O FitzGerald

St Vincent's University Hospital, Dublin, Leinster, Ireland

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Publications (214)1175.63 Total impact

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    ABSTRACT: Guidelines for the prevention of glucocorticoid (GC) induced osteoporosis (GIOP) were implemented in a level 5 Irish Hospital with cross sectional audit of inpatient prescribing undertaken before and after. Prior to guideline implementation, elemental calcium (Ca) with Vitamin D (VitD) was prescribed for 11/66 (17%) of patients on GCs with 2/66 (3%) also receiving bisphosphonate (BP) therapy. Subsequent to guideline implementation, Ca with VitD was prescribed for 19/55 (35%) of patients on GCs with 11/55 (20%) also receiving BP therapy, representing a 2 and 6 fold respective increase. Internal promotion of guidelines is an effective strategy for healthcare improvement but needs refinement with or without repetition to achieve better patient outcomes.
    Irish medical journal 09/2015; 108(7):216-7. · 0.51 Impact Factor

  • Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):83.1-83. DOI:10.1136/annrheumdis-2015-eular.4735 · 10.38 Impact Factor
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    ABSTRACT: Objective Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of certolizumab pegol (CZP) over 24 weeks in patients with psoriatic arthritis (PsA), including patients with prior antitumour necrosis factor (TNF) therapy. We report efficacy and safety data from a 96-week data cut of RAPID-PsA. Methods RAPID-PsA was placebo-controlled to week 24, dose-blind to week 48 and open-label to week 216. We present efficacy data including American College of Rheumatology (ACR)/Psoriasis Area and Severity Index (PASI) responses, HAQ-DI, pain, minimal disease activity (MDA), modified total Sharp score (mTSS) and ACR responses in patients with/without prior anti-TNF exposure, in addition to safety data. Results Of 409 patients randomised, 273 received CZP from week 0. 54 (19.8%) CZP patients had prior anti-TNF exposure. Of patients randomised to CZP, 91% completed week 24, 87% week 48 and 80% week 96. ACR responses were maintained to week 96: 60% of patients achieved ACR20 at week 24, and 64% at week 96. Improvements were observed with both CZP dose regimens. ACR20 responses were similar in patients with (week 24: 59%; week 96: 63%) and without (week 24: 60%; week 96: 64%) prior anti-TNF exposure. Placebo patients switching to CZP displayed rapid clinical improvements, maintained to week 96. In patients with ≥3% baseline skin involvement (60.8% week 0 CZP patients), PASI responses were maintained to week 96. No progression of structural damage was observed over the 96-week period. In the Safety Set (n=393), adverse events occurred in 345 patients (87.8%) and serious adverse events in 67 (17.0%), including 6 fatal events. Conclusions CZP efficacy was maintained to week 96 with both dose regimens and in patients with/without prior anti-TNF exposure. The safety profile was in line with that previously reported from RAPID-PsA, with no new safety signals observed with increased exposure. Trial registration number NCT01087788.
    06/2015; 1(1):e000119. DOI:10.1136/rmdopen-2015-000119
  • M. Elmamoun · M. Haroon · P. Gallagher · O. FitzGerald ·

    Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):1173.2-1174. DOI:10.1136/annrheumdis-2015-eular.5098 · 10.38 Impact Factor
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    ABSTRACT: Background In 2013, the first patients were entered in to ASRI – the Ankylosing Spondylitis Registry of Ireland. The primary objectives of ASRI are to provide basic descriptive epidemiological data on the Ankylosing Spondylitis (AS) population in Ireland, and to establish a registry for potential future studies of genetics, aetiology and therapeutics. Objectives In this current study we were interested in exploring the issue of obesity in an AS cohort, and the effect this has on disease activity and functional impairment. Methods A standardised detailed clinical assessment of patients is performed on each patient and entered in a web-based database. Specific measures of disease activity (BASDAI), function (BASFI and HAQ), and quality of life (ASQoL) were obtained. Body Mass Index (BMI) was calculated. The cohort was divided in to those of normal weight (BMI <25), and those that were overweight or obese (BMI >25). The 2 cohorts were compared using a number of different clinical variable using standard t-test. Results As of Dec 2014, 267 patients have been entered in the database (212 males, 55 females). The average age of the cohort is 47.8 years. The average disease duration is 21.7 years. The average delay in diagnosis is 8.2 years. As regards extra-spinal manifestations, 15.8% have Psoriasis, 40.4% have uveitis, 13% have Crohns/IBD. Of the 267 patients, 183 were overweight or obese (68.5%). There is a significant difference in BASFI scores between normal weight AS patients versus those that are overweight/obese. There is also a trend towards higher BASDAI, HAQ and ASQoL in those that are overweight/obese also. See Table below. There were a higher percentage of patients with Hypertension (30% versus 13%), Hyperlipidaemia (15% versus 7%) and Diabetes (7% versus 4%) in those that were overweight/obese. The rate of current or past smokers was very similar between the 2 cohorts, 57% (normal weight cohort) and 60% (overweight/obese cohort). Conclusions The majority of AS patients in our cohort were overweight or obese. These patients have a greater burden of symptoms and more functional impairment. They also have a higher percentage of other cardiovascular risk factors. As our awareness of the increased risk of cardiovascular disease in AS patients improves this is important information in on going management. Acknowledgements I would like to acknowledge Abbvie and Pfizer for the unrestricted support of ASRI. I would also like to acknowledge all the effort from the rheumatology community in Ireland for their hard work, enthusiasm and support of ASRI. Disclosure of Interest None declared
    Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):500.3-501. DOI:10.1136/annrheumdis-2015-eular.5580 · 10.38 Impact Factor
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    O. FitzGerald · R. Fleischmann · B. Hoepken · L. Peterson · D. Gladman ·
