SAT0435 SECUKINUMAB EFFICACY In PsA PATIENTS IS DEPENDENT ON PATIENTS’ BODY MASS INDEX

Background:Psoriatic arthritis (PsA) is a chronic inflammatory arthritis burdened by a series of metabolic comorbidities. Among them, obesity is very common in PsA, with a prevalence of 27%, as confirmed by a recent Spanish work (1). Obesity in PsA has been associated with higher disease activity and a worse effectiveness of biologic treatment in PsA. This has been certainly proven for anti-TNF-α as demonstrated by different studies reporting, in obese patients, a reduced treatment response and adherence. In particular, results coming from DAN-BIO and ICE-BIO registries, (2) point out that obesity is a risk factor for anti-TNF withdrawal due to poor response. Although a recent multi-centric, retrospective study in Spain has shown that obese subjects with psoriasis have a poor therapeutic response to secukinumab, (3) no data are currently available for secukinumab in PsA obese patients.Objectives:Our studies focused on the relationship between BMI and clinical response to secukinumab in PsA.Methods:We, retrospectively, analysed clinical data of 100 patients with PsA (57% female, median age 53 (49.2-55 years)) satisfying CASPAR criteria (4) for PsA, afferent to our clinic, who were treated with secukinumab. Patients were divided into 2 groups based on BMI (BMI<25 normal weight and BMI≥25 overweight/obese).Results:In the normal weight group 75% were female, median age was 50.5 (41-54.6), median BMI was 22 (20.2-23.3) and median DAPSA was 19.19 (15.6-24.2). The features of the overweight/obese patients were similar to the normal weight group (48% were female, median age 54 (50-59), median BMI 29 (27.4-30.1) and median DAPSA 21.2 (19-24.4)). Clinical response to therapy, evaluated as the achievement of low disease activity or remission according to DAPSA, was recorded 6 months after starting treatment. After 6 months of treatment, the variation of the DAPSA was inversely related to BMI: overweight/obese patients had in fact a better response to secukinumab compared to normal weight patients. By using a correlation coefficient (SPSS), to analyze the degree of association between BMI and DAPSA, we observed that BMI and DAPSA are inversely related in our PsA patients (p=0.05). Interestingly, analysis of serum levels of IL-17 in 20 obese patients compared to 20 non-obese patients, showed significantly higher serum levels of IL-17 in the former (Figure 1), indicating IL-17 as a key cytokine driving inflammation in PsA obese patients.Conclusion:These are the first data about clinical response to secukinumab in obese PsA patients. Our results support the relevance of IL-17 in driving systemic inflammation in obese PsA patients, also providing evidence that obese patients may have a better response to secukinumab compared to non-obese patients. Interestingly, this effect was notReferences:[1]Rubén Queiro, Lorenzo A, Tejón P et al. Obesity in psoriatic arthritis. Comparative prevalence and associated factors. Medicine 2019 Jul;98(28):e16400[2]Pil Højgaard, Glintborg B, Kristensen LE et al. The influence of obesity on response to tumour necrosis factor-a inhibitors in psoriatic arthritis:results from the DANBIO and ICEBIO registries. Rheumatology (Oxford). 2016 Dec;55(12):2191-2199[3]Jaime Notario, Deza G, Vilarrasa E et al. Treatment of patients with plaque psoriasis with secukinumab in a real-life setting: a 52-weeks, multicenter, retrospective study in Spain. Journ of Derm Treat 2019 Aug;30(5):424-429[4]Taylor W, Gladman D, Helliwell P et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006 Aug;54(8):2665-73.[5]Lluís Puig. Cardiometabolic Comorbidities in Psoriasis and Psoriatic Arthritis. Int J Mol Sci. 2017 Dec 25;19(1).Disclosure of Interests:Ilenia Pantano: None declared, DANIELA IACONO Speakers bureau: PFIZER, BRISTOL MAYERS SQUIBB, SANOFI, ENNIO GIULIO FAVALLI: None declared, GIUSEPPE SCALISE: None declared, Luisa Costa: None declared, Francesco Caso: None declared, Giuliana Guggino Grant/research support from: Pfizer, Celgene, Speakers bureau: Celgene, Sandoz, Pfizer, Raffaele Scarpa: None declared, francesco ciccia Grant/research support from: pfizer, novartis, roche, Consultant of: pfizer, novartis, lilly, abbvie, Speakers bureau: pfizer, novartis, lilly, abbvie

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POS0212 COMPARISON OF PATIENT CHARACTERISTICS AND TREATMENT PATTERNS ACROSS BODY MASS INDEX CATEGORIES IN PATIENTS WITH PSORIATIC ARTHRITIS AND RHEUMATOID ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1348 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 323.2-324

Author(s):

E. Vallejo-Yagüe ◽

T. Burkard ◽

B. Moeller ◽

A. Finckh ◽

A. M. Burden

Keyword(s):

