A. Villalba Yllan

Employment in a cohort of breast cancer patients

BACKGROUNDnBreast cancer survivors can have problems in returning to work. However, the importance of work to cancer survivors has until recently received little attention.nnnAIMSnTo investigate employment- and work-related disability in a cohort of breast cancer patients to identify possible discrimination and other obstacles to remaining in work.nnnMETHODSnQuestionnaire study of breast cancer patients employed at diagnosis and where diagnosis had been confirmed at least 6 months before the interview. Participants completed a questionnaire concerning cancer-related symptoms and work-related factors and clinical details were obtained from their medical records.nnnRESULTSnThe study included 96 consecutive patients with breast cancer aged between 18 and 65 years. In total, 80% of patients were unable to work after diagnosis, but 56% returned to work at the end of treatment. The sequelae of the disease or its treatment and the stage of disease were independently associated with the ability to work after the end of treatment. Only one patient did not tell his/her employers and coworkers about his/her disease. In total, 29% noticed changes in their relation with co-workers and managers, usually in the sense that they tried to be helpful. None reported job discrimination.nnnCONCLUSIONnBreast cancer survivors in this study encountered some problems in returning to work, mainly linked to the sequelae of their disease and its treatment rather than to discrimination by employers or colleagues.

SAT0331 Effect of Methotrexate on the Immnunogenicity of TNF Inhibitors in Spondyloartrhitis Patients

Background The spondyloarthritis (SpA) patients treated under TNF inhibitors (TNFi) with detectable antidrug antibodies (ADA) often develop loss of efficacy. Concomitant therapy with methotrexate (MTX) appears to reduce the the immunogenicity of biological drugs. Objectives To analyze if the use of combined therapy with MTX and TNFi can reduce the incidence of ADA and whether its effect is MTX dose dependent in SpA patients. Methods In this retrospective observational study, 162 SpA patients (including ankylosing spondylitis, Psoriatic SpA, SpA associated with inflammatory bowel disease and undifferentiated SpA) were included. The patients are treated with infliximab (Ifx) or adalimumab (Ada). The presence of ADA were measured at baseline and before each administration by ELISA to complete a follow up of 3 years. The patients were divided in two groups [MTX-15 (dose <15 mg/week) and MTX+15 (≥15 mg/week)] to study the influence of baseline MTX dose on immunogenicity. The statistical analysis was performed using SPSS 11.0. Results Eighty nine out of 162 (54,9%) patients were male. Eighty five out of 162 (52,5%) patients received Ifx and 77 out of 162 (47,5%) Ada. The mean duration of treatment was 13.38±9.19 years to Ifx and 12.71±10.46 years for Ada. Forty five patients received MTX weekly at baseline [25/85 (29.4%)in Ifx and 20/77 (26%)in Ada]. The mean dose of MTX was 15,9±4.76 mg/week. Twenty nine out of 162 (17,9%) patients developed ADA, and ADA presence was significantly higher in SpA patients on Ifx therapy [21/85 (24.7%) in Ifx vs 8/77 (10.4%) in Ada, p=0.018)]. The presence of ADA was less frequent in SpA patients taking MTX [3/162 (1.8%) with MTX vs 26/162 (16%) without MTX, p=0.021]. No statistically differences were observed in the influence of baseline MTX dose on the ADA appearance (in Ifx: 2/18 (11,1%) in MTX+15 vs 1/9 (11,1%)in MTX-15, p=1,0; in Ada: 1/17 (5,9%) in MTX+15 vs 0/4 (0,0%)in MTX-15, p=1,0). Conclusions In this cohort of SpA patients treated with Ifx and Ada, the use of MTX has a preventive effect on the ADA development. However, the baseline MTX dose is not a determinant factor to get this effect. Further prospective studies are needed to confirm these data. Disclosure of Interest A. Villalba Yllan: None declared, C. Plasencia Grant/research support: Pfizer, D. Pascual-Salcedo Grant/research support: Pfizer, Speakers bureau: Pfizer, D. Peiteado: None declared, L. Nuño: None declared, G. Bonilla: None declared, R. del Moral: None declared, A. Balsa Grant/research support: Pfizer, Speakers bureau: Pfizer, Roche, Abbvie, E. Martin Mola Speakers bureau: Pfizer, Roche, Abbvie, Amgen DOI 10.1136/annrheumdis-2014-eular.5819

SAT0157 Tocilizumab Serum Trough Levels Correlate with Clinical Activity in Rheumatoid Arthritis

