scholarly journals POS0632 THE LONGITUDINAL ASSOCIATIONS OF METHOTREXATE AND BIOLOGIC USE ON HOSPITAL ADMISSION FOR RHEUMATOID ARTHRITIS PATIENTS IN WESTERN AUSTRALIA POPULATION (1995- 2014)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 554.1-554
Author(s):  
K. Almutairi ◽  
J. Nossent ◽  
D. Preen ◽  
H. Keen ◽  
C. Inderjeeth

Background:Rheumatoid arthritis (RA) carries a substantial burden for patients and society in terms of morbidity, enduring disability, and costs [1]. The Australian Pharmaceutical Benefits Scheme (PBS) has subsidised biological disease-modifying anti-rheumatic drugs (B-DMARDs) since 2003 [2].Objectives:We examined the impact of B-DMARDs availability on RA hospitalisation rate in the Western Australia (WA) population pre- and post- B-DMARDs introduction to the PBS (1995-2002 and 2003-2014).Methods:Population PBS dispensing data for WA of DMARD were obtained and converted to defined daily doses (DDD)/1000 population/day using the WA population census. RA inpatient records were extracted from the WA Hospital Morbidity Data Collection using ICD-9 codes 714 and ICD-10 codes M05.00–M06.99). Principal component analysis (PCA) was applied to determine the relationship between DMARDs use and RA hospital admission rates.Results:There was a total of 17,125 patients who had 50,353 admissions with a diagnostic code for RA during the study period. DMARD use for RA rose from 1.45 to 3.19 DDD/1000 population/day over 1995-2014 (Figure 1). In 1995-2002, the number of RA admissions fell from 7.9 to 2.6 per 1000 hospital separations, then dropped further from 2.9 to 1.9 per 1000 hospital separations in 2003-2014. Based on PCA analysis, conventional DMARDs (methotrexate) and B-DMARDs dispensing had an inverse association with hospital admissions for RA.Conclusion:The increased availability of conventional and biological DMARDs for RA was associated with a significant decline in hospital admissions for RA patients in WA.References:[1]Boonen A, Severens JL (2011) The burden of illness of rheumatoid arthritis. Clin Rheumatol 30:3-8.[2]Medicare Australia (2020) Pharmaceutical Benefits Schedule statistics. http://medicarestatistics.humanservices.gov.au/statistics/pbs_item.jsp.Figure 1.The hospital separations and total drugs use patterns of RA in 1995-2014 in Western Australia.Acknowledgements:Supported by an Australian Government Research Training Program PhD Scholarship at the University of Western Australia.Disclosure of Interests:Khalid Almutairi: None declared, Johannes Nossent Speakers bureau: Janssen, David Preen: None declared, Helen Keen Speakers bureau: Pfizer Australia, Abbvie Australia, Charles Inderjeeth Speakers bureau: bureau: Eli Lilly

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 373.2-374
Author(s):  
K. Almutairi ◽  
J. Nossent ◽  
D. Preen ◽  
H. Keen ◽  
C. Inderjeeth

Background:Rheumatoid arthritis (RA) represents a substantial burden on patients and society in terms of morbidity, enduring disability, and medical expenses (1). RA prevalence is poorly described in Australia, and linked health datasets can provide a more meaningful picture for RA epidemiology in the Australian population.Objectives:To describe the period prevalence rate of RA patients per 1000 hospital separations coded as RA primary or secondary diagnosis in Western Australia (WA) hospitals between 1995 and 2014.Methods:We extracted data on all patients identified in the WA Hospital Morbidity Data Collection between 1995 and 2014, with the International Classification of Diseases (ICD) codes for RA (ICD 10 M05.00–M06.99, and the corresponding ICD 9 codes). We estimated period prevalence rates per 1000 hospital separations and annual average percentage changes, with the total number of hospital separations each year.Results:A total of 17,125 patients were admitted to WA hospitals with a diagnostic code for RA over the study period (1995-2014). The total number of hospital separations for RA patients was 50,353, indicating an average of three hospital separations per patient over twenty years. The RA prevalence was 3.4 per 1000 separations over the study period, with a -2.89% annual average decrease since 1995.Conclusion:These data demonstrate that hospitalisation for RA has decreased considerably in WA over the last two decades. As this decrease roughly coincides with the introduction of biological drug treatment for RA, the reduced need for hospital admission is likely due to improvements in RA management.References:[1]Uhlig T, Moe RH, Kvien TK (2014) The burden of disease in rheumatoid arthritis. Pharmacoeconomics 32:841-851. doi:10.1007/s40273-014-0174-6Acknowledgements:Khalid Almutairi was supported by an Australian Government Research Training Program PhD Scholarship at the University of Western Australia.Disclosure of Interests:Khalid Almutairi: None declared, Johannes Nossent Speakers bureau: Janssen, David Preen: None declared, Helen Keen Speakers bureau: Pfizer Australia, Abbvie Australia, Charles Inderjeeth Speakers bureau: Eli Lilly


