Manmath Patekar
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View article: Long‐Term Efficacy and Safety of Ligelizumab as Re‐Treatment in Patients With Chronic Spontaneous Urticaria
Long‐Term Efficacy and Safety of Ligelizumab as Re‐Treatment in Patients With Chronic Spontaneous Urticaria Open
Background Chronic spontaneous urticaria (CSU) is a debilitating skin condition affecting approximately 1% of the global population, characterized by recurrent wheals, angioedema, or both for over 6 weeks without identifiable external trig…
View article: Model‐Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria
Model‐Informed Drug Development for Ligelizumab in Patients With Chronic Spontaneous Urticaria Open
Model‐informed drug development (MIDD) has been increasingly applied to guide decision‐making, ameliorate efficiency, and enhance the likelihood of successful trials. The development of ligelizumab, a humanized anti‐IgE monoclonal antibody…
View article: Ligelizumab use for chronic spontaneous urticaria – Authors' reply
Ligelizumab use for chronic spontaneous urticaria – Authors' reply Open
View article: Comprehensive Assessment of Pharmacokinetics, Pharmacodynamics, and Tolerability of Ligelizumab in Healthy Volunteers and Patients with Chronic Spontaneous Urticaria to Optimize Its Subcutaneous Delivery System
Comprehensive Assessment of Pharmacokinetics, Pharmacodynamics, and Tolerability of Ligelizumab in Healthy Volunteers and Patients with Chronic Spontaneous Urticaria to Optimize Its Subcutaneous Delivery System Open
Ligelizumab is a highly potent, humanized IgG1, anti-IgE monoclonal antibody. To explore its optimal subcutaneous delivery, the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of ligelizumab from two Phase 1 studies in healt…
View article: Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials
Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials Open
View article: Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria: Results from the Phase-3 Pivotal Trials
Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria: Results from the Phase-3 Pivotal Trials Open
View article: Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study
Efficacy of Secukinumab Across Subgroups and Overall Safety in Pediatric Patients with Moderate to Severe Plaque Psoriasis: Week 52 Results from a Phase III Randomized Study Open
ClinicalTrials.gov: NCT03668613.
View article: Efficacy and safety of secukinumab over 52 weeks in Chinese psoriasis patients with concomitant psoriatic arthritis
Efficacy and safety of secukinumab over 52 weeks in Chinese psoriasis patients with concomitant psoriatic arthritis Open
Psoriasis is a chronic, systemic inflammatory disease characterized by demarcated, scaly, erythematous skin plaques. Psoriatic arthritis (PsA) is the most common comorbidity, with roughly 25% to 30% of psoriasis patients developing PsA dur…
View article: Secukinumab demonstrates efficacy, safety and tolerability upon administration by 2 mL autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial
Secukinumab demonstrates efficacy, safety and tolerability upon administration by 2 mL autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial Open
Secukinumab demonstrates efficacy, safety and tolerability upon administration by 2 mL autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial
View article: Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study
Efficacy, tolerability, patient usability, and satisfaction with a 2 mL pre-filled syringe containing secukinumab 300 mg in patients with moderate to severe plaque psoriasis: results from the phase 3 randomized, double-blind, placebo-controlled ALLURE study Open
Evidence shows good tolerability in patients for subcutaneous injection volumes up to 3 mL. We investigated efficacy, pharmacokinetics, and tolerability of secukinumab 300 mg/2 mL pre-filled syringe (PFS) in patients with moderate to sever…
View article: Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52‐week results from a Phase 3 double‐blind randomized, controlled trial
Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52‐week results from a Phase 3 double‐blind randomized, controlled trial Open
Background Secukinumab has demonstrated sustained long‐term efficacy with a favourable safety profile in various psoriatic disease manifestations in adults. Objectives Here, the efficacy and safety of two secukinumab dosing regimens [low d…
View article: Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis Open
Background: Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, w…
View article: Association of Secukinumab Treatment With Tuberculosis Reactivation in Patients With Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis
Association of Secukinumab Treatment With Tuberculosis Reactivation in Patients With Psoriasis, Psoriatic Arthritis, or Ankylosing Spondylitis Open
This study found that LTBI reported as an AE after secukinumab treatment was uncommon and appeared to support the use of secukinumab in chronic systemic inflammatory conditions.
View article: Perspective of Maternal Deaths: A Retrospective Autopsy Study
Perspective of Maternal Deaths: A Retrospective Autopsy Study Open
Reducing maternal mortality has been a constant struggle globally. The major causes of maternal mortality remain to be ante and post-partum haemorrhage, anaemia, obstructed labour, hypertensive disorders and post-partum infections, liver d…
View article: Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52‐week results from a double‐blind phase 3b trial (CLARITY)
Secukinumab maintains superiority over ustekinumab in clearing skin and improving quality of life in patients with moderate to severe plaque psoriasis: 52‐week results from a double‐blind phase 3b trial (CLARITY) Open
Background Secukinumab demonstrated superior efficacy over ustekinumab in the treatment of moderate to severe plaque psoriasis over 16 weeks in the CLARITY study and over 52 weeks in the CLEAR study. Objective To compare the efficacy and s…
View article: Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients
Comparison of pharmacokinetics, safety and tolerability of secukinumab administered subcutaneously using different delivery systems in healthy volunteers and in psoriasis patients Open
Aims The aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of secukinumab with different devices for subcutaneous (s.c.) administration of 2 mL. Methods A phase 1 study in healthy subjects with 6 devices to…
View article: Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results)
Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results) Open
View article: Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate‐to‐severe psoriasis through 5 years of treatment (<scp>SCULPTURE</scp> Extension Study)
Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate‐to‐severe psoriasis through 5 years of treatment (<span>SCULPTURE</span> Extension Study) Open
Background Secukinumab, a fully human monoclonal antibody that selectively neutralizes IL ‐17A, has been shown to have significant efficacy and a favourable safety profile in the treatment of moderate‐to‐severe psoriasis and psoriatic arth…