CMET-37. SAFETY AND EFFICACY OF INTRAVENTRICULAR BIOLOGIC AGENTS AS PART OF A MULTI-AGENT INTRAVENTRICULAR TREATMENT REGIMEN FOR PATIENTS WITH NEOPLASTIC MENINGITIS

Biologic therapies have revolutionized the treatment of moderate-to-severe psoriasis, and several biologic agents are currently available to patients. However, the high cost associated with these drugs contributes to the underutilization of biologics and the resultant undertreatment of disease. In recent years, biosimilars have been developed for several of the commonly used biologic agents, with reported similar efficacy and safety profiles to the original agents. They are also somewhat less costly than the original biologic agents that they are similar to. Despite this, many dermatologists are still skeptical of biosimilars for a variety of reasons. It is important for dermatologists to familiarize themselves with the emerging safety and efficacy data for the biosimilar agents, so as to provide patients with safe, efficacious, and potentially affordable treatment options as biosimilars become available over the next several years. In this article, we set out to review available data regarding biosimilar medications in the treatment of psoriasis. A literature review was performed utilizing the PubMed database. The results of these studies indicate that biosimilars have a high degree of similarity regarding safety and efficacy when compared to their originator biologics for the treatment of psoriasis.

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CMET-02. ESTABLISHING THE SAFETY AND EFFICACY OF A NEW MULTI-AGENT INTRATHECAL TREATMENT PROTOCOL FOR PATIENTS WITH NEOPLASTIC MENINGITIS

Neuro-Oncology ◽

10.1093/neuonc/noz175.203 ◽

2019 ◽

Vol 21 (Supplement_6) ◽

pp. vi51-vi51

Author(s):

Samer Zammar ◽

Richard Eby ◽

Brad Zacharia ◽

Roy Strowd ◽

Stuart Grossman ◽

...

Keyword(s):

Median Survival ◽

Single Agent ◽

Treatment Protocol ◽

Outcome Data ◽

Neoplastic Meningitis ◽

Biological Agents ◽

Intrathecal Treatment ◽

Intraventricular Chemotherapy ◽

Multi Agent ◽

Agent Treatment

Abstract BACKGROUND The prognosis for neoplastic meningitis (NM) remains dismal and single-agent (rather than multi-agent) chemotherapy remains the standard of care. Objective: To analyze survival of patients with NM receiving multi-agent vs. single-agent intrathecal chemotherapy and evaluate the safety of antitumor intrathecal biological agents. METHODS We compared a standardized multi-agent intrathecal treatment cohort to the corresponding patient level data acquired from 6 of the 7 randomized controlled trials (RCTs) conducted in patients with NM, all of which used single-agent intraventricular therapies. The toxicity of intrathecal biological agents was studied by analyzing the outcome data form patients with NM treated with at least 1 intrathecal biological drug. RESULTS 283 patients receiving multi-agent therapy were compared to 290 patients from the RCTs. Patients and tumor characteristics did not differ between groups. All patients from the multi-agent patient group were included in an intent-to-treat model. For all solid tumors, median survival (multi-agent vs. single-agent treatment) was 211 vs. 97 days, hazard ratio (HR) 3.39, p< 0.001. For lymphoma, survival was 304 vs. 81 days, HR 2.10, p< 0.001. Stratified by tumor histology, median survival for breast cancer NM was 315 days [95% CI 248–449], for lung cancer 193 days [127- 200]; for melanoma 307 days [65–1492], and for primary brain tumors 253 days [187- 348]. No additional toxicity was seen in the multi-agent compared to the single-agent treatment groups. In 110 patients, grade III toxicity occurred in 5.3%, 3.1%, 0% and 0% of patients receiving rituximab, trastuzumab, panitumumab, and alpha interferon. No difference in survival was seen when comparing patients with and without treatment related toxicity in any histological groups. CONCLUSION Multi-agent intraventricular chemotherapy was associated with dramatically increased survival in patients with solid tumor and lymphomatous NM. Incorporating biologic agents as part of a multi-agent intrathecal treatment regimen is very safe.

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P14.07 Multi-agent vs. single-agent intra-ventricular chemotherapy for patients with neoplastic meningitis: evidence supporting a new paradigm

Neuro-Oncology ◽

10.1093/neuonc/nox036.394 ◽

2017 ◽

Vol 19 (suppl_3) ◽

pp. iii103-iii103

Author(s):

R. Eby ◽

B. Zacharia ◽

L. Cream ◽

D. Black ◽

D. Aregawi ◽

...