Body Mass Index ◽

Disease Activity ◽

Body Mass ◽

Patient Characteristics ◽

Normal Weight ◽

Obese Patients ◽

Weight Group ◽

Normal Weight Group ◽

Treatment Start ◽

Prevalence Of Obesity

Background:Higher prevalence of obesity has been observed in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) versus the general population, and abnormal body mass index has been associated with worse rheumatic markers.Objectives:To describe PsA and RA patients in Switzerland, stratified by body mass index (BMI) category.Methods:We performed a descriptive cohort study in PsA and RA patients registered in the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) database. Two distinct cohorts were generated based on patient diagnosis (PsA or RA) and analysed separately but using similar approaches. In both cohorts, we included patients treated for the first time with biologics or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs), and considered the treatment start as index date. Patients without baseline BMI were excluded. Patients were stratified by BMI category at the start of biologic/tsDMARD treatment, defined as underweight (BMI<18.5), normal weight (BMI 18.5-24.9), overweight (BMI 25.0-29.9), and obese (BMI≥30). In the PsA cohort, underweight and normal weight groups were merged due to low numbers. The proportion of patients categorized as overweight or underweight were compared to national statistics from the Swiss Federal Statistical Office. Information on patient demographics (e.g., age, sex, BMI, life-habits), disease-specific characteristics (e.g., disease activity scores, health questionnaires, biomarkers), co-medications and comorbidities were summarized at the start of the first biologic/tsDMARD treatment. Patient characteristics across BMI categories were compared, using the normal weight category as reference group. Additionally, we summarized the frequency and reasons for recorded treatment stop/switch at ≤6 months, 6 to 12 months, and >12months from treatment start, and illustrated the prescription patterns for first and second biologic/tsDMARD treatment, stratifying by BMI.Results:We identified 819 PsA [39.7% normal weight, 36.5% overweight, 23.8% obese] and 3217 RA patients [4.4% underweight, 46.8% normal weight, 31.8% overweight, 17.0% obese]. Figure 1 illustrates the prevalence of overweight and obesity in each cohort stratified by sex, compared to the national average. When comparing obese patients to those with normal weight, both PsA and RA obese patients had significantly higher C-reactive protein, worse disease activity score, lower quality of life (QoL) measures, and more frequent cardiovascular disease and diabetes. Among PsA patients, the overweight and obese had worse physician-assessed skin manifestation and patient-reported pain compared to the normal weight group. While in RA, the obese patients had higher erythrocyte sedimentation rate, smaller prevalence of seropositive patients, lower frequency of fractures/surgeries, and higher tender joint counts, but similar swollen joint counts, when compared to the normal weight group.Adalimumab and etanercept, were the most commonly prescribed drugs as first biologic/tsDMARD treatment in both PsA and RA cohorts and among every BMI category. Overall, 55% PsA and 56% RA patients had recorded treatment stop/switch. Among RA patients, significantly fewer obese patients reported treatment stop/switch at >12 months from treatment start, compared to the normal weight group. Adalimumab and etanercept were also the most commonly prescribed second biologic/tsDMARD treatment, but for the obese group among PsA patients (adalimumab, golimumab) and the obese group in the RA cohort (adalimumab, rituximab).Conclusion:In this national wide study, we observed that the prevalence of obesity in RA and PsA was higher than that of the general Swiss population. Obese PsA/RA patients starting first biologic/tsDMARD treatment presented worse disease activity and poorer QoL than normal weight patients. Results suggest to take BMI into consideration when treating PsA and RA patients.Acknowledgements:We would like to thank all patients and rheumatologists contributing to the SCQM registry, as well as the entire SCQM staff. A list of rheumatology offices and hospitals which contribute to the SCQM registry can be found at http://www.scqm.ch/institutions. The SCQM is financially supported by pharmaceutical industries and donors. A list of financial supporters can be found at http://www.scqm.ch/sponsors.Disclosure of Interests:Enriqueta Vallejo-Yagüe: None declared, Theresa Burkard: None declared, Burkhard Moeller Speakers bureau: AbbVie, Bristol Myers, Eli Lilly, Janssen, Pfizer, Roche, Novartis, Merck, Axel Finckh Speakers bureau: Pfizer, Eli-Lilly, Paid instructor for: Pfizer, Eli-Lilly, Consultant of: AbbVie, AB2Bio, BMS, Gilead, Pfizer, Viatris, Grant/research support from: Pfizer, BMS, Novartis, Andrea Michelle Burden: None declared

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The impact of obesity on orthodontic treatment outcome in adolescents: a prospective clinical cohort study

European Journal of Orthodontics ◽

10.1093/ejo/cjaa032 ◽

2020 ◽

Author(s):

Hayder F Saloom ◽

Roshanak Boustan ◽

Jadbinder Seehra ◽

Spyridon N Papageorgiou ◽

Guy H Carpenter ◽

...