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    ABSTRACT: Background Previous reports of RAPID-PsA (NCT01087788) have demonstrated the clinical efficacy of certolizumab pegol (CZP) in patients (pts) with psoriatic arthritis (PsA) over 96 weeks (wks), but have not yet investigated the long-term improvements in extra-articular manifestations (EAMs) of PsA.1 Objectives To report the efficacy of CZP for the treatment of EAMs in PsA including nail psoriasis, enthesitis, dactylitis, and psoriasis, over 96 wks of the RAPID-PsA trial. Methods RAPID-PsA1 was double-blind and placebo (PBO)-controlled to Wk24, dose-blind to Wk48 and open-label to Wk216. Pts had active PsA and had failed ≥1 DMARD. Pts were randomized 1:1:1 to either PBO or CZP 400mg loading dose at Wks 0, 2, 4 followed by 200mg Q2W or 400mg Q4W. We present efficacy data for all pts originally randomized to CZP. The primary clinical endpoint was Wk12 ACR20 response.2 EAMs were assessed in pts with baseline (BL) involvement and included nail psoriasis (modified nail psoriasis severity index [mNAPSI], BL involvement = BL mNAPSI >0; for some pts the nail analyzed was changed once or more to Wk96), enthesitis (Leeds enthesitis index [LEI], BL involvement = BL LEI >0), dactylitis (Leeds dactylitis index [LDI], BL involvement = at least 1 digit affected and with a difference in circumference ≥10%) and psoriasis (body surface area affected [BSA], BL involvement = BL BSA ≥3%). We also present data for pts with total resolution of each EAM, ie. the percentage of pts with BL involvement achieving complete clearance (a score of 0 for mNAPSI, LEI or LDI, or 0% BSA). Data shown are observed values. Results Of 409 pts randomized, 273 received CZP from Wk0. At BL, 197 of these pts had nail psoriasis, 172 enthesitis, 73 dactylitis and 166 psoriasis. Rapid reductions in scores were seen in all EAMs assessed and were maintained to Wk96 of the study. Improvements were observed in nail psoriasis, enthesitis, dactylitis and psoriasis, for pts with BL involvement (Table). These improvements were observed in pts treated with either CZP dose regimen. A large proportion of pts with BL EAM involvement went on to achieve total resolution. For pts with nail psoriasis at BL, 38.5% had achieved total resolution at Wk24 and 65.2% at Wk96. Similar results were seen for pts with enthesitis, dactylitis, or psoriasis at BL (pts with enthesitis at BL achieving total resolution: 65.2% at Wk24 and 71.0% at Wk96; pts with dactylitis at BL achieving total resolution: 73.8% at Wk24 and 89.5% at Wk96; pts with psoriasis at BL achieving total resolution: 26.8% at Wk24 and 48.5% at Wk96). Conclusions Improvements in EAMs of PsA were observed following CZP treatment and were maintained to Wk96 of RAPID-PsA. These improvements were seen in all EAMs measured, including nail psoriasis, enthesitis, dactylitis and psoriasis. Similar improvements were observed with both CZP dose regimens. References Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance, which was funded by UCB Pharma. Disclosure of Interest O. FitzGerald Grant/research support from: Abbvie, Roche, MSD, BMS, Speakers bureau: Janssen, Pfizer, Abbvie, UCB Pharma, Cellgene, R. Fleischmann: None declared, B. Hoepken Employee of: UCB Pharma, L. Peterson Employee of: UCB Pharma, D. Gladman Consultant for: Abbott, Bristol Myers Squibb, Celgene, Johnson & Johnson, MSD, Novartis, Pfizer, UCB Pharma
    Annals of the Rheumatic Diseases 06/2015; 74(Suppl 2):349.1-349. DOI:10.1136/annrheumdis-2015-eular.1847 · 10.38 Impact Factor
  • A. Szentpetery · M. Haroon · P. Gallagher · E. Heffernan · O. FitzGerald ·
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    ABSTRACT: Background and objectives Despite RA and PsA share similar pathophysiological concepts, there are profound differences in the anatomical localisation of inflammatory lesions and in periarticular bone structure. Digital X-ray radiogrammetry (DXR) is a sensitive method for quantifying changes in periarticular bone mineral density (DXR-BMD) in the early phase of the disease. The aim of this study was to compare changes in hand BMD as measured by DXR in early, treatment-naïve RA to PsA patients prior to and 3, 12 months after introducing an anti-rheumatic drug. Methods Recent-onset (<12 months), active, treatment naïve PsA and RA patients were selected. Hand BMD was measured by DXR based on digitised hand radiographs (Sectra, Sweden) at baseline, 3 and 12 months. Mean DXR-BMD (mg/cm2) values of both hands and changes in DXR-BMD (mg/cm2/month) were compared between the two groups. Changes in hand BMD were further analysed by dividing PsA and RA into 3 subgroups based on cut-offs for the categories normal, elevated BMD loss (>-0.25 mg/cm2/month) and highly elevated BMD loss (>-2.5 mg/cm2/month). Results 64 patients (32 RA, 32 PsA) were included with median age 43 years. 95% of the patients were started on a DMARD at baseline and stayed on it at 12 months; 12.5% and 34.5% received TNFi in combination with a DMARD, respectively. 69% of RA and 68% of PsA patients were EULAR responders at 3 months, and 80% and 82% at 12 months, respectively. Mean hand DXR-BMD was lower in both diseases at 3 months compared to baseline. In RA DXR-BMD decreased further and was lower at 1 year compared to baseline (p = 0.004) and to 3 months (p = 0.002). In contrast mean DXR-BMD increased from 3 to 12 months in PsA (p = 0.07). Hand BMD was higher in PsA than in RA throughout the study. Patients started on a TNFi in combination with a DMARD had higher hand DXR-BMD at 3 and 12 months comparing with those who started on a DMARD monotherapy (p = 0.015 and p = 0.021, respectively). Among all patients with elevated BMD loss, change in DXR-BMD was less marked in the PsA group compared to RA from baseline to 3 (p = 0.018) and from 3 to 12 months (p = 0.011). Highly elevated bone loss was present only in the RA cohort at 1 year. Conclusions To our knowledge, this is the first prospective study comparing hand BMD changes in RA to PsA using DXR. Despite intervention of appropriate anti-rheumatic drug and improvement in disease activity measures, we found hand bone loss in RA, but bone gain in PsA after 12 months. Our observations support the hypothesis of different pathomechanisms being involved in hand bone remodelling in PsA.
