Publications by authors named "Menter A"

Background: Psoriasis is an inflammatory skin disease that impacts a heterogeneous group of patients and can have multiple clinical manifestations. Risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis.

Objectives: To evaluate the long-term efficacy of risankizumab according to baseline patient characteristics, and for the treatment of high-impact disease manifestations (nail, scalp and palmoplantar psoriasis), through 256 weeks of continuous treatment in the phase 3 LIMMitless study.

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Article Synopsis
  • The VOLTAIRE-X study analyzed the effects of continuous use of adalimumab (Humira) vs. switching between adalimumab and its biosimilar, adalimumab-adbm (Cyltezo), in patients with plaque psoriasis.
  • Results indicated similar pharmacokinetics, effectiveness, and side effects between the two groups, suggesting that switching treatments did not negatively impact patients.
  • The findings led to the FDA approving adalimumab-adbm as interchangeable with adalimumab RP, allowing pharmacists to substitute one for the other without needing prescriber approval.
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Background: Anti-PD-1 and PD-L1 (collectively PD-[L]1) therapies are approved for many advanced solid tumors. Biomarkers beyond PD-L1 immunohistochemistry, microsatellite instability, and tumor mutation burden (TMB) may improve benefit prediction.

Methods: Using treatment data and genomic and transcriptomic tumor tissue profiling from an observational trial (NCT03061305), we developed Immunotherapy Response Score (IRS), a pan-tumor predictive model of PD-(L)1 benefit.

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Importance: Other than single-center case studies, little is known about generalized pustular psoriasis (GPP) flares.

Objective: To assess GPP flares and their treatment, as well as differences between patients with and patients without flares documented in US electronic health records (EHRs).

Design, Setting, And Participants: This retrospective cohort study included adult patients with GPP (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code L40.

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  • BI 695501 is a biosimilar approved by the FDA and was tested in the VOLTAIRE-X clinical trial to determine its interchangeability with the adalimumab reference product (RP).
  • The study aimed to evaluate if switching between adalimumab RP and BI 695501 affects patients' drug absorption and safety in a similar way compared to continuous use of adalimumab RP.
  • Results showed comparable pharmacokinetics between the switching group and the continuous group, with only slight differences in peak drug levels and overall exposure, suggesting that swapping the two treatments did not significantly alter their effectiveness.
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Psoriatic involvement in areas of the body such as nails, palms and soles (palmoplantar), and scalp is associated with dramatically negative effects on quality of life relative to involvement elsewhere in the body. Although numerous evidence-based studies demonstrate the efficacy of biologics for overall skin clearance in moderate-to-severe plaque psoriasis (including tumor necrosis factor α [TNFα] inhibitors and interleukin [IL]-17A, IL-12/IL-23, IL-23, IL-17F, and IL-17A/F inhibitors), large, randomized, placebo-controlled clinical studies of psoriasis with nail, palmoplantar, and scalp involvement are needed to better inform decision-making in clinical practice. Moreover, biologic failure caused by drug ineffectiveness is a common occurrence in patients who do not respond, lose response, or are intolerant to treatment.

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Invasive fungal infection is a rare but serious potential consequence of biologic therapy. Herein, we report a case of cryptococcal meningitis in an otherwise immunocompetent patient receiving ixekizumab for the treatment of severe plaque psoriasis. We also discuss the relevant immunologic role of interleukin-17, the potential for synergistic effects when transitioning biologic therapies, and clinical considerations when treating patients with such medications.

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Introduction: We sought to understand key symptoms of generalized pustular psoriasis (GPP) and to confirm the relevance to patients and content validity of the Psoriasis Symptom Scale (PSS) in GPP.

Methods: A targeted literature review and clinical expert interviews were conducted as background research. Patients were interviewed individually (involving concept elicitation and cognitive interviews), and a separate patient workshop was conducted to determine disease-specific symptoms of importance.

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Despite the emergence of multiple biologic drug options for psoriasis, unmet treatment needs remain. Biologic therapies can vary in their effectiveness and adverse events, and many patients experience a loss of treatment effect over time. After lack of response, treatment may be switched to a biologic with a different mechanism of action.

