Kim Papp

Kim Papp
Probity Medical Research Inc. · Research

MD, PhD

About

543
Publications
94,353
Reads
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34,647
Citations
Additional affiliations
January 2001 - December 2005
The University of Western Ontario
Position
  • Research Assistant
June 1993 - present
Probity Medical Research Inc.
Probity Medical Research Inc.
Position
  • President and Director of Research

Publications

Publications (543)
Article
Importance Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis. Objective To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis. Design, Setting, and Partic...
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Background Deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, inhibits cytokine signaling in psoriasis pathogenesis. Objective Demonstrate deucravacitinib superiority versus placebo and apremilast in moderate to severe plaque psoriasis on ≥75% reduction from baseline in Psoriasis Area and Severity Index (PASI 75) and static Ph...
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Introduction: The objective of this work was to assess the efficacy and safety of risankizumab in psoriatic arthritis (PsA) over 76 weeks. Methods: In this double-blind, dose-ranging phase 2 study, adults with active PsA were randomized 2:2:2:1:2 to risankizumab 150 mg at weeks 0, 4, 8, 12, and 16 (arm 1), 150 mg at weeks 0, 4, and 16 (arm 2), 1...
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Background and objectives: Once-daily, fixed-combination calcipotriol 50 μg/g (Cal) plus betamethasone dipropionate 0.5 mg/g (BD) is available in aerosol foam and cream formulations. As no head-to-head data are available, we use a matching-adjusted indirect comparison (MAIC) approach to compare Cal/BD foam and cream. Methods: Anchored and unanch...
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Background Effective, well-tolerated oral psoriasis treatments are needed. Objective To compare the efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor (TYK2), versus placebo and apremilast in adults with moderate to severe plaque psoriasis. Methods Participants were randomized 2:1:1 to deucravacitinib 6 mg QD (...
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Objectives Determine the impact of 24-week risankizumab (RZB) versus placebo (PBO) on patient-reported outcomes (PROs) in patients with psoriatic arthritis (PsA) and inadequate response to one or two biologics (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Methods Patients in the Phase 3 trial, KEEPsAK...
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Background: People living with human immunodeficiency virus (PLHIV) have a similar prevalence of psoriasis as the general population, though incidence and severity correlate with HIV viral load. Adequately treating HIV early renders the infection a chronic medical condition and allows PLHIV with a suppressed viral load (PLHIV-s) to live normal liv...
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Background Real-world knowledge of the burden of hidradenitis suppurativa (HS) on patients remains limited. Objectives To measure the impact of adalimumab on moderate-to-severe HS patients’ health-related quality of life (HRQoL) and work productivity. Methods In 23 Canadian centres, 138 adults with moderate-to-severe HS requiring a change in ongo...
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Importance: Primary results from the Measure Up 1 and Measure Up 2 studies demonstrated upadacitinib efficacy and safety through 16 weeks in patients with atopic dermatitis. Longer-term outcomes remain unknown. Objective: To evaluate long-term (52 weeks) efficacy and safety of upadacitinib treatment in patients with atopic dermatitis. Design, s...
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IntroductionDeucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship...
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IntroductionPsoriasis (Pso) is a common, immune-mediated, chronic-relapsing, inflammatory skin disease. While a great deal is known about Pso and its treatment, there remain several treatment scenarios unaddressed by clinical studies. To be effective, treatment for Pso must alter the activity of one or more immunological pathways important in the p...
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Background Tapinarof cream is a topical aryl hydrocarbon receptor–modulating agent under investigation for the treatment of psoriasis. Tapinarof modulates the expression of interleukin-17 and the skin-barrier proteins filaggrin and loricrin. Methods Download a PDF of the Research Summary. We conducted two identical phase 3 randomized trials of tap...
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Introduction Du fait de la nature chronique du psoriasis en plaques, il est important de maintenir l’efficacité du traitement dans le temps. Nous rapportons ici les résultats groupés de trois études de phase 3 concernant le maintien de la réponse sur 1 an chez des patients présentant un psoriasis en plaques modéré à sévère et qui ont obtenu un blan...
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Psoriasis (PsO) requires safe and effective long‐term management to reduce the risk of recurrence and decrease the frequency of relapse. Topical PsO therapies are a cornerstone in the management of PsO though safety concerns limit the chronic, continuous use of topical corticosteroids and/or vitamin D3 analogues. Evidence‐based guidelines on optima...
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Real‐world and long‐term data on biologic treatment changes – including switching, discontinuation, dose escalation, and interval change (both increasing and decreasing) – are required to understand treatment patterns for psoriasis (PsO) in Canada. The study objectives were to evaluate the time to first biologic treatment change and to document the...