    Annals of the Rheumatic Diseases 02/2015; 74(Suppl 1):A41-A41. DOI:10.1136/annrheumdis-2015-207259.94 · 10.38 Impact Factor
  • M O'rourke · M Haroon · P Ramasamy · O Fitzgerald · C Murphy ·
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    ABSTRACT: Purpose The association between anterior uveitis (AU) and spondyloarthritis (SpA) is well established. However, no algorithm exists to advise the ophthalmologist of which patients with AU should be referred to the rheumatolgist as a suspect SpA. Early diagnosis in SpA is key as disease severity and morbidity is related to disease duration. This study firstly establishes the incidence of SpA in an Irish cohort of patients attending eye casualty with previously unknown SpA. It also establishes a highly effective predictive algorithm to advise which patients should be referred to a rheumatologist as potential SpA.Methods 104 consecutive patients with non-infectious AU were recruited prospectively and subsequently screened by a rheumatologist for SpA. The most statically significant features were used to generate a predictive algorithm which was subsequently validated in a further cohort of 80 patients.Results The incidence of SpA is 41.5% with average duration of backache 9.36 years. Multiple regression analysis with detailed step wise post-hoc analysis identified that patients <45 years, with backache >3 months should have HLA-B27 checked. If positive, a referral is appropriate. If negative, a history of psoriasis should be ascertained and if present, the patient should be referred. This algorithm has sensitivity of 95% and specificity of 98%. Validation of this algorithm in a second cohort had comparable sensitivity and specificity.Conclusion The ophthalmologist has a necessary role in identifying SpA. Close collaboration between ophthalmologists and rheumatologists utilizing our algorithm will result in earlier treatment intervention to improve disease outcome.
    Acta ophthalmologica 09/2014; 92(s253). DOI:10.1111/j.1755-3768.2014.3445.x · 2.84 Impact Factor
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    ABSTRACT: Background Abatacept, a soluble, fully human fusion protein which selectively inhibits T-cell activation via competitive binding to CD80/CD86, decreases serum levels of cytokines and inflammatory proteins implicated in the pathogenesis of psoriatic arthritis (PsA). It has been proposed that 10 mg/kg of abatacept, the approved dose for rheumatoid arthritis may be an effective treatment choice for PsA. [1] Objectives (1) To study both skin and joint-related clinical outcomes prior to and 6 months after introducing abatacept treatment in PsA; (2) To investigate MRI changes of an inflamed knee joint over time in PsA patients on abatacept. Methods 15 biological treatment-naïve PsA patients fulfilling the CASPAR criteria with active disease for ≥3 months (≥3 swollen and ≥3 tender joints) with clinical synovitis of a knee and the presence of a psoriatic skin lesion were enrolled in the study. Patients were randomised to receive abatacept 3mg/kg or placebo infusion on day 1, 15 and 29; thereafter abatacept 10mg/kg was administered to all patients every 28 days for 5 months. A stable dose of methotrexate (7.5-25 mgs/week) for >3 months prior to randomization was the only concomitant DMARD permitted. Gad-enhanced MRI of the same involved knee was performed at baseline, 2 and 6 months and scored using the PsAMRIS method by one consultant radiologist. For the semi-quantitative method each knee was divided into 4 anatomical regions; medial (MED) and lateral (LAT) parapateller recesses, intercondylar notch (ICN) and suprapatellar pouch (SPP). A synovitis score ranging from 0 to 3 was assigned to each region and then added to give a total MR synovitis score (MRS) ranging from 0 to 12. Results At the time of the analysis, the study is still blinded and so the results discussed are the overall results from 14 of the 15 patients. Patients (8 female/6 male) mean age was 44.6 (±15.2) years. Four patients were on methotrexate with the remainder not receiving any DMARDs during the study. At baseline patients' mean DAS28-ESR was 4.9 (±1) and DAS28-CRP 4.8 (±0.8). Median PASI, HAQ, PsAQol and DLQI were 3.6 (0-9.6), 1 (0-2.125), 10.5 (1-17) and 2.5 (0-27) respectively. Mean synovitis scores at MED, LAT, ICN and SPP regions were 2.07 (±0.9), 2.21 (±0.9), 1.4 (±0.8) and 1.85 (±1) respectively at baseline; mean MRS was 7.6 (±3.4). As per EULAR criteria 87.5% of the patients responded to the treatment at 6 months; 75% judged a good responder. 68 tender and 66 swollen joint counts, duration of morning stiffness, global health score, DAS28-ESR, DAS28-CRP, HAQ and PsAQol reduced significantly at 6 months compared to baseline. While there was no significant difference compared to baseline in the 4 anatomical region scores, the median MRS decreased over the study period and was significantly lower at 6 months compared to baseline (p=0.016). Conclusions These interim results show that 6 months of abatacept treatment reduced synovitis scores as assessed by MRI. Our results mirror the clinical improvements observed and support published data suggesting that 10 mg/kg of abatacept is a potent treatment option in PsA. References Acknowledgements This study received drug and financial support from Bristol Myers Squibb. Disclosure of Interest A. Szentpetery: None declared, E. Heffernan: None declared, M. Haroon: None declared, P. Gallagher: None declared, A.-M. Baker: None declared, M. Cooney: None declared, O. FitzGerald Grant/research support: Pfizer, Abbott, BMS, MSD, Roche, UCB, Consultant for: Pfizer, Abbott, BMS, MSD, Janssen, Roche, Speakers bureau: Pfizer, Abbott, Janssen, Roche, UCB DOI 10.1136/annrheumdis-2014-eular.5531
    Annals of the Rheumatic Diseases 06/2014; 73(Suppl 2):731-731. DOI:10.1136/annrheumdis-2014-eular.5531 · 10.38 Impact Factor
  • M. Haroon · J. T. Giles · R. Winchester · O. FitzGerald ·
