P210 INDICATORS OF ASTHMA EXACERBATION BEFORE INITIATION OF BIOLOGIC THERAPY: A REAL-WORLD EXPERIENCE

2019 ◽  
Vol 123 (5) ◽  
pp. S35
Author(s):  
E. Pennington ◽  
C. Camargo ◽  
N. Hanania ◽  
F. Holguin ◽  
R. Tubman ◽  
...  
2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1706.1-1706
Author(s):  
I. Jawad ◽  
M. K. Nisar

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


2019 ◽  
Vol 46 (11) ◽  
pp. 1438-1444 ◽  
Author(s):  
Dimitrios A. Pappas ◽  
Sabrina Rebello ◽  
Mei Liu ◽  
Jennifer Schenfeld ◽  
YouFu Li ◽  
...  

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.


Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Shivanee Vigneswaran ◽  
Megan Galloway ◽  
Samuel Hanlon ◽  
Aoife Tynan ◽  
Animesh Singh

Abstract Background Biologic drugs have revolutionised the management of many rheumatological diseases with remission or low disease activity now the realistic targets for treatment. However, given the chronic nature of most rheumatological disease and the need for long term treatment, there has been a significant increase in the cost associated with disease treatment. The advent of biosimilars offers an attractive target in reducing drug costs for payers. Biosimilar medications are thought to be equally efficacious as originator drugs. Real world data in adalimumab biosimilar switching is limited. In this audit we aim to examine the real-world outcomes from switching from originator Humira to biosimilar Amgevita in a London teaching hospital. Methods A list of all adult rheumatology patients on Amgevita was obtained through pharmacy records. All patients had been switched from Humira to Amgevita from February 2019. Using clinic letters and an in-house biologics database, data was collected on the underlying disease and the date of switch. Outcomes reviewed were disease activity scores pre and post switch, documented side effects and flare of disease activity following switch including decision to revert to originator Humira or change treatment. Results There was a total of 289 adult patients on Humira who switched to Amgevita. Of these patients, 28 in total discontinued treatment - 13 with rheumatoid arthritis, 10 with psoriatic arthritis and 5 with ankylosing spondylitis. 22 had to be switched back to Humira, with a further 4 patients approved to switchback and awaiting to restart. Two additional patients were switched to alternative biologic therapy due to inefficacy. A further 3 patients refused to switch onto Amgevita. Sixteen patients had documented flares, with one requiring admission and ten requiring local or systemic corticosteroid therapy to control activity. Seven patients had documented side effects which included chest pain, headache, rash and site reactions and one patient developed shingles post switch. Conclusion A total of 9.6% of patients switched to Amgevita had disease flare or side effects resulting in a switchback to Humira or alternative biologic therapy. For a biosimilar to be approved, efficacy and safety profiles needs to be comparable to the originator biological therapy and usually looks at two treatment naïve groups, rather than direct switch. Thereby, data on switches in therapy is limited. One systematic review looking at 11,053 patients with inflammatory arthritis treated with Etanercept and switched to Benepali, found 768 reverting to original therapy giving a lower total of 6.9%. We find that although no previous data of Amgevita, our figure of 9.6% appears high in the context of previously controlled inflammatory disease with Humira. Disclosures S. Vigneswaran None. M. Galloway None. S. Hanlon None. A. Tynan None. A. Singh None.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S251-S251
Author(s):  
T Hisamatsu ◽  
A Yoon

Abstract Background Biologic therapy in Crohn’s disease (CD) has significantly improved treatment outcomes. Still, providing an optimal care for individual patient in real-world is complex. We report the real-world treatment decisions between biologics and systemic corticosteroids (SCS) and associated factors in newly diagnosed CD in Japan. Methods Patients with CD diagnosis (Index) and at least one CD therapeutic agent prescribed between 2006 and 2019 were screened from the JMDC database. JMDC is a health claims database where various sized (small to very large) companies’ employees and their dependents are enrolled. Subjects with a minimum 12-month CD-diagnosis-free enrolment period up to the Index, and a minimum 12-month observational period after the Index were included in the analysis. Subjects were categorised into 2 groups (A: without biologics, B: with biologics) based on their first-year treatment, and then further into 4 groups: SCS without biologics (A1), No SCS nor biologics (A2), Biologics with no prior SCS (B1), Biologics with prior SCS (B2). Results 859 subjects were included. 38.4% (B: n=330/859) initiated biologics within a year since diagnosis (Table 1). Among them, 73.3% (B2: n=242/330) initiated biologics without prior SCS, so-called a top-down approach. Among the rest who were not treated with biologics within the first year, 27.2% (A1: n=114/529) received SCS. B were 7.5 years younger on average and had a higher rate of perianal symptoms (43.0%) compared to A (22.9%). Trend analyses showed that the rates of biologic adoption in the first year have been relatively stable over a decade since 2008 to 2019 (Table 2). Conclusion Real-world treatment decisions in newly diagnosed CD were investigated, and perianal symptoms were strongly associated with biologic therapy. Biologic adoption rates in CD seemed higher and faster in Japan compared to Europe. According to a Danish study reported by Alulis et al. (2020), 28.5% of CD patients received biologics at some point during the whole study period, of which 46.2% received within a year. These figures suggest that 13.2% of newly diagnosed CD were treated with biologics within the first year in the Danish study compared to 38.4% in our study.


Author(s):  
Ciro Romano ◽  
Sergio Esposito ◽  
Roberta Ferrara ◽  
Giovanna Cuomo

2016 ◽  
Vol 75 (Suppl 2) ◽  
pp. 193.2-193
Author(s):  
C.E. Lampropoulos ◽  
P. Orfanos ◽  
M. Manoussakis ◽  
A. Tzioufas ◽  
H.M. Moutsopoulos ◽  
...  

