Daphne Chan
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View article: SPECTREM phase IIIb clinical trial results through week 16: guselkumab efficacy and safety for the treatment of low body surface area, moderate psoriasis with high-impact site involvement
SPECTREM phase IIIb clinical trial results through week 16: guselkumab efficacy and safety for the treatment of low body surface area, moderate psoriasis with high-impact site involvement Open
Background Patients with psoriasis affecting a low percentage of their body surface area (BSA) are under-represented in clinical studies and may face substantial disease burden if high-impact sites are affected. Objectives To evaluate in a…
View article: Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones
Guselkumab for Moderate to Severe Scalp Psoriasis Across All Skin Tones Open
Importance Varying hair textures and hair care practices contribute to nuances in clinical presentation and management of scalp psoriasis across diverse patient populations. Cohort B of the VISIBLE trial enrolled participants with moderate…
View article: Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones
Guselkumab for Moderate to Severe Psoriasis Across All Skin Tones Open
Importance Data and educational gaps in populations with skin of color contribute to racial and ethnic disparities in psoriasis treatment. Cohort A of the VISIBLE study includes participants with psoriasis who self-identify as belonging to…
View article: Long-Term Effectiveness of Guselkumab vs. Other Biologic Therapies Among Plaque Psoriasis Patients in the CorEvitas Psoriasis Registry
Long-Term Effectiveness of Guselkumab vs. Other Biologic Therapies Among Plaque Psoriasis Patients in the CorEvitas Psoriasis Registry Open
Introduction: The efficacy and real-world treatment persistence of guselkumab (GUS) has been shown to be superior to other advanced treatment options [1,2] for psoriasis (PsO); however, long-term real-world effectiveness vs. other biologic…
View article: Improving Diversity in a Novel Psoriasis Study
Improving Diversity in a Novel Psoriasis Study Open
Importance Diverse racial and ethnic representation in clinical trials has been limited, not representative of the US population, and the subject of pending US Food and Drug Administration guidance. Psoriasis presentation and disease burde…
View article: Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study
Efficacy and safety of guselkumab in patients with active psoriatic arthritis who had inadequate efficacy and/or intolerance to one prior tumor necrosis factor inhibitor: study protocol for SOLSTICE, a phase 3B, multicenter, randomized, double-blind, placebo-controlled study Open
View article: Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis Open
Clinicaltrials.gov identifiers: NCT01483599, NCT02207231, NCT02207244, NCT02203032, NCT02905331, NCT03090100, NCT02325219, NCT02319759, NCT03162796, NCT03158285, and NCT03796858.
View article: A clinical review of structural damage in psoriatic arthritis for dermatologists: From pathogenesis to ongoing controversies
A clinical review of structural damage in psoriatic arthritis for dermatologists: From pathogenesis to ongoing controversies Open
Psoriatic arthritis (PsA) is a chronic inflammatory disease that often goes unrecognized in patients with psoriasis. As a result, patients may develop significant structural damage before diagnosis and initiation of adequate treatment. Der…
View article: POS1538 SAFETY OF GUSELKUMAB ACROSS DIVERSE PATIENT SUBGROUPS WITH PSORIATIC DISEASE: AN INTEGRATED ANALYSIS OF 11 PHASE 2/3 CLINICAL STUDIES IN PSORIASIS AND PSORIATIC ARTHRITIS
POS1538 SAFETY OF GUSELKUMAB ACROSS DIVERSE PATIENT SUBGROUPS WITH PSORIATIC DISEASE: AN INTEGRATED ANALYSIS OF 11 PHASE 2/3 CLINICAL STUDIES IN PSORIASIS AND PSORIATIC ARTHRITIS Open
Background A higher prevalence of comorbidities, such as obesity, prior treatments, and certain demographics (e.g., age and sex) in patients (pts) with psoriatic disease (PsD) may lead to an increased risk of adverse events (AEs), sometime…
View article: Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses across seven clinical trials with more than 8600 patient-years of exposure
Safety of guselkumab treatment for up to 5 years in patients with moderate-to-severe psoriasis: pooled analyses across seven clinical trials with more than 8600 patient-years of exposure Open
Background Guselkumab has demonstrated favourable safety and efficacy across individual clinical studies in adults with moderate-to-severe plaque psoriasis. Objectives To evaluate the safety of guselkumab in patients with psoriasis using p…
View article: Malignancy rates through 5 years of follow-up in patients with moderate-to-severe psoriasis treated with guselkumab: Pooled results from the VOYAGE 1 and VOYAGE 2 trials
Malignancy rates through 5 years of follow-up in patients with moderate-to-severe psoriasis treated with guselkumab: Pooled results from the VOYAGE 1 and VOYAGE 2 trials Open
In patients treated with guselkumab for up to 5 years, malignancy rates were low and generally consistent with rates in general and psoriasis patient populations.