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    ABSTRACT: Background A rigorously ascertained psoriatic arthritis (PsA) cohort demonstrated considerable genetic heterogeneity and provided preliminary evidence that MHC genes determine quantitative traits within the PsA phenotype with different patterns of MHC effect. (Arth & Rheum 2012. 64: 1134). Objectives To investigate any potential association of clinical phenotypes with already well characterised and quantified genotypes of PsA patients belonging to a genetically relatively homogeneous population Methods A consecutive cohort of 283 PsA patients underwent detailed skin and rheumatologic assessments. We chose four traits to analyze - sacroiliitis, enthesitis, joint deformity and dactylitis. To examine their genotypic interaction, we assigned a score to each patient’s allele and haplotype. +1 if an allele or haplotype was associated with a high risk for the trait, and -1 if it conferred a low risk in univariate analysis. Alleles or haplotypes not significantly associated with a trait were assigned “0”, and the score summed assuming an additive risk model. Results A total of 283 PsA patients [mean age 55±12 years; 47% male; mean PsA duration=19±9 years; 25% with sacroiliitis; 44.5% with radiographic erosions; 34% with enthesitis; 53% with dactylitis, 60% of this PsA cohort requiring TNFi therapy] were studied. The figure shows the frequency of each trait as a function of the risk score for the alleles and haplotypes associated with high or low risk and the average change in the odds of having each trait per 1 unit increase in the genotype risk score, e.g. the OR of developing enthesitis with an alleles/haplotypes genotype score of +2 to +4 was 13.9, p<0.001. Conclusions HLA genotype importantly influences the clinical phenotype of psoriatic arthritis; and these phenotypes are likely the result of cis and trans interactions of multiple individual alleles. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A969-A969. DOI:10.1136/annrheumdis-2013-eular.2908 · 10.38 Impact Factor
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    ABSTRACT: Background There is a growing interest in bone and cartilage biomarkers that could be used predicting and assessing changes in structural damage in inflammatory arthritis. Disease-related bone loss assessed by dual-energy X-ray absorptiometry (DXA) is a well known feature in RA and PsA, however data on bone loss during the first year of treatment in early disease are limited. Objectives (1) To study changes in serum levels of bone biomarkers and bone mineral density (BMD) measurements in early PsA and RA prior to and 12 months after introducing an anti-rheumatic drug; (2) To explore associations between disease-related variables, serum bone biomarkers and BMD measurements; (3) To investigate if serum bone biomarkers prior to treatment predict systemic bone loss over 1 year in patients with PsA and RA. Methods Recent-onset (<12 months), active, treatment naive PsA and RA patients were recruited. We measured serum bone-specific alkaline phosphatase (bone ALP), a marker of bone formation, and C-terminal cross-linking telopeptide (CTX-I), a degradation marker of type-I collagen reflecting systemic bone resorption at baseline, 3 and 12 months by immunoassay. We assessed bone remodelling balance by calculating bone ALP/CTX-1 ratios. BMD measurements were obtained at left total hip and lumbar spine at baseline and 12 month by DXA. Clinical parameters were correlated with bone biomarkers and BMD measurements. Results 64 patients (32 PsA, 32 RA) were included with median age 43 years. 95% of the patients were commenced on a DMARD therapy at baseline and 11.7 % (12.5% RA; 10.7% PsA) were also started on a TNF inhibitor. At 12 months 94.8% of the patients were on a DMARD and 34.5% on TNF inhibitor (33.3 % RA; 35.7% PsA). Bone ALP levels did not change significantly in either cohort during the study. CTX-I levels decreased after 3 months of treatment in RA (p=0.013) and in the entire group (p=0.043) remaining lower at 12 months (p= 0.042; p= 0.012 respectively) compared to baseline. Bone ALP/ CTX-I ratio was higher (p=0.05) at 1 year compared to baseline in the entire group reflecting improvement in bone remodelling balance. Hip BMD decreased in both diseases, significantly in RA (p=0.021), whilst spine BMD decreased in RA (p=0.056) but increased in PsA (p=0.017). CTX-I levels were correlated inversely with hip BMD in PsA at both baseline and 12 months (r = -0.38, p= 0.04; r = -0.51, p= 0.007) and similarly in the entire group (r = -0.29, p= 0.03; r = -0.3, p= 0.02). Baseline CTX-I levels correlated with the change in hip BMD over 12 month in the whole group (r = 0.31, p= 0.03). Stepwise multiple logistic regression analysis revealed significant associations of baseline CTX-I levels with change in BMD of the hip over 12 months in PsA (OR 2.8, p=0.009) and in the entire cohort (OR 2.5, p=0.014) with the model also including bone ALP, ESR, CRP, DAS28 CRP and HAQ. Conclusions The improvement in bone remodelling balance seen in early PsA and RA patients is most likely due to decrease in bone resorption after 1 year of appropriate anti-rheumatic therapy. High baseline levels of serum CTX-I may predict systemic bone loss at the hip over 1 year in patients with PsA. Disclosure of Interest A. Szentpetery: None Declared, M. Kilbane: None Declared, M. O’Keane: None Declared, M. Haroon: None Declared, P. Gallagher: None Declared, S. van der Kamp: None Declared, M. McKenna: None Declared, O. FitzGerald Grant/research support from: Abbott, BMS, Pfizer, MSD, Consultant for: Abbott, UCB, Pfizer, Speakers bureau: Abbott, Pfizer, MSD
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A675-A675. DOI:10.1136/annrheumdis-2013-eular.1997 · 10.38 Impact Factor