Article
an inadequate response to biologics may reach 30% in psoriasis patients.1,2 In other inflammatory diseases, a positive effect of adding methotrexate (MTX) to adalimumab has been reported.3,4 In this real-world, Canadian multicenter, single-arm, phase IIIb, open-label study, sub-optimal responders who have been receiving adalimumab for ≥16 weeks, wh...
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Background Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials. Objectives We evaluated safety data from risankizumab psoriasis phase 1–3 clinical trials. Methods Short-term safety (through week 16) was analyzed using integrated data from five phase 2 and 3 clinical...
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Objective: Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain t...
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IntroductionDupilumab is approved to treat moderate-to-severe atopic dermatitis (AD) in several countries in patients as young as 6 years of age. Since its approval, practical issues related to the use of dupilumab for AD have arisen, with particular interest in transitioning from current therapies and managing medication overlap, considerations fo...
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IntroductionThe phase 3 PSO LONG study (NCT02899962) demonstrated superior efficacy of proactive (PM) versus reactive management (RM) using calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis. Here, we evaluated whether certain baseline parameters had an effect on time to first relapse (TTFR), number of rel...
Article
Background: Long-term efficacy, safety, and quality of life with ixekizumab (IXE) through 5 years in UNCOVER-1 and UNCOVER-2 patients with baseline scalp, nail, or palmoplantar psoriasis were assessed. Methods: Patients included in this intent-to-treat subanalysis had baseline involvement in at least one of the three anatomic areas (scalp, finge...
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The Psoriasis Area and Severity Index (PASI) is the most widely used clinical measure in clinical trials to assess disease severity of plaque psoriasis. However, the PASI is not a precise measure of severity with less precision when the regional area of involvement is < 10% of the BSA of a specific anatomical region. Degradation of precision result...
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Background Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess durability of their efficacy and safety profile over time. Objectives To evaluate long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis. Methods LIMMitless is an ongo...
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IntroductionPsoriasis Longitudinal Assessment and Registry (PSOLAR) was designed in 2007 as the first disease-based registry for patients with psoriasis.Objective The aim of this study was to discuss methodological limitations and post hoc analyses in long-term safety registries using learnings from analyses of a potential safety risk for major adv...
Article
Background Upadacitinib (UPA) is an oral Janus kinase inhibitor currently under evaluation for the treatment of psoriatic arthritis (PsA). Previous 24-week results from the SELECT-PsA 2 study in patients with PsA and prior inadequate response to ≥1 biologic disease-modifying antirheumatic drug (bDMARD) demonstrated UPA efficacy with a safety profil...
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Background Risankizumab (RZB) is a humanized immunoglobin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding its p19 subunit. RZB is being investigated as a treatment for adults with psoriatic arthritis (PsA). Objectives To compare the efficacy and safety of RZB vs placebo (PBO) for the treatment of active PsA in patients...
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Introduction: Risankizumab has demonstrated efficacy in treating moderate-to-severe psoriasis. The phase-3 IMMhance trial (NCT02672852) examined the effect of continuing versus withdrawing from risankizumab treatment on psoriasis severity, including the Psoriasis Area and Severity Index (PASI) and static Physician Global Assessment (sPGA). However...
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Background: Upadacitinib is an oral Janus kinase (JAK) inhibitor with greater inhibitory potency for JAK1 than JAK2, JAK3, and tyrosine kinase 2. We aimed to assess the efficacy and safety of upadacitinib compared with placebo for the treatment of moderate-to-severe atopic dermatitis. Methods: Measure Up 1 and Measure Up 2 were replicate multice...
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Objectives To analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseas...
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IntroductionUpadacitinib is a Janus kinase inhibitor under investigation in patients with psoriatic arthritis (PsA). This study assessed the 56-week efficacy and safety of upadacitinib in patients with PsA and an inadequate response or intolerance to biologic therapy.Methods In the phase 3 SELECT-PsA 2 study, patients were randomized to 56 weeks of...
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Background/Aims Upadacitinib (UPA) is a selective JAK inhibitor licensed for moderate-severe rheumatoid arthritis (RA), under evaluation for treating psoriatic arthritis (PsA). We aim to assess the efficacy and safety of UPA versus placebo (PBO) in PsA patients with prior inadequate response or intolerance to ≥ 1 biologic disease-modifying anti-rh...
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Background: Sonelokimab (also known as M1095) is a novel trivalent nanobody comprised of monovalent camelid-derived (ie, from the Camelidae family of mammals, such as camels, llamas, and alpacas) nanobodies specific to human interleukin (IL)-17A, IL-17F, and human serum albumin. Nanobodies are a novel class of proprietary therapeutic proteins base...