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 333.1-333
Author(s):  
A. Mirza ◽  
M. K. Nisar

Background:Methotrexate (MTX) is the bed rock of inflammatory arthritis management. However intolerance is a major limiting factor for drug optimisation and retention. There is data to suggest that subcutaneous (SC) MTX is tolerated better and is now being recommended in several guidelines including ACR’s. It is less clear though whether this strategy is effective in those where oral preparation is inefficacious and its potential to avoid escalation to biologic therapy.Objectives:Our aim was to analyse the reasons for switching to SC formulation in a real world setting, clinical outcomes achieved and proportion requiring biologic prescription.Methods:We undertook a retrospective survey of all patients prescribed SC MTX in a large university teaching hospital between 1983 and Apr 2019. We had access to full patient records including details on co-morbidities, drugs and disease management. We analysed demographics, reasons for SC MTX initiation, clinical outcomes and impact on biologic prescription.Results:352 patients were identified during the study period. The mean age of the cohort was 54 yrs (3-87). 192 (70%) were women. 260 (74%) were Caucasian, 64 (18%) Asian, 21 (6%) Afro-Caribbean and remaining of other ethnicity. Two most common diagnoses were RA [n=243 (69%)] and pSpA [n=66 (18%)]. Average disease duration was 74 months (11-324) with mean of three comorbidities (0-11).284 (80%) had switched from oral to SC MTX. 137 (49%) stopped oral MTX due to side effects. Mean duration of oral MTX prior to switching was 26 months (0.25-167). Follow up period for SC MTX ranged from two to 132 months (mean 29) until the data cut-off date of Apr 2019. 103 (29%) patients progressed to biologic therapy.Amongst RA patients, DAS28 improved from mean 4.16 (0.63-8.06) to 2.83 (0.14-7.32) following the switch. pSpA cohort’s mean TJC and SJC improved from mean seven (0-42) and two (0-26) to two (0-25) and one (0-6) respectively.Conclusion:Our study confirms that SC MTX is an effective solution irrespective of whether oral MTX is inefficacious or intolerable. This applies to people with both RA and pSpA. In accordance with prior published data, our findings support the utility of SC MTX for those intolerant of enteral option. Additionally, it shows that even in instances where oral MTX was ineffective, a switch to SC formulation achieved low disease activity despite multi-morbidity, long disease course and protracted oral MTX exposure. This intervention also prevented over two-thirds of patients progressing to biologic therapy with significant financial savings. SC MTX therefore remains a durable strategy with excellent disease outcomes and confers substantial economic benefits to healthcare.Disclosure of Interests:None declared


Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Zoe Rutter-locher ◽  
Yik Long Man ◽  
Lydia Marsh ◽  
Scott Mercer ◽  
Bina Menon ◽  
...  

Abstract Background/Aims  Biologic therapy and treat to target have significantly improved patient outcomes and we now have a proportion of patients on biologic therapy who remain in clinical remission. NICE guidance suggests “cautiously reducing drug doses or stopping drugs in those who have maintained the treatment target”. Despite this guidance, little is known about current clinical practice of biologic tapering in UK rheumatology centres. We aimed to illustrate current practice and success rates in biologic tapering in a real-world setting in patients with rheumatoid arthritis (RA), psoriatic arthritis (PSA) and ankylosing spondylitis (AS). Methods  We identified patients who were potentially suitable for biologic tapering 1 week prior to their follow up appointment using the following criteria - any anti-TNFα biologic ≥ 1 year, RA patients (DAS28 CRP<3.2, CRP normal), PSA patients (no swollen joints, CRP normal, no extra-articular manifestations), AS patients (BASDAI<4, CRP normal). We then analysed how many patients were successfully tapered at one year. Tapering schedule was decided by the supervising rheumatologist. Results  From December 2018 to February 2019, 66 patients were identified as being suitable for biologic tapering. 3 patients did not attend and were excluded from further analysis. Tapered group: 20 (32%) patients were tapered. Based on the retrospective review of clinic letters, the “tapering schedule” was inconsistent and the information provided to patients if they flared was also inconsistent - 9 (45%) patients were advised to return to their normal dose and only 1 (5%) patient was advised to contact the helpline. After 12 months of follow up, 11 (55%) patients remained on the tapered dose, 7 (35%) patients returned to their prior dose and 2 (10%) patients were lost to follow up. Non-tapered group: 43 (68%) patients were not tapered. The reasons for not tapering were divided into 6 broad categories: active disease (n = 15, 35%), patient choice (n = 5, 12%), DMARD was tapered instead (n = 5, 12%), discuss at next visit (n = 3, 7%), reason not mentioned (n = 12, 28%), other (n = 3, 7%) Conclusion  This Quality Improvement Project has highlighted the inconsistencies in biologic tapering in a UK real-world setting. In response to this inconsistency, we have developed a departmental guideline which provides stringent criteria to identify patients at lowest risk of flaring and standardises a tapering schedule and clinical pathway. We also created a patient information leaflet that could be distributed. Only half of the patients remained on the tapered dose after 1 year, suggesting a significant proportion of patients flare following dose reduction. However, our findings may be limited by small sample size. National guidance and a thorough audit based on this guidance is welcomed. Disclosure  Z. Rutter-locher: None. Y. Long Man: None. L. Marsh: None. S. Mercer: None. B. Menon: None. A. Cope: None.


Sign in / Sign up

Export Citation Format

Share Document