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mohammad H. Al-Qahtani ◽  
Abdullah A. Yousef ◽  
Bassam H. Awary ◽  
Waleed H. Albuali ◽  
Mohammed A. Al Ghamdi ◽  
...  

Abstract Background The Emergency Repartment (ER) is one of the most used areas in healthcare institutions. Problems with over utilisation and overcrowding have been reported worldwide. This study aims at examining the characteristics of paediatric ER visits, the rate of hospital admissions and its associated predictors at King Fahd Hospital of the University in the Eastern Province of Saudi Arabia. Methods This is a retrospective, medical record-based study. Variables included gender, age group, nationality, complaints, Triage level, shifts and seasons. Descriptive statistics were reported as frequencies/percentages. P-values were obtained through a Chi-Squared test while unadjusted and adjusted odds ratios were estimated by binary logistic regression, where admission was considered as the outcome. Results The total number of paediatric patients included was 46,374, and only 2.5% were admitted. Males comprised 55.4% while females comprised 44.6%. The most common age group were toddlers, and 92.4% of the total sample were Saudis. The most common complaint was fever (26.9%) followed by respiratory symptoms (24.9%). Only 7 patients (0.02%) were classified as triage I (Resuscitation), and most were triage IV (Less urgent) (71.0%). Most visits occurred during the winter months. Adjusted ORs showed that neonates had higher odds of admission (OR = 3.85, 95%CI = 2.57–5.76). Moreover, those presenting with haematological conditions showed an OR of 65.49 (95%CI = 47.85–89.64), followed by endocrine conditions showing an OR of 34.89 (95%CI = 23.65–51.47). Triage I had a very high odds of admission (OR = 19.02, 95%CI = 2.70–133.76), whereas triage V was associated with a very low odds of admission (OR = 0.30, 95%CI = 0.23–0.38). Conclusions A low rate of hospital admission was found in comparison with other rates worldwide. This was mostly attributed to an alarmingly high number of non-urgent ER visits. This further emphasises the problem with improper use of ER services, as these cases should be more appropriately directed towards primary healthcare centres. Further studies to examine the impact of prioritising patients in the ER based on the identified predictors of hospital admission, in addition to the standard triage system, are suggested.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 498.3-499
Author(s):  
P. H. Hsieh ◽  
C. Geue ◽  
O. Wu ◽  
E. McIntosh

