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.

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.

scholarly journals Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data

2020 ◽  
Author(s):  
Chak Sing Lau ◽  
Yi-Hsing Chen ◽  
Keith Lim ◽  
Marc de Longueville ◽  
Catherine Arendt ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Viral Hepatitis ◽  
Central Europe ◽  
Real World ◽  
Certolizumab Pegol ◽  
Safety Data ◽  
Asia Pacific ◽  
Hbv Reactivation ◽  
Post Marketing

Abstract Introduction/objectives To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). Method CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. Results Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). Conclusions CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. Key Points:• TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions.• With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence.• Safety profile of biologics in real-world settings complements controlled studies.• TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.

scholarly journals Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients

Dermatology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Katharina A. Drerup ◽  
Claudia Seemann ◽  
Sascha Gerdes ◽  
Ulrich Mrowietz
Keyword(s):  
Cohort Study ◽  
Real World ◽  
Plaque Psoriasis ◽  
Prospective Cohort ◽  
Registry Data ◽  
Comparable Efficacy ◽  
Routine Practice ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Severe Plaque Psoriasis

<b><i>Background:</i></b> After registration of drugs, evidence about efficacy and safety is solely based on data of phase 2/3 clinical trial programs. A major drawback is the selection of patients following inclusion/exclusion criteria. There is a considerable time and knowledge gap between study and registry data that evaluate real-world evidence (RWE). To close this gap, prospective cohort data are helpful. <b><i>Objectives:</i></b> Soon after tildrakizumab, an interleukin 23p19-inhibitor, was registered for moderate-to-severe plaque psoriasis, a prospective single-center cohort study was established to evaluate efficacy and safety of tildrakizumab in daily practice. <b><i>Methods:</i></b> Following approval of tildrakizumab, patients with moderate-to-severe plaque psoriasis eligible for systemic treatment were included into the Kiel Tildra Cohort (KTC) and followed using routine assessments of efficacy, psoriasis area and severity index (PASI), body surface area (BSA), dermatology life quality index (DLQI), itch (visual analog scale), and safety. Data of the KTC were compared to the respective phase 3 clinical trials. <b><i>Results:</i></b> The KTC included 150 patients differing substantially from those in the trial program. There was a high rate of previous systemic (87.3%) and biologic (31.8%) therapy and of comorbidity in the KTC as compared to the phase 3 studies. Due to the best practice approach, baseline PASI was lower in the KTC, but DLQI was similar in both groups. At the time of this analysis, 126 patients completed week 28, 92 patients week 52, and 58 patients week 76, respectively. There was a constant improvement in PASI, BSA, DLQI, and itch from baseline until week 76. There was no clinically meaningful laboratory abnormality. <b><i>Conclusions:</i></b> Patients treated in routine practice with tildrakizumab differed substantially from the phase 3 studies. Despite systemic pre-treatment and increased comorbidity, tildrakizumab showed comparable efficacy and safety in the KTC. Prospective cohort studies are a suitable tool to generate RWE before registry data become available.

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.

Ixekizumab (Interleukin 17A Antagonist): 12-week Efficacy and Safety Outcomes in Real-world Clinical Practice

2018 ◽  
Vol 23 (2) ◽  
pp. 174-177 ◽  
Author(s):  
Jorge R. Georgakopoulos ◽  
Michelle Phung ◽  
Arvin Ighani ◽  
Jensen Yeung
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Plaque Psoriasis ◽  
Current Knowledge ◽  
Therapeutic Option ◽  
Injection Site Reaction ◽  
Retrospective Chart Review ◽  
Phase Iii ◽  
Physician Global Assessment ◽  
Efficacy And Safety

Background: Current knowledge of the efficacy and safety of ixekizumab is limited to data from phase III randomized controlled trials (RCTs). A gap exists in our understanding of treatment outcomes of this newly available biologic in real-world clinical practice. Objective: This study explores the efficacy and safety of ixekizumab in non-RCT patients to compare real-world outcomes to those reported in RCTs. Methods: We conducted a multicentre, retrospective chart review of patients treated with ixekizumab therapy for moderate-to-severe plaque psoriasis. Efficacy (Psoriasis Area and Severity Index score of 75 or Physician Global Assessment of 0 or 1) and safety (reported adverse events [AEs]) were assessed following a 12-week treatment period. Results: Of the 60 patients included, 45 (75.0%) achieved efficacious outcomes after 12 weeks of ixekizumab treatment. Twenty-two (36.7%) patients experienced one or more AEs, of whom only 3 (5.0%) withdrew from treatment as a result. Common AEs included injection site reaction/erythema/pain (13.3%) and dermatitis (5.0%). Conclusion: Ixekizumab has shown to be a safe and effective therapeutic option for plaque psoriasis in real-world practice. It does not appear that patients experience more AEs in real-world clinics than those in clinical trials.

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