Academic literature on the topic 'Biological therapy (BT)'

Background:Women with inflammatory arthropaties have fertility problems and complications during pregnancy and frequently biological therapy (BT) is required for the disease control.Objectives:To evaluate pregnancy in women with inflammatory arthropaties in a multidisciplinary unit composed of Rheumatologists and Obstetricians: describe disease evolution, complications and treatment used (including BT).Methods:Retrospective and descriptive study of the evolution of pregnancy in patients withinflammatory diseases (Rheumatoid Arthritis (RA), Spondyloarthritis (SpA) and Juvenile Idiopathic Arthritis (JIA)) and follow-up in a multidisciplinary unit for more than 15 years (until December 2020). Demographics, maternal disease, time until conception, previous abortions and presence of antibodies were collected. In addition, during follow-up, treatment, abortions, Caesarean sections (C-section), preterm births, disease activity and maternal/fetal complications were collected.Results:We registered 41 pregnancies (32 women): 20 RA (62.5%), 9 SpA (28.1%) and 3 JIA (9.4%). Maternal average age at diagnosis was 27.1±6.6 years and average age at childbirth/abortion was 34.9±5.1 years.It took an average time of 9.6±8.5 months to conceive. 9.8% received fertility treatment with in vitro fertilization techniques.AntiRo antibodies were registered in 7.3% of patients and 34.1% had at least 1 antiphospholipid antibody.At the time of gestational desire/gestation 17 women (12 RA, 4 SpA, 2 JIA) were receiving BT: 7 certolizumab (CZP), 7 adalimumab (ADA), 3 etanercept (ETN). 1 patient was being treated with baricitinib. Due to pregnancy, ADA was changed to CZP in 3 women and BT was stopped in 6 cases (3 ETN, 2 ADA, 1 CZP) as well as baricitinib. In 2 cases, ADA was stopped at week 17 of pregnancy (medical indication). Pregnancy was completed with BT (CZP) in 9 cases.9 abortions were registered prior to follow-up in the unit (0.28 abortions/mother) and 3 during follow-up (0.09 abortions/mother): 2 of them in women with CZP.C-section was performed in 26.8% of cases.Preterm birth (<37 weeks) happened in 9.7% (n: 4) of the pregnancies: 1 case in a woman with CZP.A total of 17 different fetal/maternal complications were registered during follow-up: 6 in the BT group (35.3%) compared to 11 (64.7%) in the group without BT, being Intrauterine Growth Restriction (IUGR) more frequent among women with BT. Infections were not more common in patients with BT. Complications are listed in Table 1.Table 1.COMPLICATIONSWITH BT (n, %) n: 11WITHOUT BT (n, %) n: 30IUGR3 (27.3%)1 (3.3%)LOW BIRTH WEIGHT2 (18.2%)2 (6.6%)INFECTION1 (9.1%)4 (13.3%)CHOLESTASIS0 (0%)2 (6.6%)PREECLAMPSIA0 (0%)1 (3.3%)DIABETES MELLITUS0 (0%)1 (3.3%)HIGH BLOOD PRESSURE0 (0%)0 (0%)NEPHROPATY0 (0%)0 (0%)NEONATAL LUPUS0 (0%)0 (0%)HEART BLOCK (0%)0 (0%)MALFORMATION0 (0%)0 (0%)HELLP SYNDROME0/0%)0 (0%)TOTAL6 (54.6%)11 (36.4%)Regarding concomitant treatment, low dose prednisone was used in 48.8% of pregnancies, hydroxychloroquine in 51.2%, sulfasalazine in 9.8% and acetylsalicylic acid in 51.2%. We didn´t find differences in the use of these treatments between the two groups.Median DAS28 among RA patients and available data was under 2.6 throughout pregnancy as well as previously and posteriorly. No differences in median DAS28 were found between women with BT and without BT. SpA patients had BASDAI lower than 4 in both groups during pregnancy and previously.Conclusion:In our series, as described in the literature, women with inflammatory arthropaties are older and are more likely to have preterm births compared to general population. Fewer abortions were registered during follow-up in the multidisciplinary unit. Appropriate disease control was maintained during pregnancy, also previously and afterwards. We registered more IUGR and low birth weight among women with BT but given the low number of patients with BT no statistically significant conclusions about complications can be drawn. Therefore, more studies among pregnant women with BT are necessary.Disclosure of Interests:None declared