Background:Comorbidities are prevalent in patients with rheumatoid arthritis (RA) and associated with worse outcomes as well as higher economic burden. Little is known about the impact of multimorbidity on the direct and indirect costs of RA. Evidence of the incremental scale of these multimorbidity costs will usefully inform RA interventions and policies.Objectives:The aim of this study was to describe how multimorbidity impacts on the cost-of-illness, including direct and indirect costs, in patients with RA.Methods:The Scottish Early Rheumatoid Arthritis (SERA) is a registry of patients newly presenting with RA since 2011. It contains data on patient characteristics, clinical outcomes, health-related quality of life, and employment status data. These data were linked to routinely recorded hospital admissions and primary care prescribing data. Direct costs were estimated by applying relevant unit costs to healthcare resource use quantities. Indirect cost estimates were obtained from information on employment status and hospital admissions, valued by age and sex specific wages. Two-part models (probit followed by generalized linear model) were used to estimate direct and indirect costs, adjusting for age, gender, and functional disability. The Charlson Comorbidity Index (CCI) score was calculated using patient ICD-10 diagnoses from hospital records. The number of comorbidities was categorized into “RA alone”, “single comorbidity” and “multimorbidity (>1 comorbidity)”.Results:Data were available for 1,150 patients, 65.7% were female and a mean age of 57.5±14 years. The majority of patients only had RA (54.1%), followed by a single comorbidity (23.4%) and multimorbidity (22.5%). Annual total costs were significantly higher for patients with multimorbidity (£6,669 95% CI £4,871-£8,466; OR 11.3 95% CI 8.14-15.87) and for patients with a single comorbidity (£2,075 95% CI £1,559-£2,591; OR 3.52 95% CI 2.61-4.79), when compared with RA alone (£590). The excess costs were mainly driven by direct costs (£6,281 versus £1,875 versus £556). Although the difference in indirect costs between patients with multimorbidity and a single comorbidity were not statistically significant (£1,218 versus £914, p=0.11), patients with multimorbidity were associated with significantly higher costs than those with RA only (£594, p<0.01).Conclusion:The presence of comorbidity contributes significant excess to both direct and indirect costs among RA patients. In particular, patients with multimorbidity incurred substantially higher direct costs than those with a single comorbidity or RA only.Acknowledgements:The study analysed the data from the Scottish Early Rheumatoid Arthritis (SERA) study with a linkage to routinely recorded health data from Information Service Division, National Service Scotland. We would like to thank all the patients, clinical and nursing colleagues who have contributed their time and support to the study, the SERA steering committee for the approval, and Allen Tervit from the Robertson Centre for Biostatistics, University of Glasgow for the timely technical supports.Disclosure of Interests:Ping-Hsuan Hsieh: None declared, Claudia Geue: None declared, Olivia Wu Consultant of: OW has received consultancy fees from Bayer, Lupin and Takeda outside the submitted work., Emma McIntosh: None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 559.2-560
Author(s):  
V. Rivera Teran ◽  
S. Sicsik ◽  
D. Vega-Morales ◽  
F. Irazoque-Palazuelos ◽  
D. Miranda ◽  
...  

Background:Rheumatoid arthritis (RA) is the most common autoimmune disease. Older patients treated with biologic DMARDs (bDMARDs) are at a significantly greater risk of adverse effects (AEs) [1]. However, the rate of drug discontinuation because of adverse effects caused by bDMARDs has not differed in elderly compared to younger patients in different registries.Objectives:Determine if drug discontinuation of bDMARDs differs by age in patients with rheumatoid arthritis in the Mexican Adverse Events Registry (BIOBADAMEX).Methods:BIOBADAMEX is a Mexican ongoing cohort of patients using bDMARDs since 2016. In this analysis we included all patients with diagnosis of RA with at least two assessments. Survival on bDMARDs was estimated using Kaplan-Meier analysis. Predictors of discontinuation, including age older than median age in the sample were investigated by Cox regression analyses.Results:Among 743 patients in the registry, 497 had RA diagnosis, from which, 214 had at least two assessments. At baseline, patients had a median (IQR) age of 53.4 (45-61) years old, median disease duration of 10.7 (6-17) months and median DAS28 of 4.7 (3-6). Conventional DMARDS were used by 185 (87%) patients and 94 (44%) patients used corticosteroids. Comorbidities were present in 194 (91%). The most common bDMARDs received at baseline were abatacept 59 (27%), tocilizumab 45(21%), adalimumab 31 (15%) and certolizumab 30 (14%). At the time of analysis, the median bDMARDs treatment duration was 21.0(13-34) months, 128 (59%) had discontinued treatment, 66 for inefficacy, 32 for adverse events and 30 for others. Fig 1 shows discontinuation rate curves in patients younger and older than median age. Cox proportional-hazards demonstrated no significant differences regarding age older than median age (HR 1.1, 95% CI 0.8-1.4, p=0.7), female sex (HR 1.2, 95% CI 0.7-1.9, p=0.44), use of corticosteroids (HR 1.2, 95% CI 0.9-1.6, p=0.20), comorbidities (HR 0.9, 95% 0.6-1.5, p=0.78), DAS28 (HR 0.9, 95% 0.9-1.1, p=0.93) or other factors.Figure 1.Discontinuation rate curves in patients younger and older than median age (< 53.4 and >=53.4 years old)Conclusion:This analysis did not show a role of age on discontinuation of bDMARDs in Mexican RA patients. Further longitudinal analyses will be performed including more patients to assess retention rate of bDMARDs and identify predictive variables of discontinuation in Mexican population.References:[1]Akter R, et al. Can Geriatr J. 2020 May 1;23(2):184-189.[2]Ikari Y, et al. Medicine (Baltimore). 2020 Dec 24;99(52):e23861.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 461-461
Author(s):  
M. V. Sokolova ◽  
J. Rech ◽  
M. Hagen ◽  
G. Schett ◽  
U. Steffen (née Harre)