Keyword(s):

Cohort Study ◽

Treatment Outcome ◽

Treatment Duration ◽

Orthodontic Treatment ◽

Normal Weight ◽

Obese Patients ◽

Weight Group ◽

Normal Weight Group ◽

Clinical Cohort ◽

Pre Treatment

Summary Introduction This prospective clinical cohort study investigated the potential influence of obesity on orthodontic treatment outcome. Methods A prospective cohort of adolescent patients undergoing routine fixed appliance treatment were recruited into normal-weight or obese groups based upon body mass index (BMI) centile and followed up until the completion of treatment. Primary outcome was treatment duration, and secondary outcomes included treatment outcome (occlusal change measured using peer assessment rating [PAR]), appointment characteristics, and compliance measures. Results A total of 45 patients mean age 14.8 (1.6) years were included in the final analysis. The normal-weight group included 23 patients with mean BMI 19.4 (2.4) kg/m2 and the obese group 22 patients with mean BMI 30.5 (3.8) kg/m2. There were no significant differences in baseline demographics between groups, except for BMI and pre-treatment PAR. The normal-weight group had a mean pre-treatment PAR of 25.6 (8.3) and the obese 33.3 (11.8) giving the obese group a more severe pre-treatment malocclusion (P = 0.02). There were no significant differences in treatment duration between groups (P = 0.36), but obese patients needed less time per each additional baseline PAR point compared to normal weight (P = 0.02). Obese patients also needed less appointments compared to normal-weight patients (P = 0.02). There were no significant differences between groups for appointment characteristics or compliance. Finally, obese patients were more likely to experience a great PAR reduction than normal-weight patients (relative risk = 2.6; 95% confidence interval = 1.2–4.2; P = 0.02). Conclusions There were no significant differences in treatment duration between obese and normal-weight patients. Obesity does not appear to be a risk factor for negative orthodontic treatment outcome with fixed appliances.

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The interaction of obesity and craniofacial deformity in obstructive sleep apnea

Dentomaxillofacial Radiology ◽

10.1259/dmfr.20200425 ◽

2020 ◽

pp. 20200425

Author(s):

Liping Huang ◽

Xuemei Gao

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Soft Tissues ◽

Normal Weight ◽

The Body ◽

Apnea Hypopnea Index ◽

Obese Patients ◽

Weight Group ◽

Normal Weight Group ◽

Obstructive Sleep

Objective: Both obesity and craniofacial deformity are important etiologies of obstructive sleep apnea (OSA). The present research aimed to explore their interaction and different impacts on OSA severity. Methods: A total of 207 consecutive OSA patients (169 males, 38 females) were included in the research. Based on the body mass index (BMI) value, patients were divided into 77 normal-weight patients (BMI <24 kg m−2), 105 overweight patients (24 ≤ BMI<28 kg m−2) and 26 obese patients (BMI ≥28 kg m−2). All accepted overnight polysomnography and standard lateral cephalogram. Cephalometric measurements involved 25 cephalometric variables. The correlations between these cephalometric variables, BMI and the apnea-hypopnea index (AHI) were evaluated. Results: For the whole sample after controlling for gender and age, stepwise regression analysis showed that the factors affecting AHI were increased BMI, narrowing posterior airway space, inferior displacement of hyoid and elongation of the tongue. When grouped by BMI, normal-weight group exhibited with more reduced maxillary length and mandible length, and steeper mandible plane than overweight and obese patients (p < 0.0167). Obese group showed least skeletal restriction and most prominent soft tissues enlargement (p < 0.0167). However, these skeletal indexes were not statistically correlated with AHI. Conclusions: Obesity and skeletal malformations were both etiological factors of OSA, but obesity seemed to have a greater influence on AHI severity in all kinds of obese and thin OSA patients. Only in normal-weight group, it was affected by both cephalometric variables and BMI.

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Effect of overweight and obesity on the left ventricular systolic and diastolic functions in patients with acute myocardial infarction

Clinical & Investigative Medicine ◽

10.25011/cim.v35i4.17152 ◽

2012 ◽

Vol 35 (4) ◽

pp. 229 ◽

Cited By ~ 2

Author(s):

Fatih Poyraz ◽

Murat Turfan ◽

Sinan A. Kocaman ◽

Huseyin U. Yazici ◽

Nihat Sen ◽

...

Keyword(s):

Myocardial Infarction ◽

Diastolic Function ◽

Systolic Function ◽

Study Groups ◽

Left Ventricular ◽

Normal Weight ◽

Overweight And Obesity ◽

Weight Group ◽

Normal Weight Group ◽

Diastolic Functions

Purpose: The purpose of this study was to evaluate whether a association exits among overweight and obesity and left ventricular systolic and diastolic functions in patients admitted with first ST-elevation myocardial infarction (STEMI). Methods: The present study was performed on 451 consecutive patients diagnosed with first STEMI (376 men, 75 women; mean age 56.1±10.8 years). The patients were classified into three groups based on their body mass index (BMI) as normal weight (BMI < 25 kg/m2), overweight (BMI: 25-29.9 kg/m2) and obese (BMI > 30 kg/m2). Echocardiographic features were evaluated and compared among the three groups. Results: Mitral annulus E velocities were higher in obese individuals than normal weight group (p < 0.01). In contrast, mitral A velocities were lower (p =0.03); consequently, E\A and E'\A' ratios were lower (both p =0.01) in the obese group with respect to normal weight group. When the correction of entire variations existing among the groups were performed using multivariate linear regressions analyses, it turned out that BMI was independently associated with E/A (β= -0.19, p =0.044) and with E'/A' (β= -0.016, p=0.021). Ejection fraction, wall motion score index and myocardial S velocities were comparable among the study groups (p > 0.05). Conclusion: These results suggest that while obesity has no adverse effect on the left ventricular systolic function, it has unfavorable consequences on the left ventricular diastolic function in the patients with first STEMI. In contrast, no unfavorable effects of overweight on the left ventricular systolic and diastolic function were detected.