Keyword(s):

Single Agent ◽

Neoplastic Meningitis ◽

New Paradigm ◽

Multi Agent

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Dosing of Rviii-Singlechain Based on Clinical Bleeding Phenotypes Results in Low Bleeding Rates and Low Consumption in Patients Treated with Prophylaxis Two or Three Times Weekly

Blood ◽

10.1182/blood.v128.22.4969.4969 ◽

2016 ◽

Vol 128 (22) ◽

pp. 4969-4969

Author(s):

Katie St Ledger ◽

Nicole Blackman ◽

Alex Veldman ◽

Ingrid Pabinger

Keyword(s):

Treatment Regimen ◽

Study Design ◽

Extension Study ◽

Final Dose ◽

Spontaneous Bleeding ◽

Bleeding Rate ◽

Safety And Efficacy ◽

Prophylaxis Therapy ◽

Assignment Analysis ◽

Low Consumption

Abstract Introduction: Safety and efficacy of rVIII-SingleChain (AFSTYLA) was investigated in two pivotal and one extension study, comprising the Affinity program. The study design and instructions provided to the investigators allowed the physician to freely choose the dose assignment and regimen, based on the FVIII treatment regimen used prior to enrollment, and the subject's clinical bleeding phenotype. Adjustments of dose and schedule were allowed at any time during the study. Methods: This analysis investigates initial and final dose assignment and the corresponding total and spontaneous bleeding rates in subjects in the adult and adolescent study assigned to prophylaxis two or three times weekly (>80% of the subjects on prophylaxis therapy) in dosing brackets of 20 to <30 IU/kg, 30 to <40 IU/kg and 40 to ≤50 IU/kg. Results: In the final dose assignment, 43 subjects were assigned a dose of 20 to <30 IU/kg, 62 subjects were assigned a dose of 30 to <40 IU/kg, and 38 subjects were assigned a dose of 40 to ≤50 IU/kg. No differences were observed in the analysis by dose brackets in the adult and adolescent (12-65) population (complete or stratified by age); neither in the initial nor the final dose assignment analysis. The median annualized bleeding rate for the dosing brackets of 20 to <30 IU/kg, 30 to <40 IU/kg and 40 to ≤50 IU/kg was 1.93, 1.05 and 2.21, respectively. The median annualized spontaneous bleeding rate was 0, 0 and 0.50, respectively (final dose assignment). Conclusions: This data shows that dosing of rVIII-SingleChain based on clinical bleeding phenotypes results in low bleeding rates and low consumption in patients treated with prophylaxis two or three times weekly, with more than 70% of subjects being maintained at doses of <40 IU/kg. Disclosures St Ledger: CSL Behring: Employment. Blackman:CSL Behring: Employment. Veldman:CSL Behring: Employment. Pabinger:CSL Behring: Consultancy.

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Safety and Efficacy of Intravitreal Bevacizumab Followed by Pegaptanib Maintenance as a Treatment Regimen for Age-Related Macular Degeneration

Ophthalmic Surgery Lasers and Imaging ◽

10.3928/15428877-20061101-01 ◽

2006 ◽

Vol 37 (6) ◽

pp. 446-454 ◽

Cited By ~ 26

Author(s):

Mark S. Hughes ◽

Delia N. Sang

Keyword(s):

Macular Degeneration ◽

Treatment Regimen ◽

Intravitreal Bevacizumab ◽

Age Related Macular Degeneration ◽

Safety And Efficacy ◽

Age Related

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An open label study evaluating the safety and efficacy of a 16 week treatment regimen of alefacept in adults with moderate to severe atopic dermatitis

Journal of the American Academy of Dermatology ◽

10.1016/j.jaad.2006.10.821 ◽

2007 ◽

Vol 56 (2) ◽

pp. AB179

Keyword(s):

Atopic Dermatitis ◽

Treatment Regimen ◽

Severe Atopic Dermatitis ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Safety And Efficacy

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Biologic Treatment in Elderly Patients With Psoriasis: A Systematic Review

Journal of Cutaneous Medicine and Surgery ◽

10.1177/1203475419897578 ◽

2020 ◽

Vol 24 (2) ◽

pp. 174-186 ◽

Cited By ~ 4

Author(s):

Vijay Kumari Sandhu ◽

Arvin Ighani ◽

Patrick Fleming ◽

Charles W. Lynde

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Elderly Patients ◽

The Elderly ◽

Biologic Agents ◽

Cochrane Library ◽

Comorbid Conditions ◽

Biologic Treatment ◽

Similar Frequency ◽

Safety And Efficacy

With our aging population, an increasing number of psoriasis patients are classified as elderly. However, psoriasis treatment in older adults can be challenging, given an increased number of comorbid conditions and immunosenescence. Biologic agents present a solution to this treatment dilemma because of their high efficacy and favorable tolerability. The objective of this systematic review was to summarize the findings of clinical trial and real-world studies exploring the safety and efficacy of biologic agents in elderly patients with moderate-to-severe psoriasis. We searched MEDLINE, Embase, the Cochrane Library, and clinical trial databases. Studies analyzing biologics for psoriasis were included if elderly patients were the main population of interest or were a separate subgroup in their analysis. Eighteen articles met inclusion criteria after screening. Across all biologic classes, efficacy for biologics between nonelderly adult patient and elderly patients was similar. Adverse events (AEs) and infections occured at a similar frequency between both groups. However, serious AEs were more common in the elderly. The available literature on the safety and efficacy of biologic agents in elderly patients supports the use of these agents in this population. However, serious AEs and discontinuation due to AEs were more common in older patients. As elderly patients have a higher burden of comorbid conditions and an increased baseline vulnerability for AE, physicians should continue to be prudent in screening before initiating biologics and monitor patients more closely as AEs tend to be more severe.

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