scholarly journals Therapy with Biologic Agents After Diagnosis of Solid Malignancies: Results from the Corrona Registry

2019 ◽  
Vol 46 (11) ◽  
pp. 1438-1444 ◽  
Author(s):  
Dimitrios A. Pappas ◽  
Sabrina Rebello ◽  
Mei Liu ◽  
Jennifer Schenfeld ◽  
YouFu Li ◽  
...  
Keyword(s):  
Cancer Diagnosis ◽  
Real World ◽  
Biologic Therapy ◽  
Tumor Necrosis Factor Inhibitor ◽  
Biologic Agents ◽  
Biologic Treatment ◽  
Solid Malignancy ◽  
Kaplan Meier ◽  
Factor Inhibitor ◽  
Previously Treated

Objective.Guidelines suggest that rheumatoid arthritis (RA) patients with previously treated solid malignancy may be treated as patients without such history. The recommendation is based on limited evidence, and rheumatologists and patients are frequently hesitant to start or continue biologic therapy after a cancer diagnosis. The objective of this study was to describe biologic use in real-world patients with RA following a malignancy diagnosis.Methods.RA patients enrolled in the Corrona registry and diagnosed with solid malignancy with at least 1 followup visit within 12 months after diagnosis were included in this analysis. The proportion of patients continuing or initiating biological/targeted synthetic disease-modifying antirheumatic drug (bDMARD/tsDMARD) after diagnosis was estimated. Median time to initiation of bDMARD/tsDMARD after diagnosis was calculated using the Kaplan-Meier method and the proportion initiating biologic treatment in 6-month time intervals was estimated using the life-table method.Results.There were 880 patients who met inclusion criteria with 2585 person-years total followup time postdiagnosis. Of those, 367 (41.7%) were treated with bDMARD/tsDMARD within 12 months preceding malignancy, of whom 270 (30.7%) were taking such agents at first postdiagnosis visit. Forty-four (5%) switched biologic agents within 36 months and an additional 90 patients (10.2%) started a biologic. The majority of bDMARD/tsDMARD initiations during followup was a tumor necrosis factor inhibitor (TNFi; 53.5%).Conclusion.In real-world practice, nearly one-third of RA patients with a cancer diagnosis were treated with systemic therapy in the immediate visit after malignancy diagnosis and a considerable percentage of malignancy survivors initiated biologic therapy within 3 years. The majority of bDMARD/tsDMARD initiations post-malignancy diagnosis was a TNFi.

scholarly journals Switch rates and total cost associated with apremilast and biologics in biologic-naive patients with psoriatic arthritis

2021 ◽  
Author(s):  
David L Kaplan ◽  
Brian L Ung ◽  
Corey Pelletier ◽  
Chuka Udeze ◽  
Ibrahim Khilfeh ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumor Necrosis Factor ◽  
Real World ◽  
Tumor Necrosis ◽  
Claims Data ◽  
Tumor Necrosis Factor Inhibitor ◽  
Total Cost ◽  
Factor Inhibitor ◽  
Treatment Data ◽  
Necrosis Factor

Aim: Real-world treatment data for psoriatic arthritis are limited. We evaluated switch rates, adherence, and costs for patients initiating apremilast versus tumor necrosis factor inhibitor (TNFi) and interleukin inhibitor (ILi) among biologic-naive psoriatic arthritis patients. Materials & methods: This retrospective analysis used IBM MarketScan claims data to assess treatment switches, adherence and costs. Results: Twelve-month switch rates were significantly lower for apremilast versus TNFi (15.5% vs 26.6%; p < 0.0001) and similar to ILi (15.5% vs 14.0%; p = 0.71). Apremilast initiators had lower total costs versus TNFi and ILi (US$39,854 vs US$57,243 and US$65,687; p < 0.05) and adherence was slightly lower versus TNFi and higher versus ILi. Conclusion: Biologic-naive apremilast initiators had lower switch rates versus TNFi initiators and lower total costs versus TNFi or ILi initiators.

