Background:Biologic disease-modifying antirheumatic drug (bDMARD) therapy has been shown to be effective in the treatment of axial spondyloarthritis (axSpA).1,2 Little is understood about patients’ experience of axSpA treatment from their own perspective.Objectives:To characterize patient experiences and perspectives with bDMARD treatments for axSpA, including satisfaction, and use of supplementary treatments when wear-off between doses is perceived among those currently treated with bDMARD therapy.Methods:Adult US participants (pts) within the ArthritisPower registry with physician-diagnosed axSpA were invited to complete electronic PRO measures, such as the BASDAI (0-10 scale, score ≥4 indicates suboptimal disease control), and an online survey about their perspectives of treatment. Analysis compared pt characteristics and treatment satisfaction by whether or not pt reported wear-off between bDMARD doses.Results:128 pts with axSpA and on bDMARD therapy met inclusion criteria of whom 82.8% were female, with mean age of 47 years. Mean BASDAI scores indicated poor disease control (6.4, SD 1.8), worse for those perceiving wear-off between doses compared with those who did not [6.8 (1.6) vs. 5.9 (2.0), p=0.01]. A majority of pts on a bDMARD reported being somewhat (57.8%) or very satisfied (26.6%) with their current axSpA treatment, and about 53.1% were satisfied with how well it controls axSpA-related pain. However, 60.9% (n=78) of pts reported that their current bDMARD typically wears off before the next dose. Treatment satisfaction was lower for pts experiencing wear-off compared to pts without wear-off (highly satisfied: 21.8% vs. 34%; somewhat satisfied: 60.3% vs. 54%; dissatisfied: 17.9% vs. 12%). 82.1% (n=64) of pts reporting wear-off used additional medications or supplements when that happened, chiefly NSAIDs (68.8%, n=44), muscle relaxers (42.2%, n=27) and/or opioids (37.5%, n=24). Among the 20 pts not satisfied with current axSpA treatment, side effects (6/20, 30.0%), or worry about risk of side effects (2/20, 10%) were the main reasons.Conclusion:In a predominantly female sample of bDMARD-treated axSpA patients with high disease activity, most expressed satisfaction with treatment. However, most experienced wear-off between doses and took supplementary medications, including opioids, to manage.References:[1]Dubash S, et al. Ther Adv Chronic Dis. 2018;9(3):77–8.[2]Van Der Heijde D, et al. Ann Rheum Dis. 2017;76(6):978–91.Table 1.Demographic and clinical characteristics by wear-off between bDMARD doses (n=128)Pts currently on bDMARD(N=128)Wear-off between bDMARD oses(N=78)No wear-off / Not sure(N=50)p-valueNumber or mean (% or SD)Age46.9 (10.3)46.1 (9.2)48.2 (11.8)0.25Female106 (82.8)69 (88.5)37(74.0)0.03White115 (89.8)70 (89.7)45 (90.0)0.96Body Mass Index30.9 (7.8)31.2 (8.5)30.4 (6.6)0.57Current Medications, addition to bDMARDConventional Synthetic DMARD (e.g. methotrexate, sulfasalazine)17 (13.3)15 (19.2)2 (4.0)0.01Prescription NSAID59 (46.1)39 (50.0)20 (40.0)0.27Other prescription medication¥70 (54.7)44 (56.4)26 (52.0)0.62Noticed improvement in symptoms related to axSpA since starting current bDMARD80 (62.5)51 (65.4)29 (58.0)0.40Noticed improvement in symptoms NOT related to axSpA since starting current bDMARD40 (31.3)22 (28.2)18 (36.0)0.35BASDAI‡6.4 (1.8)6.8 (1.6)5.9 (2.0)0.01PROMIS Pain Interference ł65.3 (5.7)66.0 (5.1)64.3 (6.4)0.09PROMIS Physical Function ł36.7 (5.6)36.1 (5.3)37.7 (5.8)0.11PROMIS Sleep Disturbance ł59.8 (8.5)61.2 (7.7)57.6 (9.3)0.02* Statistical significance between groups of pts who experienced wear-off between bDMARD or not, p < 0.05¥ Other prescription medications: muscle relaxers, nerve pain medications or anti-depressants, and opioids‡ BASDAI is scored on a 0-10 scale with score ≥4 indicating suboptimal control of diseaseł PROMIS measures use T-score metric in which 50 is mean, 10 is standard deviation (SD), of US population; higher T-score = more of concept measuredAcknowledgements:This study was sponsored by Eli Lilly and Company. We thank the patients who participated in this study.Disclosure of Interests:W. Benjamin Nowell Grant/research support from: Full-time employee of Global Healthy Living Foundation, an independent nonprofit research organization, which received funding pursuant to a contract from Eli Lilly to conduct the study that is the subject of this abstract; Principal Investigator for studies with grant support from AbbVie, Amgen and Eli Lilly, Kelly Gavigan Grant/research support from: Full-time employee of Global Healthy Living Foundation, an independent nonprofit research organization, which received funding pursuant to a contract from Eli Lilly to conduct the study that is the subject of this abstract, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, William Malatestinic Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Lisse Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Carol Himelein Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Curtis Consultant of: AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, Radius, UCB, Grant/research support from: AbbVie, Amgen, BMS, Corrona, Eli Lilly, Janssen, Myriad, Pfizer, Roche, Regeneron, Radius, UCB, Jessica A. Walsh Consultant of: AbbVie, Amgen, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Merck, Pfizer
BackgroundIn the absence of reliable serological and/or imaging biomarkers that can support an early diagnosis of psoriatic arthritis (PsA) in patients with psoriasis (PsO), and considering the known diagnostic delay there is a need for screening tools for detection of early PsA. While different validated screening/referral tools focusing on peripheral manifestations of PsA exist, validated referral algorithms for PsA with axial involvement (also referred to as axial PsA - axPsA) are still missing.ObjectivesIn this prospective, multicenter study we applied a dermatologist-centered screening tool and a structured rheumatologic examination including magnetic resonance imaging (MRI) of sacroiliac joints (SIJs) and spine to detect axPsA in patients with psoriasis (PsO).MethodsPatients with PsO were systematically screened by their dermatologist for eligibility for referral to a rheumatology clinic. Eligible patients were ≥ 18 years with a confirmed diagnosis of PsO who reported having chronic back pain (≥ 3 months) with onset prior to 45 years of age and who had not been treated with any biologic or targeted synthetic DMARD 12 weeks prior to screening. For those patients who qualified for referral a rheumatologic investigation including clinical, laboratory and genetic assessments as well as imaging with conventional radiography and MRI of sacroiliac joints and spine was performed. The primary outcome of the study was the proportion of patients diagnosed with axPsA among all referred PsO patients.ResultsIn total 355 patients were screened at 14 dermatology sites, of whom 151 (42.5%) qualified for referral to rheumatology clinic and 100 (28.2%) were seen by a rheumatologist. The diagnosis of axPsA was confirmed in 14 patients (3/14 with both, axial and peripheral involvement) and the diagnosis of peripheral PsA (pPsA) without axial involvement was made in five patients. The ASAS classification criteria for axSpA were fulfilled in nine (64.3%) of the patients diagnosed with axPsA. All but one patient diagnosed with PsA (13/14 with axPsA and 5/5 with pPsA) fulfilled the CASPAR criteria for PsA.Patient characteristics are presented in Table 1. All patients diagnosed with axPsA had active inflammatory and/or structural (post)inflammatory changes in the sacroiliac joints and/or spine on imaging. In five patients (35.7%), MRI changes indicative of axial involvement were found only in the spine as illustrated in Figure 1.Table 1.Clinical characteristics of all referred patients with PsO and suspicion of axSpA.Patient characteristicpPsA (N=5)axPsA (N=14)No PsA (N=81)p-value1Age (years) – Mean (SD)42.8 (9.0)46.2 (13.6)45.7 (13.3)0.883Female – n (%)2 (40.0)9 (64.3)45 (55.6)0.543PASI – Mean (SD)3.3 (2.1)4.3 (4.9)4.0 (4.5)0.971Inflammatory back pain – n (%)5 (100.0)8 (57.1)36 (44.4)0.379HLA-B27 positive – n (%)04 (28.6)12 (14.8)0.204Elevated CRP (>5 mg/L) – n (%)1 (20.0)5 (35.7)11 (13.6)0.041Peripheral arthritis, current (last 7 days) – n (%)5 (100.0)3 (21.4)3 (3.7)0.012Radiographic sacroiliitis as per mNY criteria – n (%)04 (28.6)1 (1.2)<0.001Active inflammation, sacroiliac joint (MRI) – n (%)08 (57.1)0<0.001Structural (post)inflammatory changes, sacroiliac joint (MRI) – n (%)08 (57.1)0<0.001Active inflammation, spine (MRI) – n (%)013 (92.9)0<0.001Structural (post)inflammatory changes, spine (MRI) – n (%)08 (57.1)0<0.0011Statistically significant differences between the axPsA and No PsA groups of patients were determined by using Mann–Whitney U test for continuous data and Chi-square test for categorical dataFigure 1.Imaging features of axial involvement in PsO patients diagnosed with axPsAConclusionOur study revealed that applying a dermatologist-centered screening tool may be useful for the early detection of patients with a high probability of PsA (and specifically axPsA) in PsO patients. Given the high prevalence of isolated spinal involvement (without SIJs), imaging of the entire axial skeleton may be required as a part of diagnostic procedure in patients with suspected axPsA.AcknowledgementsCaroline Höppner, Rebecca Bolce, David Sandoval, Hagen Russ, Burkhard Muche, Judith Rademacher, Hildrun Haibel, Laura Spiller and all cooperating dermatologists.Disclosure of InterestsFabian Proft: None declared, Susanne Lüders: None declared, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Gustavo Luna: None declared, Valeria Rios Rodriguez: None declared, Mikhail Protopopov: None declared, Katharina Meier: None declared, Georgios Kokolakis: None declared, Kamran Ghoreschi: None declared, Denis Poddubnyy: None declared
the National Healthcare Group Diabetes Registry. All patients were followed up for at least 1 year and the outcomes of interest were death from all causes. The mortality data was obtained from the national death registry. Results: There were a total of 3,792 lower extremity amputations performed from 1 January 2008 to 31 December 2013. The mean age at amputation was 63.6 years and the mean age at death was 68.9 years. 197 patients (7.8%) died within 30 days and 577 patients (22.8%) died within 1 year. Those who died were older (68.9 years) compared to those who survivied. (62.0 years) The 30-day mortality rate was 6.3% in 2008 and it decreased steadily to 3.8% in 2013. However, the 1-year mortality rate remained constant from 19.8% in 2008 to 20.1% in 2013. ConClusions: The 1-year mortality rates of diabetes patients who underwent lower extremity amputations remained high even though 30-days mortality rates have seen a gradual decline. Further research is needed to address this high mortality rate and further interventions is are needed to prevent lower extremity amputations in patients with diabetes mellitus.
Background:Axial spondyloarthritis (axSpA) is a chronic inflammatory disease of the axial skeleton comprising two subtypes within the same spectrum: radiographic (r-axSpA) and non-radiographic (nr-axSpA). Previous studies have shown that clinical presentation and treatment response of males and females may differ1 despite similar disease burden.2 Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, has demonstrated superior efficacy to placebo in the treatment of patients with r-axSpA (COAST-V/W [bDMARD- naïve/TNFi-experienced]) and nr-axSpA (COAST-X [bDMARD-naïve]).3Objectives:Assess baseline characteristics and treatment response to IXE categorised by sex in patients with r-axSpA and nr-axSpA for up to 52 weeks.Methods:Patients fulfilled the ASAS classification criteria for r-axSpA or