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Physical Characteristics Vary According to Body Mass Index in Japanese Community-Dwelling Elderly Women

Geriatrics ◽

10.3390/geriatrics3040087 ◽

2018 ◽

Vol 3 (4) ◽

pp. 87 ◽

Cited By ~ 3

Author(s):

Koji Nonaka ◽

Shin Murata ◽

Kayoko Shiraiwa ◽

Teppei Abiko ◽

Hideki Nakano ◽

...

Keyword(s):

Body Mass Index ◽

Walking Speed ◽

Elderly Women ◽

Knee Extension ◽

Normal Weight ◽

Physical Characteristics ◽

Community Dwelling ◽

Weight Group ◽

Normal Weight Group ◽

Knee Extension Strength

Background: Body mass index (BMI) is related to health in the elderly. The purpose of this study was to investigate the physical characteristics in underweight, overweight, and obese Japanese community-dwelling elderly women compared to normal-weight elderly women. Methods: The study participants included 212 community-dwelling elderly women. They were categorized as underweight (BMI < 18.5), normal weight (18.5 ≤ BMI ≤ 22.9), overweight (23 ≤ BMI ≤ 24.9), and obese (BMI ≥ 25). Data on skeletal muscle mass index (SMI), number of trunk curl-ups performed within 30 seconds, knee extension strength, one-leg standing time, and walking speed were recorded. Results: In the underweight group, the number of trunk curl-ups was significantly lower than that of the normal-weight group (p = 0.011) and the correlation between knee extension strength and walking speed was relatively higher than in the normal-weight group (r = 0.612 vs. r = 0.471). In the overweight group, the SMI was significantly increased (p < 0.001), but knee extension strength was not increased (p = 0.235) compared to that of the normal-weight group. In the obese group, one-leg standing time was significantly shorter than in the normal-weight group (p = 0.016). Conclusions: Physical characteristics vary according to BMI and these findings are useful in assessing and planning interventional programs to improve and maintain physical function in elderly women.

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AB0542 EVALUATION OF APREMILAST USE IN THE ROUTINE CLINICAL PRACTICE IN PATIENTS WITH PSORIATIC ARTHRITIS NAÏVE TO BIOLOGICAL TREATMENTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1621 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1303.2-1304

Author(s):

J. Gratacos-Masmitja ◽

J. L. Álvarez Vega ◽

E. Beltrán ◽

A. Urruticoechea-Arana ◽

C. Fito-Manteca ◽

...

Keyword(s):

Clinical Practice ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Routine Clinical Practice ◽