Background:Understanding key mechanisms of flare development and sustained remission is one of the acute goals in modern rheumatology. Anti-citrullinated protein antibodies (ACPA) are the most abundant and specific autoantibodies in rheumatoid arthritis (RA) patients. However, the impact of ACPA of IgA isotype is poorly defined. IgA ACPA were previously shown to have a higher percentage of IgA2 in comparison to total IgA; and a correlation between IgA2% ACPA with the DAS28 score was observed in a previous study [1]. Of note, IgA1 and IgA2 were shown to exhibit different effector functions, with IgA2 being pro-inflammatory, which might be the background for its role in RA [1].Objectives:We aimed to investigate, whether IgA ACPA could be used as a predictive factor for flare development in RA; and to look further into the changes in IgA ACPA levels in patients remaining in stable remission versus patients developing flare.Methods:We analysed serum of 111 patients from a multicentre randomized controlled trial ‘RETRO’. The study observational period was 12 months. Patients in the trial had to be in stable remission (DAS28-ESR<2.6) for a minimum of 6 months and were randomized into 3 different treatment arms: continuation of treatment, tapering by 50% or a gradual tapering until discontinuation [2]. IgA ACPA concentrations were measured with an enzyme-linked immunosorbent assay on CCP2-pre-coated plates.Results:60% of patients had IgG-ACPA. IgA ACPA levels were higher among the IgG-ACPA-positive patients (median 4.7 versus 2.24 µg/ml, p<0.0001). Baseline IgA1 and 2 ACPA levels were not different between patients who had a flare later on in the study period and those remaining in remission, showing no predictive value for flare development. However, the percentage of IgA2 in ACPA was correlating with the first registered DAS28 after flare (r=0.36, p=0.046). After the 12 months study period, IgA2 ACPA as well as IgA2% ACPA decreased significantly in patients who remained in stable remission by 17.5% (median, p<0.0001) and 13.6% (p=0.0006), respectively. By contrast, there was no significant change in IgA2 ACPA levels over time in patients who developed a flare. IgA1 ACPA levels remained stable over time. Disease management strategies did not seem to influence IgA ACPA levels in a specific way, as baseline levels were similar between patients on biological and conventional DMARDs and changes in levels after 12 months did not depend on the assignment to either of the study arms.Conclusion:Neither IgA1 nor IgA2 ACPA levels were predictive of flare development or associated with treatment strategies (though rituximab, JAK-inhibitors and abatacept were not amongst treatment options). However, in patients remaining in sustained remission after 1 year a decrease in IgA2 and IgA2% ACPA was observed and IgA2% ACPA was associated with DAS28 score registered after flare. This could be an indication towards ACPA of IgA2 isotype contributing to the severity of flare, alongside other factors, and its reduction being associated with a prolonged state of remission.References:[1]Steffen U, Koeleman CA, Sokolova MV, et al. IgA subclasses have different effector functions associated with distinct glycosylation profiles. Nat Commun 11, 120 (2020).[2]Haschka J, Englbrecht M, Hueber AJ, et al. Relapse rates in patients with rheumatoid arthritis in stable remission tapering or stopping antirheumatic therapy: interim results from the prospective randomised controlled RETRO study. Ann Rheum Dis. 75:45-51 (2016).Disclosure of Interests:None declared