nr-axSpA. Patients were randomized to receive 80 mg subcutaneous IXE every 2 weeks (Q2W) or 4 weeks (Q4W), or to placebo (PBO) [16 weeks COAST-V/W; 52 weeks COAST-X]. Baseline characteristics and treatment outcomes were assessed. Patients were categorised by sex, missing data was controlled for using non-responder imputation (NRI) and modified baseline observation carried forward (mBOCF) analysis was conducted on continuous efficacy variables.Results:At baseline, females were older, with significantly higher pain and fatigue scores and peripheral joint symptoms (table 1). ASAS40 response rate with IXEQ4W was achieved in 39% of males with r-axSpA by week 16, and 44% by week 52. Females achieved 16.7% at week 16, and 33.3% at week 52. In nr-axSpA, 46% of IXEQ4W males achieved ASAS40 at week 16 and 30% at week 52. 23.9% of females achieved ASAS40 at week 16, increasing to 30.4% at week 52.Table 1.Baseline Characteristics of Patients Categorised by SexPatients with r-axSpA(COAST-V/W)(n=376)Patients with nr-axSpA(COAST-X)(n=198)CharacteristicMale (n=298)Female (n=78)p valueMale (n=99)Female (n=99)p valueAge at onset (yrs), mean (SD)26.5 (8.7)30.1 (10.1)0.002*27.9 (7.7)32.0 (10.7)0.002*Symptom duration (yrs), mean (SD)16.7 (10.5)17.8 (12.2)0.4209.5 (9.2)12.3 (11.3)0.057ASDAS, mean (SD)4.0 (0.8)3.9 (0.7)0.3043.7 (0.8)3.9 (0.8)0.143BASDAI, mean (SD)7.10 (1.4)7.4 (1.5)0.1796.9 (1.4)7.4 1.4)0.013*Fatigue/tiredness (BASDAI Q1), mean (SD)7.4 (1.6)7.8 (1.5)0.036*7.0 (1.6)7.9 (1.5)<0.001*Spinal pain (BASDAI Q2), mean (SD)7.9 (1.5)8.0 (1.5)0.6827.5 (1.4)7.9 (1.5)0.029*Pain/swelling in other joints (BASDAI Q3), mean (SD)6.5 (2.1)6.9 (2.2)0.1296.6 (2.3)7.2 (1.9)0.039*Tenderness to touch/pressure (BASDAI Q4), mean (SD)6.8 (1.8)7.0 (1.9)0.3396.6 (1.9)6.8 (1.8)0.404Morning stiffness (BASDAI Q5), mean (SD)7.5 (1.6)7.7 (1.8)0.5047.3 (1.7)7.7 (1.9)0.137Morning stiffness duration (BASDAI Q6), mean (SD)6.5 (2.3)6.5 (2.8)0.9446.3 (2.3)6.6 (2.5)0.392Spinal pain at night NRS, mean (SD)7.4 (1.5)7.8 (1.7)0.033*7.0 (1.8)7.6 (1.8)0.027*BASFI, mean (SD)6.8 (1.8)7.0 (2.0)0.4666.2 (1.8)6.7 (2.1)0.108SF-36 PCS, mean (SD)30.9 (8.3)28.9 (8.2)0.07533.1 (7.7)32.1 (7.2)0.348p-value from Fisher’s exact test analysis of variance (ANOVA) with sex as a factor for continuous data. Data includes pooled IXEQ2W and IXEQ4W.Conclusion:This analysis demonstrates that for the axSpA disease spectrum, females present with higher disease burden as reflected by higher scores in fatigue/tiredness, and spinal pain at night. Our findings indicate that males and females respond to IXE; however, females experience this benefit later in their treatment course, with a more prolonged attainment of peak response.References:[1]van der Horst-Bruinsma IE, et al. Ann Rheum Dis. 2019;78:1550-1558.[2]Zhao SS, et al. Rheumatology. 2019;58:2025-2030.[3]Deodhar A, et al. Lancet. 2020;395:53-64.Figure 1.COAST-V/W ASAS40 (ITT, NRI) Patients initially randomized to PBO in COAST-V/W switched to IXEQ2W or Q4W at week 16 by study design; PBO data are summarised up to week 16.Acknowledgements:Writing support was provided by Dr Geraldine Fahy, an employee of Eli Lilly and CompanyDisclosure of Interests:Irene van der Horst-Bruinsma Speakers bureau: BMS, AbbVie, Pfizer, UCB, MSD, Consultant of: Abbvie, UCB, MSD, Lilly, Novartis, Grant/research support from: MSD, Pfizer, AbbVie, Rebecca Bolce Shareholder of: Eli Lilly, Employee of: Eli Lilly, Theresa Hunter Shareholder of: Eli Lilly, Employee of: Eli Lilly, David Sandoval Shareholder of: Eli Lilly, Employee of: Eli Lilly, Danting Zhu Employee of: Eli Lilly, Vladimir J. Geneus Employee of: Eli Lilly, Jeffrey Lisse Shareholder of: Eli Lilly, Employee of: Eli Lilly, Soyi Liu Leage Shareholder of: Eli Lilly, Employee of: Eli Lilly, Marina Magrey Consultant of: Novartis, Eli Lilly, Pfizer, Abbvie, UCB and Jansen, Grant/research support from: Amgen, AbbVie, and UCB Pharma
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