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Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin-17A and interleukin-17F. The efficacy and safety of bimekizumab as compared with the tumor necrosis factor inhibitor adalimumab in patients with moderate-to-severe plaque psoriasis have not been extensively examined. Methods: We randomly assigned patients...
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Introduction: An estimated 2-4% of Western populations are thought to have psoriasis, with a regional incidence ranging from 0.09% to 11.43%. Variance in estimates is a result of differences in study populations, methodology, regional differences, and definitions of disease. Reliable prevalence estimates of plaque psoriasis are challenging to esta...
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Coronavirus disease 2019 (COVID-19) is caused by SARS-CoV-2, a novel RNA virus that was declared a global pandemic on 11 March 2020. The efficiency of infection with SARS-CoV-2 is reflected by its rapid global spread. The SARS-CoV-2 pandemic has implications for patients with inflammatory skin diseases on systemic immunotherapy who may be at increa...
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Background There is an unmet need for a treatment for psoriasis that results in complete skin clearance with a reliably quick response. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. We aimed to compare the efficacy and safety of bimekizumab with placebo and ustekinumab in patients wi...
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IntroductionAlthough many biologic therapies are effective for clearing skin of patients with psoriasis, some lose effectiveness over time. This phase 2 open-label extension (OLE) trial was designed to investigate the long-term safety and efficacy of risankizumab.Methods In the phase 2, double-blind, active comparator, predecessor trial (NCT0205448...
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Background Upadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis (PsA). We evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD). Methods In this 24-week randomised, placebo-controlled, double-blind,...
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Introduction Le psoriasis est l’exemple parfait d’une maladie occasionnée par les Th17 ; des éléments toujours plus nombreux suggèrent que l’IL-17A au même titre que l’IL-17F influencent son immunopathogénie. Le bimékizumab se lie sélectivement à l’IL-17A et l’IL-17F et les neutralise. Matériel et méthodes Dans BE VIVID (NCT03370133), une étude pi...
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Background: Topical psoriasis treatment relies on a reactive, rather than long-term proactive, approach to disease relapse. Objective: Assess long-term efficacy and safety of proactive psoriasis management with twice-weekly calcipotriene 0.005%/betamethasone dipropionate 0.064% (Cal/BD) foam. Methods: Phase III trial (NCT02899962) included a 4...
Article
Background: Roflumilast cream (ARQ-151) is a highly potent, selective phosphodiesterase-4 inhibitor in development for once-daily topical treatment of chronic plaque psoriasis. Objectives: To assess the safety and efficacy of once-daily roflumilast cream 0.5% and 0.15% in patients with chronic plaque psoriasis. Methods: This phase 1/2a study enroll...
Article
Background Systemic oral phosphodiesterase type 4 (PDE-4) inhibitors have been effective in the treatment of psoriasis. Roflumilast cream contains a PDE-4 inhibitor that is being investigated for the topical treatment of psoriasis. Methods In this phase 2b, double-blind trial, we randomly assigned adults with plaque psoriasis in a 1:1:1 ratio to u...
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Objectives To evaluate the efficacy of guselkumab through four years of continuous treatment for psoriasis. Methods In the phase 3 VOYAGE 1 trial, 837 patients with moderate-to-severe psoriasis were randomized to receive guselkumab 100 mg every-8-weeks, placebo, or adalimumab 40 mg every-2-weeks. Patients in the placebo and adalimumab groups cross...
Article
Background Plaque psoriasis (PsO) is a chronic inflammatory disease that often presents at peak reproductive age in women of child-bearing potential (WOCBP). With the emergence of biologic therapies to treat PsO, guidance on disease management in WOCBP is needed to inform treatment decisions before, during, and after pregnancy. Objectives To devel...
Article
Tildrakizumab is a fairly new type of medicine called a biologic, used for the treatment of moderate‐to‐severe psoriasis. The drug prevents the action of a specific molecule in the body involved in inflammation, known as cytokine interleukin (IL)‐23p19. Previous studies have shown it to be superior to a placebo (an inactive substance, like a “sugar...
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Tildrakizumab 是一种相当新型的药物,称为生物制剂,用于治疗中度至重度牛皮癣。这种药物可以防止体内一种与炎症有关的特定分子的活动,这种分子被称为细胞因子白细胞介素 (IL)‐23p19。 先前的研究表明,它优于安慰剂(一种非活性物质,像“糖丸”一样)和一种旧的生物制剂,即 TNF 抑制剂 Etanercept。然而,试验很少反映出现实世界的经历,患者可能会从一种药物换到另一种药物,改变药物剂量或中断治疗,例如因为感染而这样做。 作者(位于美国、加拿大和德国)回顾了两项研究的结果,一项是将两种不同剂量的 Tildrakizumab(每天 100 mg 或 200 mg)与安慰剂进行比较,另一项是将其与 Etanercept 进行比较,其中纳入总共 1862 名患有中度到重度斑块型银...