scholarly journals P161 The impact of biologic therapies on Extra-Intestinal Manifestations in Inflammatory Bowel Disease: a multicentre observational study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S239-S240
Author(s):  
F Ferretti ◽  
M C Monico ◽  
R Cannatelli ◽  
M V Lenti ◽  
A Di Sabatino ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Cumulative Incidence ◽  
Adjunctive Therapy ◽  
Biologic Therapy ◽  
Biologic Agents ◽  
Biologic Treatment ◽  
Inflammatory Bowel ◽  
The Impact ◽  
New Onset

Abstract Background A high proportion of Inflammatory Bowel Disease (IBD) patients will develop extraintestinal manifestations (EIMs). Choosing the most appropriate therapeutic strategy among currently available biologics for each patient may often be challenging. Data regarding the effects of gut-selective therapies such as vedolizumab (VDZ) on new-onset and pre-existing EIMs are scarce and often discordant. The main aims of this study were to assess the cumulative incidence of new-onset EIMs and the course of pre-existing EIMs in a large cohort of IBD patients treated with VDZ compared to non-gut selective biologic agents. Methods This multicenter retrospective study collected data of IBD patients on biologic therapy in clinical follow-up at 6 tertiary referral IBD units in Lombardy. Clinical and demographic data of IBD patients were collected. We calculated the cumulative incidence of new-onset EIMs since the introduction of the ongoing biologic therapy, comparing patients on VDZ with patients on non-gut selective therapies. Furthermore, we analyzed the course of pre-existing and new-onset EIMs in these two cohorts of patients. Results Data about 973 IBD patients (624 CD, 339 UC, 10 IBD-U; median age 46 years; 59% males) on biologic therapy were collected. Of them, 215 were on VDZ and 758 were on non-gut-selective agents, with a median treatment duration with the ongoing therapy of 3 years. The overall prevalence of EIMs in this IBD cohort of patients was 19.8% (193/973 patients). The overall cumulative incidence of new-onset EIMs was of 4.1 % (40/973): 13 on VDZ (13/215) versus 27 (27/758) in the non-gut selective group (6% vs 3.6%, p = 0.1). Regardless of the type of biologic agents, the female sex and the duration of the ongoing biologic treatment were statistically associated with a higher risk of developing EIMs. About 17% of IBD patients reported a pre-existing EIM. Compared to non-gut selective therapies, patients on VDZ showed a significantly higher rate of worsening or absence of response (8.1% vs 19.4%, 12/148 vs 7/36, p=0.04). However, in both groups, a modification of the therapeutic protocol has been necessary with the introduction of adjunctive therapy, the switch, or the optimisation of the ongoing biologic therapy (27.8% patients on VDZ versus 25% on non-gut selective therapies, p=0.7). Conclusion Our study suggests that the type of biologic treatment does not affect the risk of new-onset of EIMs. However, in the case of pre-existing EIMs, a subtle higher risk of worsening can be speculated after starting VDZ, even if the proportion of patients who will need adjunctive therapy, the optimisation or switch of the ongoing treatment would be similar between gut-selective and non-gut selective therapies.

scholarly journals Implications of COVID-19 infection on patients with uveitis under biologic treatment

2021 ◽  
pp. bjophthalmol-2020-318577
Author(s):  
Abdulrahman F AlBloushi ◽  
Abdullah M Alfawaz ◽  
Ahmed M Abu El Asrar
Keyword(s):  
Prospective Study ◽  
Behcet’S Disease ◽  
Biologic Therapy ◽  
Behçet's Disease ◽  
Biologic Agents ◽  
Biologic Agent ◽  
Biologic Treatment ◽  
Behcet's Disease ◽  
Common Diagnosis

Background/aimsTo investigate the incidence, severity of COVID-19 infection and the outcomes in patients with uveitis treated with biologic agents during COVID-19 pandemic.MethodsIn this prospective study, we included all patients with uveitis treated with biologic agents and tested for COVID-19 infection between May 2020 and October 2020.ResultsA total of 59 patients were identified. Behçet’s disease was the most common diagnosis (64.4%). Infliximab was the most frequent biologic agent used (61%). Nine (15.3%) patients were tested positive for COVID-19. None of the patients with positive COVID-19 test developed any COVID-19-related symptoms during follow-up. Of the nine patients with positive COVID-19 test, only two patients had uveitis flare-up after the biologic suspension.ConclusionUveitis patients under biologic therapy can be silent carriers for COVID-19.

