scholarly journals Efficacy of secukinumab and adalimumab in psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis: Results from the EXCEED, a randomised, double‐blind head‐to‐head monotherapy study

2021 ◽  
Author(s):  
A.B. Gottlieb ◽  
J.F. Merola ◽  
K. Reich ◽  
F. Behrens ◽  
P. Nash ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Plaque Psoriasis ◽  
Double Blind ◽  
Severe Plaque Psoriasis

scholarly journals Oral tofacitinib efficacy, safety and tolerability in Japanese patients with moderate to severe plaque psoriasis and psoriatic arthritis: A randomized, double‐blind, phase 3 study

2016 ◽  
Vol 43 (8) ◽  
pp. 869-880 ◽  
Author(s):  
Akihiko Asahina ◽  
Takafumi Etoh ◽  
Atsuyuki Igarashi ◽  
Shinichi Imafuku ◽  
Hidehisa Saeki ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Plaque Psoriasis ◽  
Japanese Patients ◽  
Phase 3 ◽  
Double Blind ◽  
Severe Plaque Psoriasis

scholarly journals Efficacy and Safety of HLX03, an Adalimumab Biosimilar, in Patients with Moderate-to-Severe Plaque Psoriasis: A Randomized, Double-Blind, Phase III Study

2021 ◽  
Author(s):  
Lin Cai ◽  
Linfeng Li ◽  
Hao Cheng ◽  
Yangfeng Ding ◽  
Zhenshu Biao ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Severe Plaque Psoriasis ◽  
Phase Iii Study

scholarly journals Efficacy and safety of netakimab, a novel anti-IL-17 monoclonal antibody, in patients with moderate to severe plaque psoriasis. Results of a 54-week randomized double-blind placebo-controlled PLANETA clinical trial

2021 ◽  
Vol 97 (4) ◽  
pp. 80-91
Author(s):  
Luis Puig ◽  
Andrey L. Bakulev ◽  
Muza M. Kokhan ◽  
Alexey V. Samtsov ◽  
Vladislav R. Khairutdinov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Monoclonal Antibody ◽  
Plaque Psoriasis ◽  
Safety Data ◽  
Interleukin 17 ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Severe Plaque Psoriasis ◽  
To Receive

Background. Netakimab (NTK), an original humanized anti-interleukin-17 monoclonal antibody, showed therapeutic efficacy in moderate to severe plaque psoriasis in a phase 2 clinical study. Herein we report the results of 54 weeks of a phase 3 trial. Aim. To evaluate the efficacy and safety of two NTK regimens vs. placebo in moderate to severe plaque psoriasis. Methods. PLANETA is the ongoing randomized double-blind placebo-controlled clinical trial. 213 patients with moderate to severe plaque psoriasis were randomly assigned to receive NTK 120 mg once every 2 weeks (NTK Q2W), NTK 120 mg once every 4 weeks (NTK Q4W) or placebo. During the first 3 weeks, patients received subcutaneous injections of NTK or placebo (according to the allocation) once a week. Patients in the NTK Q2W group then received NTK at weeks 4, 6, 8, and 10. Subjects in the NTK Q4W group received NTK at weeks 6 and 10 and placebo at weeks 4 and 8. Patients in the placebo group received placebo injections at weeks 4, 6, 8, and 10. Treatment was unblinded at week 12. During the open-label phase, patients in both NTK groups continued to receive NTK Q4W. The primary efficacy endpoint was the proportion of patients in each group who achieved a 75% or greater reduction from baseline in psoriasis area and severity index (PASI 75) at week 12. Results. A total of 77.7%, 83.3%, and 0% of patients had a PASI 75 response at week 12 in the NTK Q2W, NTK Q4W, and placebo groups, respectively (P 0.0001, Fishers exact test, ITT). The effect was maintained throughout the 1-year treatment. NTK showed a good safety profile and low immunogenicity. Conclusion. Treatment with NTK results in high rates of sustained clinical response in patients with moderate to severe plaque psoriasis. The study is ongoing; thus, long-term use efficacy and safety data are forthcoming.