Background Tocilizumab (TCZ), a humanized anti-IL-6 receptor antibody, represents a new treatment strategy for RA patients.Several studies have demonstrated the association between high serum levels of TNF-inhibitors and a good clinical response in patients with RA. Little evidence exists on this relationship for other biological therapies. Objectives To evaluate the association between TCZ serum through levels and disease activity in a cohort of RA patients after one year of treatment with TCZ. Methods 34 RA patients treated with Tocilizumab were included. Clinical activity was assessed using the Disease Activity Score 28 (DAS28-ESR) and the Clinical and Simplified Activity Index (CDAI and SDAI), serological improvement by C-Reactive Protein- CRP- and Erythrocyte Sedimentation Rate-ESR, clinical improvement by the delta-DAS 28 and response to treatment using EULAR criteria at baseline and after one year of treatment. We stratified all patients into quartiles according to the tocilizumab levels (μg/ml) as follows: IQR1: <3,4, IQR2: 3,4–11,2, IQR3: 11,2–18,5 and IQR4 >18.5. A last observation carried forward analysis (LOCF) was performed at the first year of treatment, so patients that dropped out of the therapy before this period were included. Blood samples were collected just before intravenous (i.v) infusion. Serum drug levels were determined by a capture enzymelinked immunosorbent assay (ELISA). Results The baseline demographic and clinical characteristics are shown in Table 1. When patients were categorised into quartiles, IQR1 comprised 8 (24,2%) patients; IQR2, 7 (21,2%); IQR3, 8 (24,2%) and IQR4, 10 (30,3%). Clinical activity (DAS28, CDAI and SDAI) was statistically significant higher in patients with lower serum through levels at the first year [DAS28 (IQR1: 4,46 ±1,5, IQR2: 2,58 ± 0,87, IQR 3: 3,6± 0,79; IQR4: 2,17 ± 0,74; p=0,001), CDAI (IQR1: 23±13,9, IQR2: 7,72 ± 4,44, QIR 3: 13,38± 4,35, IQR4: 6,33 ± 4,62; p=0,003) and SDAI (IQR1: 19,46 ±15,5, IQR2: 9,51± 7,4, IQR3: 12,59 ± 6,31, IQR4: 4,55 ± 3,73; p=0,005)] and also was the number of swollen joints (IQR1: 7,5 ± 6,6, IQR2: 2,29 ±2,06, IQR3: 5,63 ± 4,3, IQR4: 1,1 ± 1,6, p=0,013) and tender joints (IQR1: 5,5 ± 5,7, IQR2: 1,71 ± 2,06, IQR3: 3,13 ± 2,8, IQR4: 0,8 ± 0,9, p=0,014). In addition, the EULAR reponse was worse in those patients with lower serum drug levels [non-responders: 4 (66,7%) in IQR1 vs 1 (16,7%) in IQR2 vs 1 (16,7%) in IQ3 vs 0 (0%) in IQR4, moderate responders: 3 (37,5%) in IQR1 vs 0 (0%) in IQR2 vs 4 (50%) in IQR3 vs 1 (12,5%) in IQR4 and good responders: 1 (5,3%) in IQR1 vs 6 (31,6%) in IQR2 vs 3 (37,5%) in IQR3 vs 9 (47,4%) in IQR4, p=0,006]. In terms of acute-phase reactants, the mean ESR tended to be higher in patients with lower TCZ levels (IQR1: 22,6±14,8 vs IQR2: 5,6±1,6 vs IQR 3: 9,4 ±3,5 vs IQR4: 6,4 ± 3,5, p=0,005), and also CRP levels (RIQ1: 10,2±17,4 vs RIQ2: 2,3 ± 3,4 vs RIQ3 0,56 ± 0,4 vs RIQ 4: 0,42 ± 0,66, p=NS)]. Conclusions The presence of low serum Tocilizumab levels correlates with a worse clinical disease activity. Consequently, measurement of Tocilizumab levels is a valuable tool that might help in the clinical management of patients with Rheumatoid Arthritis. Disclosure of Interest C. Tornero Marín Grant/research support from: Funded by an unrestricted medical grant from Pfizer., C. Plasencia: None declared, D. Pascual Salcedo: None declared, T. Jurado: None declared, M. B. Paredes: None declared, I. Monjo: None declared, E. Moral: None declared, A. Pieren: None declared, G. Bonilla Hernán: None declared, D. Peiteado: None declared, P. Bogas: None declared, L. Nuño: None declared, A. Villalba Yllan: None declared, E. Martín Mola: None declared, A. Balsa Criado: None declared

FRI0169 Influence of Body Mass Index (BMI) on Serum Levels of Infliximab in Patients with Rheumatoid Arthritis (RA)