Biologic Treatment of 4 HIV-Positive Patients: A Case Series and Literature Review

2020 ◽  
pp. 247553032095427
Author(s):  
Bridget Myers ◽  
Quinn Thibodeaux ◽  
Vidhatha Reddy ◽  
Stephanie Chan ◽  
Nicholas Brownstone ◽  
...  
Keyword(s):  
Highly Active Antiretroviral Therapy ◽  
Biologic Therapy ◽  
Case Series ◽  
Biologic Agents ◽  
Severe Psoriasis ◽  
Favorable Effect ◽  
Hiv Positive ◽  
Biologic Treatment ◽  
Highly Active ◽  
Practical Guidelines

Background: The management of psoriatic disease in HIV-positive patients is challenging. Psoriasis in HIV-positive patients is often severe, progressive, and resistant to first- and second-line therapies, including topical treatments, phototherapy, highly active antiretroviral therapy (HAART), and oral retinoids. Other systemic agents used to treat psoriasis, such as methotrexate and cyclosporine, are immunosuppressants and thus many dermatologists may not feel comfortable prescribing them to HIV-positive patients who are already immunocompromised. Biologic agents, which target specific aspects of overactive immune pathways in psoriasis, have revolutionized the management of moderate-to-severe psoriasis. However, data are limited regarding their safety and efficacy in HIV-positive patients. Objective: Report 4 cases of HIV-positive patients managed on biologic therapy and summarize the cases of psoriasis in HIV-positive patients managed on biologic therapy that have been published in dermatologic literature to date. Methods: We searched PubMed and Embase databases using the terms HIV and psoriasis or HIV and psoriatic arthritis combined with one of the 11 biologics currently approved for treating psoriasis. Results: We identified 48 cases of anti-psoriasis biologic therapy (including adalimumab, infliximab, etanercept, ustekinumab, and guselkumab) in HIV-positive patients and added 4. While data are limited, the evidence available suggests biologic agents are safe and efficacious in moderate-to-severe psoriasis and may even have a favorable effect on CD4 and HIV viral counts when used with concomitant HAART. Conclusion: Further research would be helpful to establish practical guidelines for the use of anti-psoriasis biologic therapy in the HIV population, including that of newer agents.

scholarly journals Persistence with biologic therapy and associated costs of patients with Inflammatory Bowel Disease: A German retrospective claims data analysis

2021 ◽  
Author(s):  
Joerg Mahlich ◽  
Melanie May ◽  
Chiara Feig ◽  
Vincent Straub ◽  
Renate Schmelz
Keyword(s):  
Data Analysis ◽  
Inpatient Treatment ◽  
Claims Data ◽  
Biologic Therapy ◽  
Biologic Agents ◽  
Treatment Costs ◽  
Biologic Agent ◽  
Biologic Treatment ◽  
Inflammatory Bowel ◽  
Claims Data Analysis

Abstract Background In recent years biologic agents became a relevant and promising treatment option for inflammatory bowel diseases (IBD). However, high treatment costs and moderate remission rates lead to a high interest in treatment persistence and corresponding economic consequences. Method A retrospective health claims data analysis was conducted including biologic naïve patients diagnosed with IBD between 2013 and 2018. Observation points were at 12 and 18 months of follow-up, starting from the first biologic prescription. Non-persistence was defined as either no further prescription or prescription of another biologic agent within the days of supply per original prescription. Biologic agents included were Adalimumab, Golimumab, Infliximab, Ustekinumab and Vedolizumab. Results In total, 1,444 patients with IBD were included in this analysis, mostly treated with Adalimumab (46.9%) and Infliximab (39.9%) as their first biologic treatment. After 12 months 72.2% of patients were still persistent with their initial biologic treatment with the highest shares for Infliximab (74%) and Vedolizumab (72.4%). 27.8% of patients were non-persistent, mostly due to a switch of biologic agent (75.8%). Cox-Regression identified sex, hospitalizations and simultaneous prescriptions of corticosteroids and immunomodulators as risk factors for non-persistence. Treatment costs per year were approximately 3,000€ higher for non-persistent patients (27,146€) than for persistent patients (23,839€), mostly due to inpatient treatment costs. Conclusion The persistence of biologic therapy in this study was rather high at 72% after 12 months, while non-persistence was mostly due to switches to other biologic agents. Lack of persistence is associated with increased cost, mostly due to non-biologic medication and inpatient treatment.

