The efficacy and safety of omalizumab for the treatment of severe persistent allergic asthma have been demonstrated in randomised controlled clinical trials. However, there are limited “real world” data on its effects on healthcare resource utilisation or health-related quality of life (QoL) in UK clinical practice.
Methods
A 10 centre retrospective observational study (APEX) compared 12 months pre- vs 12 months post-omalizumab initiation in patients aged =12 years with severe persistent allergic asthma. All patients received =1 dose of omalizumab. Patients who had received omalizumab in a clinical trial were excluded. Hospital records were reviewed to obtain data on hospital resource use and routinely used QoL measures for example, Asthma Quality of Life Questionnaire (AQLQ) at baseline (pre-omalizumab), 16 weeks and up to 12 months following omalizumab initiation.
Results
Mean in-patient hospital admissions fell by 61% from 1.30 to 0.51 (p<0.001) and mean in-patient bed days fell by 70% from 9.10 to 2.74 (p<0.001) per patient. In the subgroup of patients hospitalised for asthma in the 12 months pre-omalizumab (n=81), mean in-patient hospital admissions fell by 70% from 2.19 to 0.65 (p<0.001) and mean in-patient bed days fell by 74% from 14.86 to 3.83 (p<0.001) per patient. Similarly, mean Accident and Emergency department attendances fell by 70% from 1.52 per patient in the 12 months pre-omalizumab to 0.46 in the 12 months post-omalizumab (p<0.001). Other resource use, such as outpatient attendances (excluding visits made solely for omalizumab administration), nurse appointments and telephone consultations remained unchanged following omalizumab initiation. QoL data were not available for all patients at every time point. However, where data were available, mean AQLQ scores increased from 3.09 at baseline to 5.01 at 16 weeks (n=90) and to 5.22 at 12 months (n=29).
Conclusions
Treatment with omalizumab is associated with a clinically and statistically significant reduction in unplanned hospital resource utilisation and improvements in patients9 QoL.
The fixed, progressive disability associated with late Multiple Sclerosis (MS) is known to have a major impact on patients and their families, but the impact of relapse earlier in the disease course is less well documented, particularly from the patient׳s perspective. This study aimed to understand the effects of relapse for people with MS (PwMS), focussing on the years immediately after starting disease modifying therapy (DMT) when experience of a relapse may particularly influence a patient׳s opinions of their disease and its therapy.This was a multi-centre, retrospective, observational research study, recruiting patients from 7 UK NHS Hospital Trusts. Consenting patients with relapsing-remitting MS (RRMS), who had started a DMT more than 36 months before screening, were sent a study questionnaire. Data on MS relapses and treatments over 3 years were collected simultaneously from medical records.One hundred and three patients completed the questionnaires. Relapses were under-reported to health care professionals, with 28% of respondents failing to report their most recent attack and 46% declaring they had failed to report an attack in the past. During their most recent relapse, 67% of those in paid employment reported taking time off sick, 48% reduced working hours temporarily, and 41% worked reduced hours and took time off sick. Sixty-six percent required additional support to undertake routine daily tasks during their most recent relapse. A range of effects of relapse which cannot be measured in financial terms were also reported, including effects on physical abilities, mental health and family roles and relationships.This contemporary UK-based study provides an insight into the experience of relapse early in the treatment of RRMS from the patient perspective. The comparison of documented patient reported relapses reveals some deficiencies in the recording of relapses which is important to address in view of the reported impact of individual relapses, and emphasises relapse reduction as a worthy treatment aim.
NHS Stop Smoking Services provide various options for support and counselling. Most services have evolved to suit local needs without any retrospective evaluation of their efficiency. Three local service evaluations were carried out at Bournemouth & Poole Teaching Primary Care Trust (PCT) (PCT1), NHS South East Essex (PCT2) and NHS Warwickshire (PCT3) to describe the structure and outcomes associated with different services. Standardised interviews with key personnel in addition to analysis of data from 400 clients accessing the service after 1st April 2008 in each PCT. The PCTs varied in geography, population size and quit rate (47%-63%). Services were delivered by PCT-led specialist teams (PCT1), community-based healthcare providers (PCT3) and a combination of the two (PCT2) with varying resources and interventions in each. Group support resulted in the highest quit rates (64.3% for closed groups v 42.6% for one-to-one support (PCT1)). Quit rates were higher for PCT (75.0%) v GP (62.0%) and pharmacist-delivered care (41.0%) where all existed in the same model (PCT2). The most-prescribed therapy was NRT (55.8%-65.0%), followed by varenicline (24.5%-34.3%), counselling alone (6.0%-7.8%) and bupropion (2.0%-4.0%). The results suggest that service structure, method of support, healthcare professional involved and pharmacotherapy all play a role in a successful quit. Services must be tailored to support individual needs with patient choice and access to varied services being key factors.