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    ABSTRACT: Background Therapeutic targets have been defined for diseases like diabetes, hypertension or rheumatoid arthritis and adhering to them has improved outcomes. Such recommendations are unavailable for spondyloarthritis. Objectives To define the treatment target for spondyloarthritis including ankylosing spondylitis (AS) and psoriatic arthritis (PsA) and develop recommendations for achieving the target, including a treat-to-target management strategy. Methods Based on results of a systematic literature review (performed by MS) and expert opinion, a task force of expert physicians and patients developed recommendations, which were broadly discussed and voted upon in a Delphi-like process. Level of evidence, grade of recommendation and strength of recommendation were derived by respective means. Results The literature review did not reveal trials comparing a treat-to-target approach with another or no strategy, but provided indirect evidence that facilitated the development of recommendations. The task force agreed on 5 overarching principles and 11 recommendations. Based on the current perception and classification of spondyloarthritis (including PsA, axial SpA (AS and non-radiographic axial SpA), peripheral SpA), only the last 2 recommendations are separate for axial spondyloarthritis, peripheral spondyloarthritis and PsA, while principles and 9 of the recommendations form a common trunk for all types of spondyloarthritis. The main treatment target, which should be based on a shared decision with the patient, was defined as remission, with an alternative target being low disease activity. Means to assess disease activity are discussed. Regular follow-up examinations should safeguard the evolution of disease activity toward the targeted goal. Additional items relate to extraarticular and extramusculoskeletal aspects and other factors, such as comorbidity. While the level of evidence was low for all items, the mean strength of recommendation was 9-10 (10: maximum agreement) for all recommendations. A research agenda was formulated. Conclusions The recommendations shall inform patients, rheumatologists, dermatologists and other experts as well as other stakeholders about expert opinion that allows reaching optimal outcomes of spondyloarthritis including AS and PsA. Acknowledgements This work was supported by an unrestricted educational grant from Abbott. Disclosure of Interest J. Smolen Grant/research support from: Abbott, Consultant for: Abbott, J. Braun: None Declared, M. Dougados: None Declared, P. Emery: None Declared, O. FitzGerald: None Declared, P. Helliwell: None Declared, A. Kavanaugh: None Declared, T. Kvien: None Declared, R. Landewé: None Declared, T. Luger: None Declared, P. Mease: None Declared, I. Olivieri: None Declared, J. Reveille: None Declared, C. Ritchlin: None Declared, M. Rudwaleit: None Declared, M. Schoels: None Declared, J. Sieper: None Declared, M. de Wit: None Declared, D. van der Heijde: None Declared
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A88-A89. DOI:10.1136/annrheumdis-2013-eular.315 · 10.38 Impact Factor
  • L. C. Coates · O. Fitzgerald · D. Gladman · N. McHugh · P. Mease · V. Strand · P. S. Helliwell ·
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    ABSTRACT: Background Minimal disease activity (MDA) is defined by OMERACT as “that state of disease activity deemed a useful target of treatment by both the patient and physician, given current treatment possibilities and limitations” and criteria for MDA in psoriatic arthritis (PsA) have been developed using consensus opinion of international experts. Objectives The aim was to investigate if the criteria correlated well with the opinion of rheumatologists treating PsA and their patients and investigate how they compare with other composite outcome measures in development for PsA. Methods The study was an analysis of baseline visits for patients in the GRACE study, an international observational cohort recruited to develop new outcome measure in PsA. At baseline, data on all aspects of disease activity and patient reported outcomes were collected. The treating physician was asked “Do you think this patient is in an MDA state?” and the patient was asked “Do you think your disease is well controlled?” Patients were classified as MDA if they fulfilled 5 of 7 from: tender joint count≤1; swollen joint count≤1; psoriasis activity and severity index≤1 or body surface area≤3; patient pain visual analogue score (VAS)≤15; patient global disease activity VAS≤20; health assessment questionnaire≤0.5; tender entheseal points≤1. ROC analysis was used to test the MDA criteria using physician and patient opinion as the gold standard. Composite measure scores for those patient in MDA and those not were compared and tested using Mann-Whitney U statistics. Results In total, data on 503 patients were collected at baseline. Using the physician’s opinion as a gold standard, the MDA criteria performed well with an area under the curve of 0.82 (95% CI 0.79, 0.86, p<0.001). Using the proposed cut-off of 5 gave a sensitivity of 40.3% and a specificity of 97%. Using the patient’s opinion as a gold standard, the MDA criteria also performed well with an AUC of 0.80 (95% CI 0.76, 0.84, p<0.001). Again the specificity of the criteria was high (98%) but sensitivity was also lower (33%). Comparison was made with proposed composite outcome measures for PsA including the CPDAI, DAPSA, PASDAS and AMDF. Scores for those in MDA and those not showed good separation for all of these composite measures (p<0.001) with the highest z-statistics for the AMDF and CPDAI. Conclusions The MDA criteria for PsA correlate well with both physician and patient opinion in a large real-life observational cohort. The criteria had a high specificity for identifying patients with adequate disease control meaning that patients would not be undertreated using these criteria. The lower sensitivity identifies some patients who did not fulfil the criteria, but were still felt to have good disease control, identifying a tolerance by both physicians and patients for mild levels of disease activity in multiple domains of PsA. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 71(Suppl 3):575-575. DOI:10.1136/annrheumdis-2012-eular.3252 · 10.38 Impact Factor
  • M. Haroon · P. Gallagher · O. FitzGerald ·