Wilcoxon Test ◽

Psychiatric Disease ◽

Biological Therapies ◽

Research Support ◽

Disease Evolution ◽

Biological Treatments

Background:Apremilast is a non-biologic systemic agent approved for the treatment of plaque psoriasis, oral ulcers of Behcet’s disease and PsA with proven efficacy in clinical trials [1,2]. However, more real-world evidence of apremilast use and effectiveness is needed to identify the patient profile most likely to benefit from this treatment [3].Objectives:To evaluate the persistence of apremilast treatment in patients with PsA naïve to biological treatments in routine clinical practice and assess its effectiveness. Baseline clinical characteristics on patients who started apremilast were also evaluated.Methods:Observational, prospective, multicenter (20 centers) study including consecutive adult patients with PsA naïve to biological therapies who had started treatment with apremilast during the previous 5 to 7 months and were followed-up during 12 months. Variables recorded were persistence of treatment with apremilast at 6 months (6mo) and number of swelling joints, presence of enthesitis and dactylitis, and disease activity, measured by the Disease Activity in Psoriatic Arthritis (DAPSA) score and Physician Global Assessment (PGA) of psoriasis, collected at baseline (BL) (i.e., apremilast treatment start) and 6mo; comorbidities were retrospectively collected at BL. Categorical and quantitative variables were compared using McNemar’s and Wilcoxon test, respectively. Data sets analyzed included all assessable patients.Results:Of the 60 patients recruited at the time of this interim analysis, 54 (90.0%) [mean (SD) age 53.4 (13.9) years] were assessable; 41 (75.9%) of these continued treatment with apremilast at 6mo. At BL, 34 (63.0%) patients had at least one comorbidity, the most frequent being cardiovascular disease (n=15, 27.8%), including hypertension (n=8, 14.8%), metabolic/endocrine disease (n=18, 33.3%), including obesity (n=8, 14.8%) and dyslipidemia (n=10, 18.5%). Psychiatric disease (i.e., depression) (n=5, 9.3%) and neoplasia (n=8, 14.8%) were also observed. The number of swelling joints decreased from median (Q1, Q3) 4.0 (2.0, 7.0) at BL to 1.5 (0.0, 4.0) at 6mo (p=0.0012). Patients with dactylitis and enthesitis decreased from 19 (35.2%) and 16 (29.6%) at BL to 10 (18.5%) and 9 (16.7%) at 6mo (p=0.0225 and p=0.0391), respectively. The distribution of patients in the different disease activity categories according to DAPSA scale changed between BL and 6mo, indicating a favorable disease evolution (Figure 1 next page). According to PGA, at BL (n=53), disease activity was categorized as mild in 18.0%, as moderate in 72.0%, and as severe in 10% of patients and, at 6mo (n=54), as mild in 70.6%, as moderate in 25.5%, and as severe in 3.9% of patients. Fifteen (27.8%) patients interrupted treatment permanently (n=13, 24.1%) or temporarily (n=2, 3.7%), due to no/partial response (n=8, 14.8%), tolerability issues leading to adverse events (n=3, 5.6%), patient decision (n=2, 3.7%), and other reasons (n=2, 3.7%) after a mean (SD) treatment of 3.05 (2.20) months.Conclusion:Forty-one (75.9%) patients with PsA naïve to biological therapies were treated with apremilast during ≥6 months. After treatment, the number of swelling joints, and dactylitis and enthesitis decreased and changes in disease activity according to DAPSA and PGA pointed to a favorable disease evolution. Apremilast treatment provides a clinical benefit to patients with PsA treated in clinical practice.References:[1]Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Feb 10;75(3):499 LP-510[2]Torres T and Puig L. Apremilast: A novel oral treatment for psoriasis and psoriatic arthritis. Am J clin Dermatol. 2018 Feb;19(1):23-32[3]Coates LC, Kavanaugh A, Mease PJ et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis 2015. Treatment Recommendations for Psoriatic Arthritis. Arthritis Rheumatol. 2016;68(5):1060– 71.Disclosure of Interests:Jordi Gratacos-Masmitja Speakers bureau: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., Consultant of: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Celgene y Lilly., José Luis Álvarez Vega Speakers bureau: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Consultant of: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Grant/research support from: Abbvie, Amgen, MSD, Lilly, Roche, Esteve, UCB, Menarini, Pfizer, GSK, BMS, Janssen, Novartis, Gebro., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, ANA URRUTICOECHEA-ARANA: None declared., C. Fito-Manteca: None declared., Francisco Maceiras: None declared., Joaquin Maria Belzunegui Otano Speakers bureau: Lilly, Amgen, Novartis, Abbvie, Janssen., J. Fernández-Melón Speakers bureau: Amgen SL, Eugenio Chamizo Carmona: None declared., Abad Hernández Speakers bureau: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Consultant of: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Grant/research support from: MSD, Abbvie, Pfizer, Kern, Novartis, Biogen, Sandoz, Amgen, Sanofi, Lilly, Roche and Janssen-Cilag, Inmaculada Ros Consultant of: Amgen, Grant/research support from: MSD, Roche, Novartis, lilly, Pfizer, Amgen, Eva Pascual Shareholder of: Amgen, Employee of: Amgen, Juan Carlos Torre Speakers bureau: Amgen, Lilly, Novartis, Janssen, Pfizer, Consultant of: Amgen, Lilly, Novartis, Janssen, Pfizer, Grant/research support from: Amgen, Lilly, Novartis, Janssen, Pfizer.

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SAT0432 EFFECT OF SEX ON DISEASE CHARACTERISTICS AND DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS (PsA): INSIGHTS FROM THE REAL-WORLD, OBSERVATIONAL MULTINATIONAL PsABio COHORT

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2771 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1171.1-1173

Author(s):