Biologic Therapy Utilization in Patients With Moderate to Severe Psoriasis and Psoriatic Arthritis: An Observational Summary of Biologic Therapy Use in a Clinical Setting

2018 ◽  
Vol 22 (6) ◽  
pp. 567-576 ◽  
Author(s):  
Wayne P. Gulliver ◽  
Shane Randell ◽  
Susanne Gulliver ◽  
Valerie Gregory ◽  
Sean Nagle ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Clinical Research ◽  
Plaque Psoriasis ◽  
Biologic Therapy ◽  
Severe Psoriasis ◽  
Second Line ◽  
Biologic Therapies ◽  
Biologic Treatment ◽  
Treatment Pathways ◽  
Severe Plaque Psoriasis

Plaque psoriasis affects approximately 2% to 3% of the global population, with psoriatic arthritis observed in approximately 20% to 30% of these individuals. Upon advances in research pathophysiology and treatment over the past decade, biologic therapies have been used more to treat moderate to severe psoriasis. In Canada, reimbursement bodies have defined prior authorization criteria to determine patient eligibility for funding of biologic treatments in moderate to severe plaque psoriasis. Generally, patients will have been treated with conventional therapies such as topical steroids, phototherapy, or systemic treatments such as methotrexate and cyclosporine before starting a biologic therapy. In difficult cases or severe flares in otherwise controlled disease, practitioners may augment the regimen with one or more conventional treatments. The objective of this observational report was to identify treatment pathways for psoriasis and psoriatic arthritis patients in Canada by examining initial biologic treatment and subsequent treatment optimization patterns for informed reimbursement discussions and decisions. A retrospective chart review was conducted at Newlab Clinical Research using medical records of patients who received at least 1 of 4 biologic agents approved at that time of the survey in Canada for the treatment of plaque psoriasis (adalimumab, etanercept, infliximab, ustekinumab). The study population consisted of patients who had moderate to severe plaque psoriasis, diagnosed by a dermatologist, for at least 6 months before the study index date and who attended Newlab Clinical Research between 2008 and 2013. All current and previous agents prescribed for the treatment of psoriasis were captured. A total of 248 patients with psoriasis treated with biologics were identified, of whom 27 (10.9%) were also diagnosed with psoriatic arthritis. Prior to initiating treatment with a biologic, most patients (72.1%) were treated with (or contraindicated to) methotrexate/cyclosporine. Treatment was supplemented with topical agents (70.6%) and/or followed by a course of ultraviolet light phototherapy (51.6%). Only 2.4% of patients were treated with a biologic first. Of 248 patients treated with biologics, almost half (47.6%) needed add-on therapy, whereas 16.5% of patients had an increase in dose or dosing interval. Furthermore, 14.1% of patients added a topical agent, 10.5% a topical steroid, or 6.5% a course of phototherapy while continuing biologic therapies. Finally, 30.4% of patients switched to another biologic treatment. Adalimumab was the most common agent used as a second-line agent (37.2%), and patients who started on adalimumab mainly switched to ustekinumab as a second-line agent (73.9%). Infliximab was the agent least often used as second-line therapy.

scholarly journals Certolizumab pegol: new opportunities for treatment of moderate to severe plaque psoriasis

2019 ◽  
Vol 95 (5) ◽  
pp. 50-57
Author(s):  
A. A. Kubanov ◽  
A. L. Bakulev ◽  
M. I. Gluzmin ◽  
M. M. Kokhan ◽  
L. S. Kruglova ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Conflict Of Interest ◽  
Plaque Psoriasis ◽  
Randomized Clinical Trials ◽  
Placental Transfer ◽  
Certolizumab Pegol ◽  
Fab Fragment ◽  
Potential Conflict ◽  
Severe Plaque Psoriasis ◽  
Tnf Α

Tumor necrosis factor alpha (TNF-α) is one of the key inflammatory cytokines in the pathogenesis of psoriasis and psoriatic arthritis, and its inhibition with genetically engineered biological drugs ensures control of the main symptoms of these diseases. Certolizumab pegol is a PEGylated (linked to polyethylene glycol) Fab’ fragment of a monoclonal antibody that inhibits human TNF-α. It is approved for treatment of moderate to severe plaque psoriasis and psoriatic arthritis. This review summarizes the results of randomized clinical trials of efficacy and safety of certolizumab pegol in plaque psoriasis (CIMPASI 1, CIMPASI 2, and CIMPACT) and psoriatic arthritis (Rapid-PsA). The represented data demonstrate high efficacy of certolizumab pegol is bio-naïve patients and in patients previously exposed to other TNF inhibitors or IL17 inhibitors. The absence of the Fc-fragment in certolizumab pegol ensures minimal to no placental transfer of the drug and enables its usage during the entire pregnancy.Conflict of interest: the authors state that there is no potential conflict of interest requiring disclosure in this article.

scholarly journals Emerging treatment options for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis: evaluating bimekizumab and its therapeutic potential

2019 ◽  
Vol Volume 9 ◽  
pp. 29-35 ◽  
Author(s):  
Andrea Chiricozzi ◽  
Clara De Simone ◽  
Barbara Fossati ◽  
Ketty Peris
Keyword(s):  
Psoriatic Arthritis ◽  
Plaque Psoriasis ◽  
Therapeutic Potential ◽  
Treatment Options ◽  
Severe Plaque Psoriasis
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