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Article Synopsis
  • * Diagnosis can be difficult due to its rarity and the lack of established, evidence-based treatments, often leading to management strategies borrowing from standard plaque psoriasis therapies.
  • * Recent advances in understanding its causes have opened the door for new treatment options, particularly biologic therapies, with promising results from targeted therapies like spesolimab that inhibit the IL-36 pathway.
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Purpose: Tissue-based comprehensive genomic profiling (CGP) is increasingly used for treatment selection in patients with advanced cancer; however, tissue availability may limit widespread implementation. Here, we established real-world CGP tissue availability and assessed CGP performance on consecutively received samples.

Materials And Methods: We conducted a post hoc, nonprespecified analysis of 32,048 consecutive tumor tissue samples received for StrataNGS, a multiplex polymerase chain reaction (PCR)-based comprehensive genomic profiling (PCR-CGP) test, as part of an ongoing observational trial (NCT03061305).

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Introduction: In the USA, psoriasis affects approximately 3% of the population and costs more than $110 billion annually. The development of targeted biologics has revolutionized psoriasis management, but at an increasing cost. According to Joint AAD/NPF guidelines, an important need exists to identify biomarkers that can predict the appropriate biologic agent for patients.

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Background: Treating to absolute treatment targets rather than relative measures such as Psoriasis Area and Severity Index (PASI)-75 is emerging as an important clinical concept included in psoriasis guidelines and clinical practice. Achieving treatment targets is associated with achievement of long-term outcomes.

Objective: To evaluate the relationship between psoriasis severity, disease characteristics and achievement of PASI ≤2 with apremilast in a pooled analysis of the phase 3 ESTEEM 1 and 2 (NCT01194219 and NCT01232283), phase 3b LIBERATE (NCT01690299) and phase 4 UNVEIL (NCT02425826) clinical trials.

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Penile calciphylaxis is a rare cause of penile gangrene and is typically associated with multiple comorbidities, most commonly diabetes mellitus and hyperparathyroidism. It demonstrates a high mortality rate of 64% and is seen almost exclusively in patients with end-stage renal disease on hemodialysis. Underreporting of this disease likely occurs, contributing to a paucity of data and lack of formal therapeutic guidelines and approved treatments.

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Psoriasis is an immune-mediated inflammatory skin disease associated with numerous inflammatory comorbidities, including increased cardiovascular risk. The interleukin (IL)-23/IL-17 axis plays a central role in the immunopathogenesis of psoriasis and related comorbidities by acting to stimulate keratinocyte hyperproliferation and feed-forwarding circuits of perpetual T cell-mediated inflammation. IL-17 plays an important role in the downstream portion of the psoriatic inflammatory cascade.

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Article Synopsis
  • BI 695501 is a biosimilar to Humira® and was tested in a Phase III trial (VOLTAIRE-PSO) for patients with moderate-to-severe chronic plaque psoriasis.
  • The trial measured effectiveness based on the number of patients achieving at least a 75% reduction in psoriasis severity (PASI 75) after 16 and 24 weeks of treatment, finding similar response rates between BI 695501 and adalimumab.
  • Safety results showed that both treatments had comparable rates of treatment-emergent adverse events and similar rates of anti-drug antibody positivity, indicating that BI 695501 is as safe and effective as the adalimumab reference product.
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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.

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Background: Bortezomib, lenalidomide, and dexamethasone (VRd) is a standard therapy for newly diagnosed multiple myeloma. Carfilzomib, a next-generation proteasome inhibitor, in combination with lenalidomide and dexamethasone (KRd), has shown promising efficacy in phase 2 trials and might improve outcomes compared with VRd. We aimed to assess whether the KRd regimen is superior to the VRd regimen in the treatment of newly diagnosed multiple myeloma in patients who were not being considered for immediate autologous stem-cell transplantation (ASCT).

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Introduction: Psoriasis is a chronic immune-mediated inflammatory skin disease that occurs in 2.5-3.5% of the general population.

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