M. T. Nurmohamed ◽

I. Van der Horst-Bruinsma ◽

A. W. Van Kuijk ◽

S. Siebert ◽

P. Bergmans ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Physical Functioning ◽

Real World ◽

Comprehensive Treatment ◽

Diagnosis Delay ◽

Health State ◽

Research Support ◽

Disease Characteristics ◽

Disease Impact

Background:Female sex has been associated with more severe disease and poorer treatment outcomes in PsA. These observations are often based on small populations or national cohorts/registries.Objectives:To investigate the effects of sex on disease characteristics and disease impact in PsA, using data of 929 consecutive patients (pts) from PsABio.Methods:PsABio is a real-world, non-interventional European study in PsA pts treated with UST or TNFi based on their rheumatologist’s choice. Observed male and female baseline (BL) data were described and compared using 95% CI.Results:Women in PsABio (n=512 [55%]) were numerically older than men (mean [SD]: 50.5 [12.7] / 48.7 [12.3] years, respectively). Women were more obese (BMI >30), % (95% CI): F: 35 (30, 39), M: 24 (20, 29), men more overweight (BMI >25–30): F: 31 (27, 36), M:51 (46, 57). Age at diagnosis, delay from first symptom to diagnosis, and disease duration were similar for both sexes.Women entered PsABio more often on 3rd line treatment, whereas men started on 1st-line biologic treatment more often (F/M 1st line 47%/55%; 2nd line 34%/33%; 3rd line 20%/12%). Numerically, concomitant MTX was given more often to women vs men (32% vs 27%). At BL, 60% of women and 64% of men were on NSAIDs; 7.9% and 2.5% on antidepressant drugs. Women had significantly more comorbidities, with numerically more cardiovascular disease and anxiety/depression, and 3 times more IBD.Women had significantly higher 68 tender joint counts (TJC): 13.0 vs 10.4, while 66 swollen joint counts were not significantly different: 5.8 vs 5.5. Axial or combined axial-peripheral disease was similarly frequent, in 29% of women and 26% of men (Figs. 1, 2).Clinical Disease Activity index for PSoriatic Arthritis (cDAPSA) was higher in women (31.8 vs 27.3); pt-reported levels of pain, global disease activity (VAS scales) and higher TJC contributed to this. While enthesitis prevalence (based on Leeds Enthesitis Index) was comparable, men had significantly more frequent dactylitis, nail disease and worse skin psoriasis. At BL, 3.4% of women vs 7.1% of men, were in MDA.Regarding physical functioning (HAQ-DI), impact of disease (PSAID-12) and quality of life (EQ5D-3L health state), women with PsA starting a biologic (b)DMARD, expressed significantly greater negative impact and more limitations due to their disease (Fig. 2).Conclusion:In routine care, women with PsA starting a bDMARD presented with worse outcomes over a range of assessments compared with men (higher pt-reported pain and disease activity, TJC, and worse physical functioning and QoL), while men had worse dactylitis and psoriasis. Follow-up analysis will report whether the effects of biologic therapy are different in both sexes. The increased prevalence of associated features related to pain and impact on functioning and QoL may indicate the need for a more comprehensive treatment approach for women to avoid unnecessary and premature bDMARD stop or switch.Acknowledgments:This study was funded by Janssen.Disclosure of Interests:Michael T Nurmohamed Grant/research support from: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Consultant of: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Speakers bureau: Abbvie, Bristol-Myers Squibb, Celltrion, GlaxoSmithKline, Jansen, Eli Lilly, Menarini, Merck Sharp & Dohme, Mundipharma, Pfizer, Roche, Sanofi, USB, Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Arno WR van Kuijk Grant/research support from: Janssen, Stefan Siebert Grant/research support from: BMS, Boehringer Ingelheim, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Boehringer Ingelheim, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Celgene, Janssen, Novartis, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Consultant of: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – consultant, Speakers bureau: Celgene Corporation, Eli Lilly, Novartis, Pfizer, UCB – speakers bureau and honoraria, Elisa Gremese Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Sanofi, UCB, Roche, Pfizer, Beatriz Joven-Ibáñez Speakers bureau: Abbvie, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Wim Noel Employee of: Janssen Pharmaceuticals NV, Petros Sfikakis Grant/research support from: Grant/research support from Abvie, Novartis, MSD, Actelion, Amgen, Pfizer, Janssen Pharmaceutical, UCB, Elke Theander Employee of: Janssen-Cilag Sweden AB, Josef S. Smolen Grant/research support from: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Consultant of: AbbVie, AstraZeneca, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, ILTOO, Janssen, Novartis-Sandoz, Pfizer Inc, Samsung, Sanofi, Laure Gossec Grant/research support from: Lilly, Mylan, Pfizer, Sandoz, Consultant of: AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB

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POS0407 PROTEOMICS ANALYSIS COMPARING THE MODE OF ACTION OF UPADACITINIB BETWEEN NON-BIOLOGIC-DMARD-IR AND BIOLOGIC-DMARD-IR PsA PATIENTS IDENTIFIES DISTINCT PATHOGENIC PATHWAYS IN THE SELECT-PsA 1 AND SELECT-PsA 2 PHASE 3 STUDIES

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.1652 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 433.1-433

Author(s):

T. Sornasse ◽

J. Anderson ◽

K. Kato ◽

A. Lertratanakul ◽

I. McInnes ◽

...

Keyword(s):

