Ixekizumab—An Effective and Safe Treatment for Moderate-to-Severe Plaque Psoriasis in Patients Previously Treated With Other IL-17 Inhibitors: Results From IXORA-P

2019 ◽  
Vol 4 (4) ◽  
pp. 180-185 ◽  
Author(s):  
Kim Papp ◽  
Andrew Blauvelt ◽  
John Sullivan ◽  
Yayoi Tada ◽  
Paula Polzer ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Therapeutic Option ◽  
Previous Treatment ◽  
Severity Index ◽  
Interleukin 17 ◽  
Severe Plaque Psoriasis ◽  
Previously Treated ◽  
Double Blinded ◽  
The Impact ◽  
Blinded Trial

Background: The impact of treatment with interleukin 17 (IL-17) inhibitors on the efficacy of subsequent IL-17 inhibitor therapy is unknown. Objective: To evaluate the impact of previous treatment with IL-17 inhibitors on the 52-week efficacy of ixekizumab in patients with moderate-to-severe psoriasis. Methods: In a phase 3, randomized, double-blinded trial (IXORA-P; NCT02513550), patients with moderate-to-severe plaque psoriasis were randomized (2:1:1) to ixekizumab 80 mg every 2 weeks (IXE Q2W, n = 611), every 4 weeks (IXE Q4W, n = 310), or IXE Q4W/IXE Q2W dose adjustment (per predefined criteria; n = 306). Psoriasis Area and Severity Index 75%, 90%, and 100% response rates (PASI 75, PASI 90, and PASI 100) were assessed. Results: Overall, 288 (23.5%) of 1227 patients were IL-17 inhibitor experienced (brodalumab, 22.6%; secukinumab, 1.1%). The PASI 75, 90, and 100 at week 52 were similar between IL-17 inhibitor-naive and IL-17 inhibitor-experienced patients. The PASI 75 at week 52 for IL-17 inhibitor-naive and -experienced patients was 85% and 89% (IXE Q2W), 79% and 81% (IXE Q4W), and 83% and 85% (IXE Q4W/IXE Q2W), respectively. The PASI 90 at week 52 for IL-17 inhibitor-naive and -experienced patients was 79% and 82% (IXE Q2W), 65% and 67% (IXE Q4W), and 73% and 75% (IXE Q4W/IXE Q2W), respectively. The PASI 100 at week 52 for IL-17 inhibitor-naive and -experienced patients was 60% and 59% (IXE Q2W), 44% and 42% (IXE Q4W), and 49% and 52% (IXE Q4W/IXE Q2W), respectively. Safety findings were generally similar between IL-17 inhibitor-naive and -experienced patients. Conclusion: Ixekizumab was demonstrated to be an effective and safe therapeutic option for patients previously treated with other IL-17 inhibitors.

Ixekizumab: A Review of Its Use for the Management of Moderate to Severe Plaque Psoriasis

2018 ◽  
Vol 53 (3) ◽  
pp. 276-284 ◽  
Author(s):  
Sydney K. Shelton ◽  
Sandra R. Bai ◽  
Joseph K. Jordan ◽  
Amy Heck Sheehan
Keyword(s):  
Plaque Psoriasis ◽  
Data Extraction ◽  
Severity Index ◽  
Biological Agents ◽  
Phase Iii ◽  
Interleukin 17 ◽  
Upper Respiratory Tract ◽  
Efficacy And Safety ◽  
Severe Plaque Psoriasis ◽  
Tract Infections

Objective: To review the efficacy, safety, and place in therapy of ixekizumab for the treatment of moderate to severe plaque psoriasis. Data Sources: PubMed (1966 to July 2018) and clinicaltrials.gov were searched using the terms ixekizumab, LY2439821, interleukin-17, and psoriasis. Study Selection and Data Extraction: Human studies published in peer-reviewed medical journals in English were used. Data Synthesis: The efficacy and safety of ixekizumab has been primarily reported by 4 phase III trials (UNCOVER-1, UNCOVER-2, UNCOVER-3, and UNCOVER-J) and multiple post hoc analyses. The average proportions of patients achieving a 75%, 90%, and 100% reduction in their Psoriasis Area and Severity Index (PASI) were 89%, 70%, and 38%, respectively, after 12 weeks of therapy. PASI75 was maintained for up to 3 years in 80.5% of participants. Ixekizumab was statistically significantly more effective than ustekinumab, with 76.5%, compared with 59%, of patients achieving PASI90 in 52 weeks. The most common adverse events include nasopharyngitis (14.1%), upper respiratory tract infections (7.9%), and injection-site reactions (6.8%), which are similar to that for other biological agents. The risk of inflammatory bowel disease may be increased with ixekizumab. Relevance to Patient Care and Clinical Practice: This review summarizes and evaluates clinical data regarding the efficacy and safety of ixekizumab and discusses relevant differences compared with other biological agents used for the management of chronic plaque psoriasis. Conclusions: Ixekizumab is a highly efficacious and well-tolerated treatment option for patients with moderate to severe plaque psoriasis.