2020 ◽  
Vol 70 (695) ◽  
pp. e399-e405
Author(s):  
Rachel Denholm ◽  
Richard Morris ◽  
Sarah Purdy ◽  
Rupert Payne

BackgroundLittle is known about the impact of hospitalisation on prescribing in UK clinical practice.AimTo investigate whether an emergency hospital admission drives increases in polypharmacy and potentially inappropriate prescriptions (PIPs).Design and settingA retrospective cohort analysis set in primary and secondary care in England.MethodChanges in number of prescriptions and PIPs following an emergency hospital admission in 2014 (at admission and 4 weeks post-discharge), and 6 months post-discharge were calculated among 37 761 adult patients. Regression models were used to investigate changes in prescribing following an admission.ResultsEmergency attendees surviving 6 months (N = 32 657) had a mean of 4.4 (standard deviation [SD] = 4.6) prescriptions before admission, and a mean of 4.7 (SD = 4.7; P<0.001) 4 weeks after discharge. Small increases (<0.5) in the number of prescriptions at 4 weeks were observed across most hospital specialties, except for surgery (−0.02; SD = 0.65) and cardiology (2.1; SD = 2.6). The amount of PIPs increased after hospitalisation; 4.0% of patients had ≥1 PIP immediately before pre-admission, increasing to 8.0% 4 weeks post-discharge. Across hospital specialties, increases in the proportion of patients with a PIP ranged from 2.1% in obstetrics and gynaecology to 8.0% in cardiology. Patients were, on average, prescribed fewer medicines at 6 months compared with 4 weeks post-discharge (mean = 4.1; SD = 4.6; P<0.001). PIPs decreased to 5.4% (n = 1751) of patients.ConclusionPerceptions that hospitalisation is a consistent factor driving rises in polypharmacy are unfounded. Increases in prescribing post-hospitalisation reflect appropriate clinical response to acute illness, whereas decreases are more likely in patients who are multimorbid, reflecting a focus on deprescribing and medicines optimisation in these individuals. Increases in PIPs remain a concern.


Author(s):  
Hannah Moore ◽  
Tasmin Abdalla ◽  
Christopher Blyth ◽  
Ruth Gilbert ◽  
Pia Hardelid

ABSTRACTObjectiveAcute respiratory infections (ARI) including bronchiolitis, pneumonia and influenza are a major cause of hospital admissions in children worldwide. Linkage of administrative health datasets provides a platform to investigate temporal and seasonal trends in large populations over many years. We examined the similarities and differences in ARI admissions using linked datasets in Western Australia and England. ApproachThrough the availability of common data items in each jurisdiction, identical coding and data cleaning principles were applied to both datasets. Hospital admissions for ARI in children aged <5 years between 2000 and 2012 were identified using International Classification of Diseases diagnosis codes. Admission rates per 1000 child-years by age, gender and admission year were calculated in each jurisdiction. A total population birth cohort was available in Western Australia and the denominator was person time at risk whereas for England, all hospitalisations were used with the mid-year population as the denominator. ResultsThe overall incidence of ARI was 18.3/1000 child-years in Western Australia and 14.4/1000 in England. In both countries, the highest incidence of ARI was observed in infants (47.9/1000 child-years in Western Australia and 42.1/1000 child-years in England). Bronchiolitis was the most common primary diagnosis in infants in both countries, accounting for 79.7% of ARI admissions in Western Australia and 78.3% in England. The most common primary diagnosis in 1-4 year olds was unspecified lower respiratory tract infections in England (48.8% of ARI admissions in this age group) and pneumonia in Western Australia (43.9% of ARI admissions in 1-4-year-olds). The annual incidence rate for ARI hospitalisations declined in Western Australia from 2000 to 2006 and since remained steady. ARI admission rates increased in England throughout the study period. Admission rates across all age groups were 1.1-1.5 times higher in boys than girls in both countries. ConclusionThe availability of similar datasets in two economically similar countries in different hemispheres has afforded the opportunity to characterise and compare the epidemiology of paediatric respiratory infections over a 13 year period. Future analyses will allow us to assess differences in coding practices, seasonality and risk factors such as socio-economic deprivation and prematurity. Furthermore the availability of linked laboratory data for respiratory pathogens in each jurisdiction will allow for comparisons of pathogen-specific epidemiology and the impact of universal vaccination programs.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Issa Al Salmi ◽  
Yacoub Al Maimani ◽  
Fady Magdy ◽  
SUAD Hannawi