Disease Activity ◽

Clinical Response ◽

Rheumatic Diseases ◽

Inadequate Response ◽

Protein Biomarkers ◽

Research Support ◽

Positive Correlation ◽

Disease Biology ◽

Biologic Dmard ◽

Favorable Clinical Response

Background:Treatment of non-biologic-DMARD-IR1 (DMARD-IR) and biologic-DMARD-IR2 (bio-IR) PsA patients with upadacitinib (UPA) at 15 mg QD, an oral JAK1 selective inhibitor, resulted in significant improvement in signs and symptoms compared to placebo.Objectives:Using a pre-defined set of inflammation-related plasma protein biomarkers (pBM), to explore immunological pathway modulation by UPA 15 mg QD in PsA patients with active disease despite treatment with non-biologic or biologic DMARDs in the context of clinical response vs. non-response to treatment.Methods:Patients from the SELECT-PsA 1 (DMARD-IR) and the SELECT-PsA 2 (bio-IR) studies were randomly selected (PBO, n=100; UPA 15 mg QD, n=100 for each study). The levels of 92 inflammation related protein biomarkers (pBM) were analyzed using a multiplexed Proximity Extension Assay platform in plasma samples collected at baseline, week 2, and 12; change from baseline in protein levels was expressed as Log2 Fold Change; a Repeated Measure Mixed Linear Model was used to identify pBM modulated by UPA compared to Baseline, and those differentially modulated between responders (R) and non-responders (NR) according to ACR50, PASDAS Minimal Disease Activity, and PASI75 at week 12. Correlation of disease activity measures with relative levels of pBM were derived using Pearson’s correlation; PASI score was transformed as Log10 (x+1) prior to the analysis. Functional pathway prediction was performed in silico with a commercial distributed software.Results:At baseline, the relative levels of 37 pBM correlated with at least one baseline disease activity measure, with a marked positive correlation of IL6 with musculoskeletal end points (PASDAS and DAS28CRP), and a strong positive correlation of IL20, IL17A, IL17C, and TGFA with baseline PASI.At the single pBM-level, treatment with UPA 15 mg QD resulted in a down modulation of pBM associated with T cells, myeloid cells, and IFN-, IL6-, and TNF-related pathways in both DMARD-IR and bio-IR PsA patients. Overall effects of UPA on single pBMs were broadly similar between DMARD-IR and bio-IR patients. However, analysis of pBMs differentially modulated by UPA in R vs NR indicated that favorable clinical response (achievement of ACR50, PASDAS MDA, and PASI75) in DMARD-IR patients was associated with the down modulation of pBMs predicted to be linked to IFN, IL10, IL17, IL22, and IL27 pathways; while favorable clinical response in bio-IR patients was associated with the down modulation of multiple pBM predicted to be linked to the IL17, IL23, and IL1 pathways.Conclusion:UPA effects in both DMARD-IR and bio-IR PsA patients likely stem from the direct and indirect inhibition of multiple biological pathways belonging to the adaptive and innate immune systems. Responder/Non-Responder analysis suggests a possible shift from a TH1 biased biology in DMARD-IR PsA patients to a more TH17 biased biology in bio-IR PsA patients. This apparent change in the disease biology of PsA patients after inadequate response to prior therapy could be attributed to the actual alteration of the disease biology, treatment outcome-based patient selection, or both. Considering the clinical efficacy of UPA in both DMARD-IR and bio-IR PsA patients, this observation highlights the importance of targeting multiple pathways with drugs such as UPA for the treatment of a broad range of PsA patients.References:[1]McInnes, I. et al. Annals of the Rheumatic Diseases 79, 16-17 (2020).[2]Mease, P.J. et al.Annals of the Rheumatic Diseases, annrheumdis-2020-218870 (2020).Acknowledgements:AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.Disclosure of Interests:Thierry Sornasse Shareholder of: AbbVie, Employee of: AbbVie, Jaclyn Anderson Shareholder of: AbbVie, Employee of: AbbVie, Koji Kato Shareholder of: AbbVie, Employee of: AbbVie, Apinya Lertratanakul Shareholder of: AbbVie, Employee of: AbbVie, Iain McInnes Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, UCB Pharma, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sanofi Regeneron, UCB Pharma, Christopher T. Ritchlin Consultant of: AbbVie, Amgen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB Pharma, Grant/research support from: AbbVie, Amgen, UCB

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POS1021 THE PsABio STUDY IN ITALY: A REAL-WORLD COMPARISON OF THE PERSISTENCE, EFFECTIVENESS AND SAFETY OF USTEKINUMAB AND TUMOUR NECROSIS FACTOR INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.81 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 778-779

Author(s):

E. Gremese ◽

F. Ciccia ◽

C. Selmi ◽

G. Cuomo ◽

R. Foti ◽

...

Keyword(s):