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    ABSTRACT: Background Psoriatic arthritis (PsA) is characterised by involvement of both the appendicular and axial skeleton. The reported prevalence of sacroiliitis (SI) in patients with PsA is quite variable and ranges from 30% to 78%. Little is known about the clinical predictors of sacroiliitis, especially regarding underlying patient’s characteristics, life style, correlation with skin disease and the severity of psoriatic disease. Objectives The objectives of our study were: 1) To investigate the prevalence of SI in an ethnically homogenous consecutive cohort of established PsA, 2) to identify clinical predictors of SI in patients with PsA, 3) to describe different patterns of SI and their associations, if any, with clinical characteristics. Methods A consecutive cohort of 283 PsA patients attending rheumatology clinics at St Vincent’s University Hospital, Dublin was included. Following informed consent, patients underwent a detailed skin and rheumatologic assessment including disease activity measures [PASI, Body Surface Area (BSA) for Psoriasis (Ps); DAS 28 CRP], CRP and ESR, HAQ, Dermatology Life Quality Index (DLQI), Bristol Rheumatoid Arthritis Fatigue Numeric Rating Scale (BRAF-NRS), EuroQuol questionnaire (EQ5D), and radiographs were taken for involved joints along with hands, feet and sacroiliac joints. Other risk factors studied were gender, smoking habits, BMI, family history of Ps & PsA, different types of Ps, psoriatic nail disease, duration of Ps and PsA, enthesitis, dactylitis, prior DMARDs usage, psoriatic disease requiring TNFi, erosions, arthritis mutilans, educational attainment, insulin resistance, metabolic syndrome. In addition, an extensive medical record review was performed to obtain information regarding their previous psoriatic disease features. We defined the criteria for identifying SI if ≥ grade 2 radiographic changes were present (unilateral or bilateral). Asymmetrical SI was labelled when grades were different between 2 SI joints, and unilateral SI was labelled when the opposite SI joint was completely uninvolved. Results A total of 283 PsA patients [mean age 55±12 years; 52% female; mean PsA duration=19±9 years] were studied. Twenty five percent (71/283) of the cohort had radiographic SI; all either had present or past history of backache. Mean age of patients with SI was 51.6±11 years, and 53.5% were male. SI was asymmetrical in 77.5% (n=51), but SI was bilateral in 62% (34 out of 51) of these patients. The asymmetrical SI group were noted to be more female (p=0.050) with less nail disease (p=0.02), and less enthesitis (p=0.002). On univariate analysis, SI was noted to have significant association with younger age (p=0.01), longer duration of PsA (p=0.001), younger age of Ps and PsA onset (p=<0.001 each), higher PASI score (p=0.01), peripheral joint erosions (p=0.008), and maximum CRP and ESR achieved during the disease course (p=0.009, 0.03, respectively). On backward step-wise multiple regression analysis, model predicted significant association of erosions (OR 1.9, p=0.02), PsA age of onset (OR 0.94, p=<0.001), and PASI max (OR 1.06, p=0.02) with SI. Conclusions Twenty five percent of PsA patients developed SI on long-term follow up, and SI was asymmetrical in more than two third of these cases. Erosive peripheral arthritis, severe skin Ps, and earlier onset of PsA were positively associated with developing SI. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A683-A683. DOI:10.1136/annrheumdis-2013-eular.2019 · 10.38 Impact Factor
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    ABSTRACT: Background Despite recommendations to use full joint counts to assess patients with PsA, reduced joint counts designed for RA are often used for reporting outcomes in PsA registry studies and are used in clinical practice to assess patients with PsA. Analysis of RCTs suggested that 28 joint counts were responsive in PsA but this analysis was based on polyarticular patients enrolled into drug trials. Objectives The aim of this analysis was to investigate full and reduced joint counts in patients with oligoarticular PsA. Methods The study was an analysis of baseline visits for patients in the GRACE study, an international observational cohort recruited to develop new outcome measure in PsA. Oligoarthritis was defined as less than 5 tender and swollen joints. At baseline, full 76/78 tender and swollen joint counts were assessed. Reduced joint counts used for RA including the 28 and 44 joint count were analysed for comparison. In addition, new proposed shortened joint counts for PsA were tested to investigate their possible future use: PsA-44 (elbows, wrists, MCPs, PIPs, DIPs, knees and MTPs) and PsA-56 (as before plus ankles and PIP toes). ROC analysis was used to see how well different joint counts predicted treatment change for high disease activity. The proportion of patients with active disease missed by reduced joint counts was also analysed. Results In the cohort of 503 patients, 270 were classified as oligoarthritis. ROC analysis revealed that tender joint counts did not predict treatment change for high disease activity even when using a full 78 joint count (AUC 0.54, p=0.32). A 76 SJC did predict treatment change (AUC 0.61, p=0.008) as did a 66 SJC and the SJC PsA44 and PsA56 (p<0.04). Neither of the RA reduced joint counts showed a significant relationship with treatment change. Of the 270 patients, 164 patients did not have any tender joints identified on a 28 joint count. However, of these 164, 38 did have 1 or more tender joints that had been missed (23%), leaving 126 patients with no tender joints. The PsA-44 and PsA-56 missed tender joints in 18 and 7 patients respectively. When considering swollen joints, 256 patients did not have any swollen joints identified on a 28 joint count but 48 of these (19%) did have swollen joints elsewhere. The PsA-44 and PsA-56 missed swollen joints in 26 and 7 patients respectively. Conclusions Patients with oligoarticular PsA cannot be assessed using joint counts borrowed from RA. Ideally full joint counts should be performed to assess PsA patients with the 66/68 joint count being the preferred measure due to difficulties distinguishing between the PIPs and DIPs of the toes. Reduced joint counts designed specifically for PsA do show correlation with treatment change but can still underestimate disease activity. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 71(Suppl 3):570-570. DOI:10.1136/annrheumdis-2012-eular.3238 · 10.38 Impact Factor