Abstract Background and Aims Interdialytic weight gain (IDWG) has been linked to various complications in hemodialysis (HD) patients, especially cardiovascular (CV) complications. We aimed to evaluate the effect of IDWG in HD patients on the rate of hospital admissions over a 12-month period, and the impact of high IDWG on the frequency of IDH. Method The study included 120 patients; who had been receiving HD for at least 3 months. The presence of various comorbidities has been recorded including. Laboratory data included; serum creatinine, serum albumin, and hemoglobin level. The estimated IDWG was calculated based on the average between pre- and post- dialysis weights that were recorded on 3 consecutive dialysis sessions. Results Among those who had IDWG ≥ 4%, 81% of these patients had at least one hospital admission due to volume overload or the need for extra HD session(s). On the other hand, only 19% of those having IDWG &lt; 4% had been admitted or got extra HD sessions (p&lt;0.001). Of those who were admitted (over 12 months) due to volume overload; 74.1 % had IDWG ≥ 4%, while 25.9% had IDWG &lt; 4% (p&lt; 0.001). Regarding IDH, 87% of patients having IDWG ≥ 4% had at least one episode of IDH/week. On the other hand, only 22.5% of those with IDWG &lt; 4% had one episode of IDH/week (p&lt;0.001). When analyzing those who had at least one IDH episode/week; 72.9% of them had IDWG ≥ 4%, while only 27.1% had IDWG &lt; 4% (p&lt;0.001). Conclusion In HD patients, the frequency of hospital admission due to volume overload and the need for extra HD sessions is strongly related to the amount of IDWG (&gt; 4% in our patients), the same stands for the frequency of IDH. Thus, a control of IDWG in HD patient is of great importance, keeping in mind the importance the nutrition status of HD patients that may also impact IDWG.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1415.1-1415
Author(s):  
F. Ingegnoli ◽  
T. Ubiali ◽  
T. Schioppo ◽  
V. Longo ◽  
S. Iodice ◽  
...  