Article
Background Upadacitinib (UPA) is an oral, reversible, JAK inhibitor approved for treatment of moderate to severe rheumatoid arthritis (RA) and currently under evaluation for treatment of psoriatic arthritis (PsA). Objectives To assess the efficacy and safety of UPA versus placebo (PBO) in patients (pts) with PsA and prior inadequate response or in...
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Objectives: The aim of this integrated analysis is to evaluate the long-term safety and tolerability of ixekizumab in adults with psoriasis, PsA and axial SpA. Methods: Integrated safety data from 21 clinical trials are presented by indication in patients who received at least one dose of ixekizumab. Adverse events (AEs) and treatment-emergent a...
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Background Dual neutralization of both interleukin-17A and interleukin-17F with the monoclonal antibody bimekizumab may have greater efficacy in psoriasis than neutralization of interleukin-17A alone. Objective To provide longer-term efficacy and safety data for bimekizumab from a phase 2b extension study in patients with moderate-to-severe psoria...
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Background: Psoriatic arthritis (PsA) is a chronic, systemic immune-mediated inflammatory musculoskeletal disease. The onset of dermatologic symptoms often precedes rheumatic manifestations. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA that has been shown to improve dermatologic symptoms in patients with PsA. Objectives:...
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Importance Risankizumab selectively inhibits interleukin 23, a cytokine that contributes to psoriatic inflammation. Objective To evaluate the efficacy and safety of risankizumab vs placebo and continuous treatment vs withdrawal in adults with moderate to severe plaque psoriasis. Design, Setting, and Participants Multinational, phase 3, randomized...
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Full-text available
Palmoplantar psoriasis is a chronic (long term) and difficult‐to‐treat form of psoriasis that affects the palms of the hands and the soles of the feet. The disease causes reddish, scaly plaques on the palms and/or soles with or without the presence of such scales elsewhere on the body. Since palms and soles are affected, the patient can have seriou...
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掌跖银屑病是一种慢性(长期)、难以治疗的银屑病,累及手掌和足底。该病引起手掌和/或足底淡红色、鳞屑性斑块,伴或不伴身体其他部位的此类鳞屑。由于手掌和脚掌受累,患者在执行日常生活任务如行走、洗澡和进食时可能会出现严重问题。这会导致其生活质量严重紊乱,这类患者可能会社交退缩或患有抑郁症和信心不足。 一种名为苏金单抗的药物已被证明在治疗斑块状银屑病(背部、躯干、手部和腿部有鳞屑的银屑病)患者方面具有快速和持久的有效性;然而,尚未专门研究其对掌跖银屑病的作用。 随机对照试验是将患者随机分配到治疗组的一类临床试验,也有不接受任何研究中治疗的对照组。GESTURE 是规模最大、持续时间最长的随机对照研究,旨在评估苏金单抗在掌跖银屑病患者中的疗效和安全性。对即刻(16 周)和长期(2·5 年)结果进行了评...
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IntroductionAtopic dermatitis (AD) is an incurable, inflammatory skin disease characterized by skin barrier disruption and immune dysregulation. Although AD is considered a childhood disease, adult onset is possible, presenting with daily sleep disturbance and functional impairment associated with itch, neuropsychiatric issues (anxiety and depressi...
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Biologics are powerful drugs used to treat a range of diseases including psoriasis. They can be very effective; however, the body's immune system, which normally fights off infection, can produce ‘anti‐drug antibodies’ (or ADAs) that see biologics as harmful ‘invaders’ and try to deactivate them. These antibodies may result in serious side effects...
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生物制剂是用于治疗包括银屑病在内的一系列疾病的强大药物。它们可以非常有效;但身体的免疫系统通常会阻抗感染,可产生“抗药抗体”(ADAS), 这些抗体将“生物制剂”当作有害的“侵入者”, 并试图阻止它们。这些抗体可能会导致严重的副作用, 和/或可能降低药物的有效性。 在美国、加拿大和德国进行的这项研究的作者在参加三项 tildrakizumab 生物制剂临床试验的患者中评估了抗药抗体。 在这三项试验中, 患者服用 100 mg 或 200 mg tildrakizumab。1400 例患者从研究的第 12 周至第 16 周接受研究,780 例在第 52‐64 周接受研究。 100 mg 剂量组患者中有 3% 出现了抗药抗体。这导致第 52 周平均临床应答降低(意味着药物疗效不佳)。但存在抗体与...