Previous studies with anti-TNF drugs1–3 for Crohn9s disease (CD) showed a reduction in cost by reducing hospitalisations, examinations under anaesthetic (EUA) and diagnostic procedures. However no study has looked at the effect of anti-TNF drug dosing schedule on outcomes and resource use.
Methods
Retrospective study using patient records, in 5 UK hospitals. Consenting patients aged>18 with a diagnosis of CD who had started any anti-TNF drug >1 year prior to study, with records for >2 years pre-anti-TNF were included. Data were collected for 2 years pre-anti-TNF and 1 year post-anti-TNF initiation on hospital resource use associated with CD. Outcomes measured were change in steroid use, rates of surgery and change in disease state at 1 year versus baseline.
Results
Of 142 patients in the study (61% female) 121 (85%) started anti-TNF drug in 2005–2009. The prescribing pattern changed from 78% episodic dosing (ED) in 2003 to 79% maintenance dosing (MD) in 2009. Anti-TNF was started a median of 8.7 years (IQR 12.6 years) after diagnosis, with patient median age at initiation 34 years (IQR 18 years). At 1 year, 77% of patients had improved disease, 12% worse and 11% remained the same. Steroids were stopped in 23% and reduced in 23% at 1 year; more in the MD group (32%) than in the ED group (12%). Rates of major abdominal surgery were similar pre-anti-TNF and post-anti-TNF (0.06 in Y-1 and 0.10 in Y+1). Overall, NHS resource use was similar pre-anti-TNF and post-anti-TNF, for all visit types except day case visits which increased (mean 0.7/year pre vs 5.9/year post) for infliximab infusions. In the MD group there was a NS trend to fewer admissions (mean 0.65/year pre vs 0.42/year post), bed days (4.9 vs 3.6/year), OP visits (7.5 vs 6.4), EUA (1.1 vs 0.8) and A&E visits (0.2 vs 0.1) post-anti-TNF and 72% of MD patients had reduced non-drug direct costs in the post-anti-TNF year.
Conclusion
In this study CD of patients treated with anti-TNFs improved and steroid use was reduced, particularly with MD but it did not show the reduction in resource use or major surgery seen in previous work.1–3 Results were affected by two very high cost patients, highlighting variability in disease course. Prospective studies are needed to fully explore differences between ED and MD. However, this study suggests that outcomes and costs may be better with MD than ED, supporting latest NICE guidance.4
The aim of this study was to evaluate the "real world" effects of the monoclonal antibody omalizumab (OMB) when used to treat severe persistent allergic asthma in UK clinical practice.A 10-center retrospective observational study was carried out to compare oral corticosteroid (OCS) use and exacerbation frequency in 12 months pre- versus post-OMB initiation in 136 patients aged ≥12 years with severe persistent allergic asthma. All patients received ≥1 dose of OMB. Patients who had received OMB in a clinical trial were excluded. Data were obtained from hospital and if necessary general practitioners' (GPs') records on OCS use, lung function, hospital resource use, and routinely used quality of life (QoL) measures at baseline (pre-OMB), 16 weeks, and up to 12 months post-OMB initiation.Mean total quantity of OCS prescribed per year decreased by 34% between the 12 months pre- and post-OMB initiation. During the 12 months post-OMB initiation, 87 patients (64%) stopped/reduced OCS use by 20% or more and 66 (49%) stopped OCS completely. Mean percent predicted forced expiratory volume in one second (FEV(1)) increased from 66.0% at baseline to 75.2% at week 16 of OMB therapy. The number of asthma exacerbations decreased by 53% during the 12 months post-initiation. Accident and emergency visits reduced by 70% and hospitalizations by 61% in the 12 months post-OMB initiation.This retrospective analysis showed a reduction in exacerbations and improved QoL as per previous studies with OMB. However, the total reduction in annual steroid burden and improved lung function in this severely ill group of patients taking regular or frequent OCS is greater than that seen in previous trials.
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