scholarly journals AB0809 HOW WELL ARE BIOLOGICS RETAINED IN PSORIATIC ARTHRITIS - A REAL WORLD STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1706.1-1706
Author(s):  
I. Jawad ◽  
M. K. Nisar
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Real World ◽  
Biologic Therapy ◽  
Health Economy ◽  
Nice Guidelines ◽  
Drug Survival ◽  
Gi Symptoms ◽  
Conventional Dmards ◽  
Significant Difference

Background:Biologics have led to a sea change in the management of psoriatic arthritis (PsA) with unprecedented improvement in the signs, symptoms and radiographic damage, resulting in improvement in functionality and quality of life. However longitudinal data for their retention and tolerability is sparse.Objectives:Our objective was to evaluate real-world biologic therapy duration and reasons for discontinuing treatment.Methods:We conducted a retrospective analysis of our PsA electronic register from 1994 up to and including April 2019 at our university teaching hospital. We had access to full patient records including details on co-morbidities, drugs and disease management.Results:335 patients were identified with PsA. 58% of them were female with mean age of 46 yr (13-81). 113 (33.7%) patients had been treated with a biologic with 105 (93%) continuing at the time of analysis. 60 individuals were prescribed combination therapy with DMARDs. Mean age was 43.3 years (13-81) with 56% women. The biologics sample was ethnically diverse including 80% White Caucasian patients, 17% Asian and others (3%). Significant co-morbidities included cardiovascular disease (18.6%) and diabetes (4.4%). Eight different biologics were in use with adalimumab being the most prescribed (67%).35 (30.9%) patients had stopped biologics at some point with 76 episodes of cessation. 6% of our sample had discontinued two or more biologic treatments. The mean duration before biologic therapy was discontinued was 18.2 months (8 days to 9.5 years), which was almost twice as long as the average period before discontinuing a DMARD (9.9 months). Main reasons for stopping treatment included 23% each due to GI symptoms, neurological causes, cutaneous symptoms and other side effects. The remaining 8% reported fatigue as the reason for stopping therapy.Conclusion:To our knowledge this is the first dedicated retrospective review of a large real world PsA cohort comparing drug survival and tolerability of biologics against DMARDs. Biologic therapies are well tolerated in psoriatic arthritis. There is no significant difference amongst various modes of action. Over a quarter of the patients discontinue the drug owing to intolerance with mean drug survival of 18 months. In contrast nearly two-thirds were intolerant of DMARDs and stopped within ten months. Thus both the rate and duration of biologic retention is significantly better than conventional DMARDs. This has significant economic impact as NICE guidelines require an adequate trial of two DMARDs for six months prior to advanced therapy. However, this approach is unlikely to be cost effective as the disease progresses whilst patients struggle with DMARDs prescription and thus delay biologics which are more likely to be tolerated and retained longer. Hence there is an urgent need to review NICE guidelines to allow earlier employment of biologics in the treatment paradigm with significant benefits to both patients and the health economy.Disclosure of Interests:Issrah Jawad: None declared, Muhammad Khurram Nisar Grant/research support from: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Consultant of: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB, Speakers bureau: Muhammad Nisar undertakes clinical trials and received support (including attendance at conferences, speaker fees and honoraria) from Roche, Chugai, MSD, Abbvie, Pfizer, BMS, Celgene, Novartis and UCB

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