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    ABSTRACT: Background During Phase 1 of the 52 wk open-label PRIZE study treatment of patients (pts) with early (mean 6 mos.) moderate-severe rheumatoid arthritis (RA), who were methotrexate (MTX)/biologic naïve, with 50 mg etanercept (ETN) + 10-25 mg MTX yielded a 70% remission rate with no significant radiographic progression.1 Pts achieving remission in Phase I were randomized to a double-blind 39-wk period of reduced (25mg) ETN + MTX or withdrawn (MTX alone or placebo, PBO) therapy (PRIZE Phase 2). Objectives To assess sustained remission (DAS28 and ACR/EULAR Boolean [AEB]), other clinical, radiographic, and safety outcomes in pts subsequently treated with reduced dose ETN or PBO after remission induction during PRIZE Phase 1. Methods Pts achieving DAS28 remission by wk 52 (≤3.2 at wk 39, <2.6 at wk 52) in Phase 1 (n=193) were randomized 1:1:1 to ETN25/MTX: MTX + PBO injection: PBO capsules + PBO injection at wk 52. Pts with DAS28>3.2 (> low disease activity, LDA) received corticosteroid boosts at wks 56 or 64; pts not achieving LDA at the next visit withdrew. Remission and other standard clinical outcomes were assessed. Odds ratios and significance were determined by logistic regression models. Results ETN/MTX resulted in a significantly higher proportion of pts in sustained and AEB remission than MTX alone or PBO. More ETN/MTX treated pts achieved DAS28 LDA than PBO. Over Phase 2 radiographic progression (mTSS >0.5) occurred in <12% of pts, with no significant difference between treatment arms; at Phase 1 baseline the mTSS scores were 8.06, 8.46 and 7.59 for ETN25/MTX, MTX and PBO, with changes of 0.44, -0.5 and 1.41 by last observations in Phase 2 (LOCF), indicating no clinically relevant radiographic progression in any of these treatment groups ETN/MTX treatment resulted in more pts achieving ACR50 and 70 than PBO. There were no unexpected safety findings. Conclusions Of the moderate-severe early RA pts achieving DAS28 remission during a 52 wk induction (50 mg ETN/MTX in PRIZE Phase 1), 63.5% maintained remission (DAS28<2.6 at wk 76 & 91 visits) with ETN25/MTX, 38.5% with MTX and 23% with PBO over 39 subsequent wks. There was no significant radiographic progression in any treatment group. There were no unexpected safety findings. References Acknowledgements The PRIZE study was funded by Pfizer Inc. Disclosure of Interest P. Emery Consultant for: Abbott, Bristol-Myers Squibb, Merck, Novartis, Pfizer Inc, Roche-Chugai, UCB Pharma Ltd, M. Hammoudeh Consultant for: Pfizer Inc, Roche, Abbott Laboratories, O. FitzGerald Consultant for: Bristol-Myers Squibb, Roche, Abbott Laboratories, Pfizer Inc, UCB Pharma Ltd, B. Combe Consultant for: Bristol-Myers Squibb, Merck, Pfizer Inc, Roche-Chugai, UCB Pharma Ltd, E. Martin Mola Consultant for: Pfizer Inc, Roche, Celgene Ltd, UCB Pharma Ltd, Speakers bureau: Pfizer Inc, Roche, UCB Pharma Ltd, J. Bukowski Employee of: Pfizer Inc, R. Pedersen Employee of: Pfizer Inc, T. Williams Employee of: Pfizer Inc, S. Gaylord Employee of: Pfizer Inc, B. Vlahos: None Declared
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A399-A399. DOI:10.1136/annrheumdis-2013-eular.1216 · 10.38 Impact Factor
  • M. Haroon · P. Ramasamy · M. O'Rourke · C. Murphy · O. FitzGerald ·
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    ABSTRACT: Background Recent reports claim that the prevalence figures of mostly undiagnosed underlying Spondyloarthropathy (SpA) is more than 60% among patients presenting with acute anterior uveitis (AAU). To date, there are no formal guidelines or referral pathways for AAU patients developed or endorsed by any international or national societies. Therefore, in a condition where significant delay in diagnosis is common, and where AAU may frequently be the first interaction with medical care, an opportunity to identify SpA early is often missed leading to less than ideal care. Objectives The objectives of our study were: (1) to develop an assessment algorithm for referral from Ophthalmologists of appropriate AAU patients to Rheumatology that will aid the early diagnosis of the SpA; (2) to explore whether modifications of this novel algorithm might further improve sensitivity and specificity; and (3) to investigate the prevalence of undiagnosed SpA in patients presenting with AAU in a primary care ophthalmology setting. Methods All consecutive patients attending emergency department of local ophthalmology hospital with AAU, but who did not have a known diagnosis of SpA, were eligible to partake in this study. Patients with any other known cause of AAU were excluded. The HLA-B27 status was checked in all patients, and assessment and onward referral was made as per a test algorithm which combined clinical features and HLA-B27. Patients without risk factors for SpA and who were HLA-B27 negative remained part of the study as a control group; these patients also underwent detailed rheumatologic evaluation. Results 104 consecutive patients who attended the ophthalmology emergency department from September 2011 through to June 2012 were recruited. Mean age of the cohort was 42±15 years. and HLA- B27 was positive in 52.5%. According to the test algorithm, 71 out of 104 patients were referred to rheumatologists; 69 of them had complete rheumatologic assessment. After rheumatologic evaluation, 41.6% (n=42) of these patients were diagnosed with SpA as per ASAS classification criteria. Of these newly diagnosed patients, 64.3% had radiographic axial SpA. Non radiographic SpA patients were noted to have shorter duration of backache (p=0.03). Our test algorithm was noted to have: sensitivity 100%, specificity 53.5%, PPV 61% and NPV 100%. Further regression analysis revealed that algorithm version-1 could make the following improvements: sensitivity 95%, specificity 98%, PPV 97.5%, NPV 96.6%. Conclusions 41.5% of patients presenting with idiopathic AAU have undiagnosed SpA. A simple to apply algorithm is described with excellent sensitivity and specificity that is currently being validated in an additional cohort. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A661-A662. DOI:10.1136/annrheumdis-2013-eular.1962 · 10.38 Impact Factor