Background:Air pollution is believed to cause oxidative stress and systemic inflammation, that could trigger autoimmunity in rheumatoid arthritis (RA). Several epidemiological studies investigated the possible role of air pollution in the outbreak of RA with controversial results. As far as we know, studies on the effects on disease activity of short-term exposure have not been published.Objectives:To evaluate the impact of short-term exposure to air pollutants (daily mean PM10, PM2.5, NO2and O3) on disease activity in patients with RA.Methods:Consecutive patients with RA (ACR/EULAR Criteria 2010) resident in Lombardy (Italy) were enrolled. In each patient Disease Activity Score on 28 joints (DAS28), Simple Disease Activity Index (SDAI) were assessed. Daily PM10, PM2.5, NO2and O3concentrations, estimated by Regional Environmental Protection Agency at municipality resolution, were used to assign short-term exposure from day of visit back to 14 days. Multivariable linear regression models were performed to identify the day of the pollutants independently associated with disease activity indices, adjusting for the variables significant at the univariate analysis. β coefficients were reported for 1 μg/m3increments of pollutants’ concentrations.Results:422 RA patients were enrolled in the study between January and June 2018: 81.5% females, mean age 58.2±13.3 years, mean disease duration 16.1±11.5 years, 27.3% current smokers, 59.5% RF positivity, 54.5% ACPA positivity. Sparse punctual statistically significant negative associations emerged at the multivariate analysis between PM10, PM2.5, NO2and the outcomes, although with very low estimates, whereas positive associations resulted for O3.Afterwards patients were stratified in 3 subgroups according to their ongoing treatment (no therapy, n=25, conventional synthetic Disease Modifying anti-Rheumatic Drugs -DMARDs-, n=108 and biological or targeted synthetic DMARDs, n=289). A statistical significance was found by analysing the influence of therapy on the interaction between PM2.5and DAS28 (Figure below): a positive trend between PM2.5and DAS28 appeared in the first two groups (no therapy, 0.013±0.007, p=0.06 and csDMARDs, 0.006±0.004, p=0.17), whereas a statistically significant inverse association was seen in the b/tsDMARDs group (-0.005±0.002, p=0.01). Therapy interaction was particularly evident in several days before the visit also for O3.Conclusion:The changes of the outcome measures related to the increase of the pollutants’ levels did not reach the minimal clinically important difference, therefore air pollution seems barely relevant on disease activity once the loss of tolerance is established in RA. O3and PM/NO2always exhibit an opposite performance having inversely proportional atmospheric concentrations, whereas the biological role of this substance is still matter of debate and will need further understanding. Therapy seems to be able to interact with the relation between air pollutants and the parameters considered.Disclosure of Interests:Francesca Ingegnoli: None declared, Tania Ubiali: None declared, Tommaso Schioppo: None declared, Valentina Longo: None declared, Simona Iodice: None declared, Ennio Giulio Favalli Consultant of: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Speakers bureau: Consultant and/or speaker for BMS, Eli-Lilly, MSD, UCB, Pfizer, Sanofi-Genzyme, Novartis, and Abbvie, Orazio De Lucia: None declared, Antonella Murgo: None declared, Valentina Bollati: None declared, Roberto Caporali Consultant of: AbbVie; Gilead Sciences, Inc.; Lilly; Merck Sharp & Dohme; Celgene; Bristol-Myers Squibb; Pfizer; UCB, Speakers bureau: Abbvie; Bristol-Myers Squibb; Celgene; Lilly; Gilead Sciences, Inc; MSD; Pfizer; Roche; UCB


2018 ◽  
Vol 38 (6) ◽  
pp. 719-729 ◽  
Author(s):  
Eva-Maria Didden ◽  
Yann Ruffieux ◽  
Noemi Hummel ◽  
Orestis Efthimiou ◽  
Stephan Reichenbach ◽  
...  

Background. Decision makers often need to assess the real-world effectiveness of new drugs prelaunch, when phase II/III randomized controlled trials (RCTs) but no other data are available. Objective. To develop a method to predict drug effectiveness prelaunch and to apply it in a case study in rheumatoid arthritis (RA). Methods. The approach 1) identifies a market-approved treatment ( S) currently used in a target population similar to that of the new drug ( N); 2) quantifies the impact of treatment, prognostic factors, and effect modifiers on clinical outcome; 3) determines the characteristics of patients likely to receive N in routine care; and 4) predicts treatment outcome in simulated patients with these characteristics. Sources of evidence include expert opinion, RCTs, and observational studies. The framework relies on generalized linear models. Results. The case study assessed the effectiveness of tocilizumab (TCZ), a biologic disease-modifying antirheumatic drug (DMARD), combined with conventional DMARDs, compared to conventional DMARDs alone. Rituximab (RTX) combined with conventional DMARDs was identified as treatment S. Individual participant data from 2 RCTs and 2 national registries were analyzed. The model predicted the 6-month changes in the Disease Activity Score 28 (DAS28) accurately: the mean change was -2.101 (standard deviation [SD] = 1.494) in the simulated patients receiving TCZ and conventional DMARDs compared to -1.873 (SD = 1.220) in retrospectively assessed observational data. It was -0.792 (SD = 1.499) in registry patients treated with conventional DMARDs. Conclusion. The approach performed well in the RA case study, but further work is required to better define its strengths and limitations.


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