Efalizumab for the Treatment of Moderate to Severe Plaque Psoriasis

2005 ◽  
Vol 39 (9) ◽  
pp. 1476-1482 ◽  
Author(s):  
Joseph K Jordan
Keyword(s):  
Clinical Trials ◽  
T Cell Activation ◽  
Plaque Psoriasis ◽  
Systemic Therapy ◽  
Cell Activation ◽  
Data Extraction ◽  
Efficacy And Safety ◽  
Severe Plaque Psoriasis ◽  
Medline Search ◽  
Prior Systemic Therapy

OBJECTIVE: To review the pharmacology, efficacy, and safety of efalizumab for the treatment of moderate to severe plaque psoriasis. DATA SOURCES: A MEDLINE search (1966–May 2005%) using the key words hu1124, anti-CD11a, efalizumab, Raptiva, Xanelim, and psoriasis was conducted. References of identified articles were reviewed for additional citations. STUDY SELECTION AND DATA EXTRACTION: Clinical trials evaluating the pharmacology, efficacy, and safety of efalizumab for treatment of moderate to severe plaque psoriasis in adults were included in our review. DATA SYNTHESIS: Efalizumab's ability to inhibit the binding of CD11a, a subunit of leukocyte function–associated antigen type 1, to intracellular adhesion molecule 1 results in decreased T-cell activation and migration, 2 key steps in the immunopathogenesis of psoriasis. Results of clinical trials have demonstrated that efalizumab administered subcutaneously is a safe and effective treatment for moderate to severe plaque psoriasis. Efalizumab was well tolerated in trials, with the majority of adverse events arising with the first dose and decreasing with subsequent doses. The high cost of this agent and lack of head-to-head trials with other drugs will likely restrict its use to patients who have failed prior systemic therapy or phototherapy. CONCLUSIONS: Efalizumab is a safe and effective therapy for treatment of moderate to severe plaque psoriasis in patients who have failed prior systemic therapy or phototherapy.

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.

Efficacy and Safety of Apremilast Monotherapy for Moderate to Severe Psoriasis: Retrospective Study

2018 ◽  
Vol 22 (3) ◽  
pp. 290-296 ◽  
Author(s):  
Arvin Ighani ◽  
Jorge R. Georgakopoulos ◽  
Linda L. Zhou ◽  
Scott Walsh ◽  
Neil Shear ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Real World ◽  
Plaque Psoriasis ◽  
Safety Data ◽  
Retrospective Chart Review ◽  
Oral Drug ◽  
Efficacy And Safety ◽  
Full Spectrum ◽  
Severe Plaque Psoriasis

Background: Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. Objective: Assess the efficacy and safety of apremilast monotherapy in real-world practice. Methods: A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a ≥75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting ≥1 AE at 16 weeks. Results: Thirty-four patients were included. Efficacy: 19 patients (55.9%) achieved PASI-75 or PGA 0/1. Safety: 23 patients (67.6%) experienced ≥1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). Conclusion: Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study.

Fingolimod: A Novel Immunosuppressant for Multiple Sclerosis

2007 ◽  
Vol 41 (10) ◽  
pp. 1660-1668 ◽  
Author(s):  
Brandon A Brown ◽  
Pranish P Kantesaria ◽  
Lisa M McDevitt
Keyword(s):  
Multiple Sclerosis ◽  
Renal Transplantation ◽  
T Cell Activation ◽  
English Language ◽  
Cell Activation ◽  
Therapeutic Option ◽  
Data Extraction ◽  
Medline Search ◽  
Language Studies ◽  
Study Results

Objective: To review the pharmacology, pharmacokinetics, efficacy, and safety of fingolimod, a novel immune modulator. Data Sources: Information was obtained through a MEDLINE search (1966–February 2007) and from published abstracts. Search terms included fingolimod, FTY720, FTY-720, and sphlngosine-1-phosphate receptor agonist. Study Selection and Data Extraction: All English-language studies and abstracts pertaining to fingolimod were considered for inclusion. Preference was given to human data. Data Synthesis: Fingolimod Is the first in a new class of immune modulators known as the sphingosine-1-phosphate receptor agonists. It is administered orally once dairy and causes a dose-related reduction in the number ot circulating lymphocytes by preventing their egress from secondary lymph organs, but it does not alter T-cell activation or proliferation. Bradycardia and lymphopenia are the most common adverse effects. Clinical trials have evaluated the efficacy of fingolimod in renal transplantation and multiple sclerosis (MS). Further research for renal transplantation will not take place, but Phase 3 studies in MS are underway, as Phase 2 study results are favorable. Conclusions: Due to its distinct mechanism of action and its oral administration, fingolimod may be a useful therapeutic option for patients with relapsing forms of MS. More data are needed to assess the safety and clinical utility of fingolimod.

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.

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