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    ABSTRACT: Background Spondyloarthropathies (SpA) are a family of disorders with common characteristics. This study compares baseline data and clinical outcomes 12 months post-TNFi therapy in patients with PsA plus spondylitis (PsAs), psoriatic arthritis without spondylitis (PsA) and ankylosing spondylitis (AS). Methods 77 SpA patients (n=23, PsAs; n=26, PsA; n=28, AS) were recruited, prior to TNFi therapy, and followed prospectively for 12 months. PsA was defined by the CASPAR criteria, PsAs plus inflammatory back pain and AS by the ASAS criteria. Demographic, radiographic, clinical and serological data were collected. Kruskal Wallis and Mann Whitney U tests were used to compare non parametric data between categories. Spearman’s Rho was used to test significance of correlations between baseline statistics and longitudinal outcomes. Results are presented as the mean and/or percentages. Statistical analysis was performed using SPSS 18. Results The PsAs group were significantly younger than the AS and the PsA group (43yrs<47yrs<53yrs; p=0.021). PsAs were more frequently male than AS and PsA (65% v 61% v 54%). 79% of AS patients were using NSAIDs compared to 52% of PsAs and 13% PsA. 64% PsAs patients were on Etanercept, 23% on Adalimumab, 9% on Infliximab and 4% Golimumab. PsAs patients had significantly higher DAS28 scores at baseline (5.2 v 4.1, p=0.006) yet lower 1yr DAS28 scores (1.5 v 2.6, p=0.003) compared to PsA. The ESR (2 v 16 v 13, p<0.01) and CRP (3 v 7 v 6, p=0.03) were significantly lower in PsAs compared to both AS and PsA pt’s at 1yr, respectively. Conclusions The PsAs group appear to be younger, more males and have higher DAS28 scores at baseline compared to PsA without spondylitis or AS patients. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 71(Suppl 3):574-574. DOI:10.1136/annrheumdis-2012-eular.3248 · 10.38 Impact Factor
  • P. Helliwell · O. FitzGerald · L. Marshall · R. Pedersen · E. Bananis ·

    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A684-A684. DOI:10.1136/annrheumdis-2013-eular.2022 · 10.38 Impact Factor
  • P. A. MacMullan · L. C. Harty · O. Fitzgerald ·
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    ABSTRACT: Background Patients with rheumatoid arthritis (RA) die prematurely from cardiovascular disease (CVD) with persistent inflammation likely playing an important role in the development of atherosclerosis. Conversely, induction of remission reduces CVD risk in RA. Methotrexate (MTX) monotherapy induces remission in 20% of RA patients v 55-80% remission with Tumour Necrosis Factor inhibitors (TNFi) and MTX combination therapy. Objectives (1) To evaluate the number of Myocardial Infarctions (MI) in RA patients discharged from hospital from 1995 to 2010; and (2) to assess any association with therapy, including TNFi usage. Methods The Hospital In-Patient Enquiry system (HIPE), a national system recording information on hospital bed utilization, was evaluated from 57 hospitals from 1995-2010 for patients admitted with a diagnosis of RA. Age group, number of inpatient days, gender and reason for admission (ICD codes) were also recorded. Annual prescription data for TNFi usage nationally was separately analysed from 2000 to 2010. Descriptive analyses are presented as totals, mean (standard deviation (SD)) and mean % change. Correlations were examined by Spearman’s rho; p<0.05 was considered statistically significant. Results 57,774 inpatient records in RA patients were reviewed from 1995-2010; F: M 2:1, mean age 66 (16). A total of 807 RA patients were discharged following admission for MI in this time period; F:M 1.4:1, mean age 71 (10). 53 per annum (pa) MI’s in RA were recorded from 1995-2000, increasing to 77pa up to 2004, with a subsequent 8%pa reduction to 2010 when 29 were recorded, reflecting a total 62% reduction in the annual incidence of MI’s in RA. At a national level, the total number of MI’s discharged pa increased from 6492 in 2000 to 8052 in 2010. The incidence ratio of MI’s in RA to total MI’s nationally decreased by 66% from 0.012 to 0.004 in this same period. Annual TNFi prescribing has increased by 156% per annum (pa) from 2389 units in 2000 to 116,747 in 2010. Increased prescription of TNFi negatively correlated with the annual incidence of MI in pt’s with RA (r=-0.7, p=0.015). Where information was available nationally (33% population), there was a trebling in the prescription of MTX from 2000-2010. Conclusions Increased prescription of TNFi drugs and likely also MTX has coincided with a 62% reduction in the annual incidence of MI’s in RA despite escalating national MI rates. Prescription of TNFi drugs strongly negatively correlated with the annual incidence of MI’s in RA with a concurrent increase in the prescription of MTX. It is recognised that factors other than TNFi usage, such as better control of traditional CVD risk factors may also have contributed to these improved patient outcomes. Disclosure of Interest None Declared
    Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A872-A872. DOI:10.1136/annrheumdis-2013-eular.2604 · 10.38 Impact Factor

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4k Citations
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  • 1999-2015
    • St Vincent's University Hospital
      Dublin, Leinster, Ireland
  • 1992-2013
    • St. Vincents University Hospital
      • Department of Rheumatology
      Dublin, Leinster, Ireland
  • 1975-2011
    • University College Dublin
      • • School of Medicine & Medical Science
      • • School of Chemistry and Chemical Biology
      Dublin, Leinster, Ireland
  • 2007
    • University of Limerick
      Luimneach, Munster, Ireland
  • 1992-2006
    • St. Vincent Hospital
      Green Bay, Wisconsin, United States
  • 2004
    • Repatriation General Hospital
      Tarndarnya, South Australia, Australia
  • 1960-2002
    • St. Vincent's Private Hospital
      Dublin, Leinster, Ireland
  • 1998
    • Dublin City University
      Dublin, Leinster, Ireland
  • 1973-1995
    • St. Vincent’s Hospital, Fairview
      Dublin, Leinster, Ireland
  • 1989-1991
    • Beaumont Hospital
      Dublin, Leinster, Ireland
  • 1976
    • Port of Spain General Hospital
      City of Port-of-Spain, City of Port of Spain, Trinidad and Tobago