed the long-term efficacy and safety of brodalumab, a fully human anti–interleukin-17 receptor A monoclonal antibody, in patients with moderate to severe plaque psoriasis, stratified by baseline metabolic syndrome (MetSyn) status.

16525 Long-term efficacy and safety in clinical trials of brodalumab by prior response to adalimumab

Background: We assessed the long-term efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis stratified by prior adalimumab response status at baseline.

Brodalumab for the treatment of moderate-to-severe plaque-type psoriasis: a real-life, retrospective 24-week experience.

Brodalumab was efficacious and safe in moderate-to-severe plaque-type psoriasis in the AMAGINE trials; published reports under real-life conditions are limited. To evaluate the effectiveness and safety of brodalumab in patients with moderate-to-severe plaque-type psoriasis in a real-world setting. This observational, retrospective study enrolled adult patients (≥18years) with moderate-to-severe plaque-type psoriasis who underwent 24weeks of treatment with brodalumab at 17 Italian dermatological centres. Baseline data included demographics, comorbidities, age of onset and duration of psoriasis and previous treatments. Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), static PGA of Genitalia, Dermatology Life Quality Index and patient satisfaction were assessed at weeks 0, 4, 12 and 24; adverse events were recorded. Seventy-eight patients (mean age 47.9years, 71.8% male, average disease duration 16.8years) were enrolled. A rapid and significant reduction in mean PASI score was observed after 4weeks of treatment, decreasing further at weeks 12 and 24 (all P<0.0001 vs. baseline). A higher number of cardiometabolic comorbidities and previous therapies were negatively associated with the achievement of PASI 90 at all assessments. Brodalumab was effective in bio-experienced patients, including those who had failed on anti-interleukin (IL)-17 therapies. Quality of life and patient satisfaction increased significantly during treatment (P<0.0001 and P<0.01 vs. baseline, respectively). Treatment was interrupted in 9 (11.5%) patients due to adverse events (n=4), lack of efficacy (n=3), lost to follow-up (n=1) and surgical procedure (n=1). Brodalumab is effective and safe in the treatment of moderate-to-severe psoriasis in a real-world setting, including in patients with failure to anti-IL17 therapies.

Brodalumab to the Rescue: Efficacy and Safety of Brodalumab in Patients with Psoriasis and Prior Exposure or Inadequate Response to Biologics.

While biologic therapies for psoriasis are effective for many patients, some patients may lose response, have inadequate control of disease, or develop intolerance to certain biologic agents. It may therefore be beneficial for patients whose psoriasis fails to respond to one biologic to switch to a different biologic therapy, in particular one with a different mechanism of action. However, it remains unclear how prior biologic exposure or lack of response affects the efficacy and safety of subsequent biologics in patients with moderate-to-severe psoriasis. Brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, has previously been shown to be efficacious in treating moderate-to-severe psoriasis in three large phase 3 trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3). In this review, we summarize the efficacy and safety of brodalumab in patients with moderate-to-severe psoriasis and a history of biologic exposure. Further, we describe improvements in skin clearance and quality of life measures as well as safety in patients who had inadequate response to ustekinumab and who were rescued with brodalumab therapy. Lastly, we discuss improvements in skin clearance following rescue with brodalumab in patients whose disease failed to respond to secukinumab and ixekizumab. The findings of our review suggest that brodalumab is a safe and efficacious treatment regardless of past biologic use or lack of response to prior biologic therapy.

Long-term Efficacy and Safety of Brodalumab in Patients With or Without History of Psoriatic Arthritis: Analysis of Two Phase 3 Psoriasis Studies

Abstract not available.

Long-term Efficacy and Safety of Brodalumab in Patients With Psoriasis Disease Duration &lt;10 and ≥10 Years: Analysis of Two Phase 3 Studies

Abstract not available.

Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator–controlled phase 3 AMAGINE-2 trial

Randomizedcontrolled trials have shown the efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis. To evaluate the efficacy and safety of brodalumab through 120weeks of treatment in the AMAGINE-2 trial. Patients received ustekinumab through week 52 followed by brodalumab 210mg every 2weeks, continuous brodalumab 210mg every 2weeks, or any dose of brodalumab. Efficacy data were reported through 120weeks by using observed data, last observation carried forward, and nonresponder imputation analyses. Of patients who received brodalumab 210mg every 2weeks, 84.4%, 75.6%, and 61.1% achieved 75%, 90%, and 100% improvement from baseline in Psoriasis Area and Severity Index at 120weeks (observed data analysis), respectively. Patients who received brodalumab 210mg every 2weeks after receiving ustekinumab through 52weeks achieved a similar skin clearance response as patients who received continuous brodalumab 210mg every 2weeks. Safety through 120weeks was comparable to that of the blinded study periods. A large number of discontinuations toward the end of the study (31% in the final 6months) were due to early termination and led to differences between observed data and nonresponder imputation results. Brodalumab is well tolerated and showed robust efficacy for more than 2years.

Efficacy and safety of brodalumab in patients with inadequate response to ustekinumab: Analysis of two phase 3 psoriasis studies

Efficacy and safety of brodalumab in patients with inadequate response to ustekinumab: Analysis of two phase 3 psoriasis studies

Efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis: Results of AMAGINE-1, a phase 3, randomized, double-blind, placebo-controlled study through week 12

Efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis: Results of AMAGINE-1, a phase 3, randomized, double-blind, placebo-controlled study through week 12