Background Loss of response of TNFα inhibitors (TNFi) over time resulting in discontinuing of this therapy is a major issue in RA, but underlying reasons for this remains unknown. A few studies suggest the influence of BMI on serum levels of subcutaneous TNFi. However, there is no available data on the possible influence of BMI on infliximab (IFX) serum levels, which is intravenously administred and adjusteing the dose according to patient weight. Objectives To determine the possible influence of BMI on serum IFX levels in patients with RA. Methods Retrospective observational study incluiding 72 patients with RA treated with infliximab, at 3 mg/kg dose in a standard regimen, in our department between 2000 and 2015. Serum IFX levels were determined by ELISA in 3 visits: i)2 weeks, ii)six months and iii)one year after treatment onset. BMI (kg/m2) was classified in four categories: underweight (<18,5), normal (≥18,5- <25), overweight (≥25- <30) and obesity (≥30). Descriptive analysis was used to compare drug levels between these four groups at each visit. To analyse the relationship between BMI and IFX drug levels, generalized estimation equation models adjusted for age, gender and concomitant treatment were employed. Results Characteristics of patients included in the study when initiating IFX therapy were: 88% female, median (range) age 52 (21–82) years, 71% RF+, 79% ACPA+, disease duration 10,4 (1,0–39,0) years, 79% with concomitant methotrexate and 57% with other DMARDs. Median (range) BMI was 25,5 (16,7–40,2) kg/m2. According to BMI, patients with underweight, normal, overweight and obesity were 2 (2,7%), 35 (48,6%), 23 (31,9%) and 12 (16,7%), respectively. Median (range) IFX serum levels, in ng/ml, for each of the four BMI categories,and for each of the visits, are presented in Table 1. At 2 weeks At 6 months At 1 year Underweight 34.977 (20.992–48.962) 7.500 (0–15.000) NA Normal 24.576 (2.944–150.000) 776 (0–12.800) 2.012 (0–14.336) Overweight 26.213 (768–50.000) 661 (0–3.456) 486 (0–9.416) Obesity 22.033 (9.891–34.816) 315 (0–5.344) 1.088 (0–3.904) In the longitudinal analysis, an inverse statistically significant relationship between BMI and drug serum levels was observed: β: -441,7; 95%CI (-829,7 to -53,8). This relationship remained despite of adjusting the model for potential confounders: β: -457,3; 95%CI (-858,8 to -55,8). Conclusions BMI influences serum IFX levels in patients with RA treated with infliximab. Higher BMI values are associated with lower serum drug levels. Acknowledgement Unrestricted grants from Pfizer Disclosure of Interest None declared

Protocolo diagnóstico y terapéutico del dolor de origen óseo en el paciente oncológico

Resumen La morbilidad osea es un problema que ocurre en muchos pacientes con cancer. Incluye dolor secundario a los tratamientos oncologicos y a la afectacion del hueso por la neoplasia, que en el 99% de los casos se debe a metastasis de otro origen, principalmente del pulmon, de la mama y de la prostata. Ademas del tratamiento del dolor propiamente dicho, los bifosfonatos son unos farmacos que se utilizan con frecuencia. Su accion se debe a una inhibicion de la actividad de los osteoclastos y pueden prevenir, reducir e, incluso, retrasar las complicaciones esqueleticas en pacientes en distintos estadios de la enfermedad.

Actividad laboral en una cohorte de pacientes con linfoma non Hodgkin

Background. Cancer affects many dimensions determining nquality of life, including work. However, the importance nof work to cancer survivors has received little nattention. nAim. Employment and work-related disability were ninvestigated in a cohort of non-Hodgkin´s lymphoma npatients to describe a possible discrimination and other nwork issues. nPatients and Methods. The study included consecutively n37 non-Hodgkin´s lymphoma patients who were nemployed at diagnosis. The questionnaire included cancerrelated nsymptoms and work-related factors. Clinical details nwere obtained from the medical record. Patients were ninterviewed face to face and 32 variables were recorded. nThe study was approved by the Ethical Committee of Hospital nLa Paz. All patients gave consent to participate. nResults. Eighty six per cent of patients were unable to nwork after diagnosis, but 68% returned to work at the end nof treatment. The type of worker and the sequelae of the ndisease or its treatment were independently associated with nthe ability to work after the end of treatment. Almost all npatients told their employers and co-workers about their ndisease. None reported job discrimination. nConclusions. This is the first exploratory study in nSpain about labour reintegration in non-Hodgkin´s lymphomas. nFurther studies are necessary