View article: E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis
E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis Open
Background/Aims Guselkumab is a monoclonal antibody approved to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA). In this analysis, safety data from 11 Phase 2/3 studies of guselkumab were pooled to evaluate g…
View article: Safety of guselkumab in patients with psoriasis with a history of malignancy: 5-year results from the VOYAGE 1 and VOYAGE 2 trials
Safety of guselkumab in patients with psoriasis with a history of malignancy: 5-year results from the VOYAGE 1 and VOYAGE 2 trials Open
The VOYAGE 1 and 2 studies of guselkumab in moderate-to-severe psoriasis are among the first studies of biologics to include patients with a history of malignancy. In these studies, 18 guselkumab-treated patients had a history of malignanc…
View article: 120 Safety of Guselkumab in Patients With Moderate to Severe Psoriasis: Pooled Analyses Across Clinical Studies
120 Safety of Guselkumab in Patients With Moderate to Severe Psoriasis: Pooled Analyses Across Clinical Studies Open
View article: Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study
Guselkumab for the Treatment of Crohn’s Disease: Induction Results From the Phase 2 GALAXI-1 Study Open
gov, Number: NCT03466411.
View article: Merits of a harmonised system to classify drug-related problems in Singapore
Merits of a harmonised system to classify drug-related problems in Singapore Open
View article: Maintenance Golimumab Treatment in Pediatric UC Patients With Moderately to Severely Active UC: PURSUIT PEDS PK Long-Term Study Results
Maintenance Golimumab Treatment in Pediatric UC Patients With Moderately to Severely Active UC: PURSUIT PEDS PK Long-Term Study Results Open
Background Long-term safety, pharmacokinetics, and efficacy of open-label golimumab therapy in children with moderate–severe ulcerative colitis were evaluated. Methods Week-6 golimumab responders (Mayo score decrease of ≥30% and ≥3 points …
View article: Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn’s Disease
Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn’s Disease Open
In an analysis of data from participants in phase 3 induction and maintenance trials, we found histologic improvement in a greater proportion of patients given ustekinumab vs placebo. The largest improvements occurred in patients who recei…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: A80 ENDOSCOPIC HEALING WITH USTEKINUMAB IN CROHN’S DISEASE: THE UNITI ENDOSCOPY SUB-STUDY
A80 ENDOSCOPIC HEALING WITH USTEKINUMAB IN CROHN’S DISEASE: THE UNITI ENDOSCOPY SUB-STUDY Open
AIMS: To evaluate endoscopic healing in the ustekinumab (UST) induction (UNITI-1&2) & maintenance (IM-UNITI) phase 3 studies. METHODS: Substudy patients (pts) had colonoscopies at baseline (UNITI Wk0), then 8 & 52 weeks later (IM-UNITI Wk4…
View article: P396 Pharmacokinetics, immunogenicity and clinical outcomes of golimumab from the PURSUIT PEDS ulcerative colitis study long-term (through week 126) extension
P396 Pharmacokinetics, immunogenicity and clinical outcomes of golimumab from the PURSUIT PEDS ulcerative colitis study long-term (through week 126) extension Open
To evaluate the pharmacokinetics (PK) and immunogenicity of the anti-TNF golimumab (GLM) in children with ulcerative colitis (UC) from the PURSUIT PEDS PK study long-term extension (LTE). A multicentre open-label study was performed to ass…
View article: Su1923 Pharmacokinetics and Exposure-Response Relationships of Golimumab in Pediatric Patients With Moderate to Severe Ulcerative Colitis: Results From a Multicenter Open Label Study
Su1923 Pharmacokinetics and Exposure-Response Relationships of Golimumab in Pediatric Patients With Moderate to Severe Ulcerative Colitis: Results From a Multicenter Open Label Study Open
View article: P-180 Gene Expression Profiling Indicates Similar Molecular Pathways Are Active in Adult and Pediatric Ulcerative Colitis
P-180 Gene Expression Profiling Indicates Similar Molecular Pathways Are Active in Adult and Pediatric Ulcerative Colitis Open
Patients with pediatric onset UC manifest more extensive disease at presentation than do adults; however, large genome wide association studies failed to reliably identify pathways that distinguish these 2 populations. It remains unclear w…