Adverse Event ◽

Psoriatic Arthritis ◽

Disease Activity ◽

Tumour Necrosis Factor ◽

Tumour Necrosis ◽

Research Support ◽

Treatment Persistence ◽

Low Disease Activity ◽

Necrosis Factor

Background:There are still unmet needs in the treatment of psoriatic arthritis (PsA), including in terms of treatment persistence, which is a function of effectiveness, safety and patient satisfaction. Ustekinumab (UST) was the first new biologic drug to be developed for the treatment of PsA after tumour necrosis factor inhibitors (TNFi).Objectives:To compare treatment persistence, effectiveness and safety of UST and TNFi in Italian patients within the PsABio cohort.Methods:PsABio (NCT02627768) is an observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. The current analysis set includes 222 eligible patients treated in 15 Italian centres, followed to Month 12 (±3 months). Treatment persistence/risk of stopping was analysed using Kaplan−Meier (KM) and Cox regression analysis. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation of effectiveness endpoints if treatment was stopped/switched before 1 year. Last observation carried forward data are reported.Results:Of patients starting UST and TNFi, 75/101 (74.3%) and 77/121 (63.6%), respectively, persisted with treatment at 1 year. The observed mean persistence was 410 days for UST and 363 days for TNFi. KM curves and PS-adjusted hazard ratios confirmed significantly higher persistence (hazard ratio [95% confidence interval (CI)]) for UST versus TNFi overall (0.46 [0.26; 0.82]; Figure 1). Persistence was also higher for UST than TNFi in patients receiving monotherapy without methotrexate (0.31 [0.15; 0.63]), in females (0.41 [0.20; 0.83]), and in patients with body mass index (BMI) <25 kg/m2 (0.34 [0.14; 0.87]) or >30 kg/m2 (0.19 [0.06; 0.54]). There was no significant difference in persistence between treatments in patients with BMI 25−30 kg/m2. While patients receiving 1st- and 3rd-line UST or TNFi showed similar risk of discontinuation (0.60 [0.27; 1.29] and 0.36 [0.10; 1.25], respectively), patients receiving 2nd-line UST showed better persistence than those receiving 2nd-line TNFi (0.33 [0.13; 0.87]). Other factors added to the PS-adjusted Cox model did not show significant effects. In patients with available follow-up data, the mean (standard deviation) baseline cDAPSA was 26.3 (15.4) for UST and 23.5 (12.3) for TNFi; at 1-year follow-up, 43.5% of UST- and 43.6% of TNFi-treated patients reached cDAPSA LDA/remission. MDA was reached in 24.2% of UST- and 28.0% of TNFi-treated patients, and VLDA in 12.5% of UST- and 10.2% of TNFi-treated patients. After PS adjustment (stoppers/switchers as non-responders), odds ratios (95% CI) at 1 year did not differ significantly between UST and TNFi groups for reaching cDAPSA LDA/remission (1.08 [0.54; 2.15]), MDA (0.96 [0.45; 2.05]) or VLDA (0.98 [0.35; 2.76]). In total, 23 (20.4%) patients reported ≥1 treatment emergent adverse event with UST and 30 (22.2%) with TNFi; 6 (5.3%) and 10 (7.4%) patients, respectively, discontinued treatment because of an adverse event.Conclusion:In the Italian PsABio cohort, UST had better overall persistence compared with TNFi, as well as in specific subgroups: females, patients on monotherapy without methotrexate, with BMI <25 or >30 kg/m2, and patients receiving UST as 2nd-line treatment. At 1 year, both treatments showed similar effectiveness, as measured by cDAPSA responses and MDA/VLDA achievement.Acknowledgements:This study was funded by Janssen. Contributing author: Prof. Piercarlo Sarzi-Puttini, ASST Fatebenefratelli-Sacco, University of Milan, ItalyDisclosure of Interests:Elisa Gremese: None declared, Francesco Ciccia Speakers bureau: AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Consultant of: Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Grant/research support from: Celgene, Janssen, Novartis, Pfizer, Roche, Carlo Selmi Speakers bureau: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Consultant of: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, Giovanna CUOMO: None declared, Rosario Foti Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Actelion, Biogen, Janssen, Lilly, Consultant of: Chemomab, Grant/research support from: MSD, Fabrizio Conti Consultant of: AbbVie, Bristol-Myers Squibb, Galapagos, Lilly, Pfizer, Enrico Fusaro Speakers bureau: AbbVie, Amgen, Lilly, Grant/research support from: AbbVie, Pfizer, Giuliana Guggino Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, Sandoz, Grant/research support from: Celgene, Pfizer, Florenzo Iannone Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Andrea Delle Sedie: None declared, Roberto Perricone: None declared, Luca Idolazzi Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Sandoz, Paolo Moscato: None declared, Elke Theander Employee of: Janssen, Wim Noel Employee of: Janssen, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Silvia Marelli Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche.

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Analyses of Gait and Jump Tasks in Female Obese Adolescents

Pediatric Exercise Science ◽

10.1123/pes.24.1.26 ◽

2012 ◽

Vol 24 (1) ◽

pp. 26-33 ◽

Cited By ~ 3

Author(s):

Filipe Ricardo Pires de Carvalho ◽

Ana Teresa da Conceição Figueira Martins ◽

Ana Maria Miranda Botelho Teixeira

Keyword(s):

Lower Extremity ◽

Fat Mass ◽

Normal Weight ◽

Female Adolescents ◽

Electromyographic Activity ◽

Countermovement Jump ◽

Weight Group ◽

Normal Weight Group ◽

Additional Load ◽

Task Differences

In spite of the advances in knowledge on the multi–factorial nature of obesity, many questions related to the consequences of the disease continue to be unanswered. Several studies have reported biomechanic and kinematic adaptation and alterations in walking and in tasks of every day life, motivated by the additional load of fat mass in children and adults. The main objective of this study was to understand the effect of obesity in the electromyographic activity of four lower extremity muscles during three speeds of walking and during a countermovement jump (CMJ) in twenty two (9 obese and 13 normal weight) female adolescents aged 13. Although electromyographic differences were not observed between groups for normal, slow and fast speeds, data suggests that the preferred pace of the obese is less efficient than that of the normal weight group. In CMJ task, differences in the after–fall jump phase were observed. More studies are needed to explain if the few differences observed between groups are caused by the bigger amount of fat mass.

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