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.

Efficacy of Brodalumab for Moderate to Severe Plaque Psoriasis: A Canadian Network Meta-Analysis

2020 ◽  
Vol 24 (6) ◽  
pp. 561-572
Author(s):  
Weiguang Xue ◽  
Paranjoy Saharia ◽  
Emma Gray ◽  
Shoghag Khoudigian-Sinani ◽  
Véronique Gaudet ◽  
...  
Keyword(s):  
Relative Risk ◽  
Plaque Psoriasis ◽  
Meta Analysis ◽  
Credible Interval ◽  
Severity Index ◽  
Biologic Agents ◽  
Sensitivity Analyses ◽  
Induction Phase ◽  
Significant Heterogeneity ◽  
Severe Plaque Psoriasis

Background Several treatments for plaque psoriasis are available, but it remains challenging for physicians to make informed treatment decisions due to a lack of head-to-head trials. Objectives This network meta-analysis (NMA) compares the efficacy of brodalumab to other biologic agents in Canada for moderate-to-severe plaque psoriasis. Methods A systematic literature review of randomized controlled trials (RCTs) published before October 2017 was conducted to populate the NMA. Comparators included etanercept, infliximab, adalimumab, ustekinumab, secukinumab, ixekizumab, guselkumab, and placebo. The primary outcome was the psoriasis area and severity index (PASI) response at the end of induction phase. A random effects Bayesian multinomial likelihood and probit link model analyzed PASI 75, 90, and 100 responses. Inconsistency and heterogeneity were assessed. Sensitivity analyses were conducted to explore potential effect modifiers like baseline PASI score, age, and weight. Results A total of 43 RCTs were included. Brodalumab 210 mg had significantly better PASI response than etanercept, ustekinumab, adalimumab, secukinumab, and guselkumab and comparable responses to infliximab and ixekizumab. Relative risk of PASI 90 response for brodalumab varied from 2.84 (95% credible interval [CrI]: 2.35-3.52, P < .05) to 0.99 (95% CrI: 0.88-1.11, ns) compared to etanercept and ixekizumab. This was similar across PASI 75 responses, but a larger relative risk between brodalumab and all comparators except ixekizumab was observed for PASI 100. No significant heterogeneity or inconsistencies were identified. The results were consistent across sensitivity analyses, indicating robustness of the results. Conclusion Brodalumab 210 mg has efficacy superior to most biologic agents for moderate-to-severe plaque psoriasis in Canada.

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis

2019 ◽  
Vol 54 (4) ◽  
pp. 380-387 ◽  
Author(s):  
Wendy Li ◽  
Rima Ghamrawi ◽  
Wasim Haidari ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trials ◽  
Phase Ii ◽  
Plaque Psoriasis ◽  
Data Extraction ◽  
Severity Index ◽  
Phase Iii ◽  
Cochrane Library ◽  
Severe Plaque Psoriasis ◽  
Phase Iii Clinical Trials ◽  
Interleukin 23

Objective: Risankizumab (Skyrizi), an interleukin-23 (IL-23) antagonist, was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in April 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this drug. Data Sources: A systematic literature review was performed using the terms “psoriasis AND risankizumab” in the OVID MEDLINE, PubMed, Cochrane Library, EMBASE, and Web of Science databases. ClinicalTrials.gov was searched to identify ongoing or nonpublished studies. Study Selection and Data Extraction: Articles written in English between January 2000 and October 2019 discussing phase II and phase III clinical trials were evaluated. Data Synthesis: By the primary end point at week 16 in phase III trials, more patients achieved Psoriasis Area and Severity Index 90 receiving 150 mg risankizumab (72%-75%) compared with placebo (2.0%-4.9%, P < 0.001), 45 or 90 mg ustekinumab (42.0%-48%, P < 0.0001), and 40 mg adalimumab (47%, P < 0.0001). More patients achieved a static Physician’s Global Assessment score of 0 or 1 receiving 150 mg risankizumab (84%-88%) compared with placebo (5.1%-7.8%, P < 0.001), 45 or 90 mg ustekinumab (62%-63%, P < 0.0001), and 40 mg adalimumab (60%, P < 0.0001). Risankizumab was well tolerated across all studies. Conclusion: Risankizumab is a newly FDA-approved IL-23 inhibitor that shows particular promise in the treatment of plaque psoriasis. Based on this review, it is an effective and safe addition to the armamentarium of biologics that are currently available.

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