Background:Rheumatoid arthritis (RA) associated lung disease is a relatively frequent extra articular disease manifestation, with a prevalence between 5% and 30%. The rather wide range of estimated prevalence is a result of differences in study designs and studied populations, as well as lacking diagnostic and classification criteria for lung disease in patients with RA.Objectives:To evaluate the prevalence of RA associated lung disease in patients with biological therapy (BT), as well as its severity, treatment changes and possible associated factors.Methods:Review of clinical records of 257 patients with RA treated with BT (TNFi, non-TNFi) between January 2015 to December 2020 in a single center. Patients with preexisting lung disease for other causes (asthma, smoking) have been excluded. RA diagnosis was performed according to ACR 2010 classification criteria. Epidemiological variables, clinical characteristics, type of pulmonary involvement, evolution, type of BT, changes in treatment and concomitant treatment were collected. For the analysis frequencies and percentages are used in qualitative variables, and mean ± SD in the quantitative ones. Statistical analysis was performed with IBM SPSS v 23.Results:We registered 21 patients (85.7% women) mean aged 70.3±11.9 years. 52.4% were never smokers. RF was positive in 100% and 20 patients were anti-CCP positive. Erosive disease was present in 13 (61.9%) patients.At the time of lung disease diagnosis, 15 patients (66.7%) were receiving TNFi (Etanercept 7, Adalimumab 6, Infliximab 1, Golimumab 1), 2 were with non-TNFi (Rituximab) and 4 had never received BT previously. Symptoms (cough and/or dyspnea) were reported in 10 (47.6%) patients. The median time of treatment with BT until lung disease diagnosis was 33 [15.5-95.5] months. Conventional synthetic DMARDs (csDMARDs) were used in 85.7% of cases (methotrexate 72.2%, leflunomide 22.2%, other 5.6%). The inflammatory activity was mild (DAS28: 3.22±1.6). The median time until lung disease diagnosis was 104 [56.2-156] months.After the lung disease diagnosis, BT was only modified in 1 patient. In the 4 patients who had not previously received BT, non-TNFi was started (Rituximab 2, Abatacept 1, Tocilizumab 1). csDMARD was discontinued in 1 patient.Interstitial lung disease (ILD) was the most frequent pulmonary involvement (16 patients, 76.2%): 8 usual interstitial pneumonia (UIP), 6 non-specific interstitial pneumonia (NSIP), 1 organising pneumonia (OP) and 1 lymphocytic interstitial pneumonia (LIP). Other pulmonary manifestations observed in our patients were: nodular lung disease (2 patients) and small airways disease (bronchiectasis 2, obliterative bronchiolitis 1). Chest x-ray was normal in almost half of the patients (42.9%). Gold standard image diagnostic technique was high resolution CT.In respiratory function tests (PFTs) at diagnosis, only 4 patients (19%) had a FVC<80% and 4 (19%) a DLCO<60%. In the following 2 years, in 2 patients the FVC worsened > 10% and in 5 there was a worsening of the DLCO > 15%. In 3 (14.3%) patients PFTs were never performed and in 7 (43.7%) were not repeated after the diagnosis.We haven´t found association between different types of pulmonary involvement and the variables analysed.Conclusion:In our series, prevalence of RA associated lung disease is similar to that described in the literature. Lung involvement is asymptomatic and chest X-ray is normal in most RA patients. High resolution CT is the gold standard for diagnosis.ILD was the most frequent pulmonary involvement. Although in most patients the diagnosis of lung disease did not imply a BT change, it had an influence on the type of BT chosen for those who started treatment. Maintenance of csDMARD was not associated with a worsening of lung disease.Screening and treatment protocols for lung disease in patients with RA in clinical practice are needed.Disclosure of Interests:None declared

Background:Objectives:. To describe the percentage of spondyloarthritis patients on biological therapy (BT) optimization in clinical practice whowould maintain remission or low disease activity (LDA) after 2 years of follow-up and to identify possible factors associated with relapse. To estimate the cost reduction between 2009-19Methods:Design:A retrospective, observational longitudinal study under conditions of clinical practice.Patients:Spondyloarthritis in BT dose reduction. Inclusion criteria: Psoriatic arthritis (CASPAR criteria), and Axial Spondyloarthritis (ASAS criteria) which have been iniciated BT dose reduction between 2009-2019. Patients with BT are followed prospectively by two rheumatologists in a monographic clinic of subcutaneous biological therapy every 6 months, and with their usual rheumatologist every 6 months, as well. In such, the patients are controlled and attended in clinics with a pre-established questionnaire every 3 months.Variables:Maintained Reduction:patients who maintained BT dose reduction since de beginning of the optimization until the index date(data collection).Relapse at 3,6,12,24 months: patient who had to returnt to usual BT dose. Other variables: demographic, time to diagnosis and evolution disease, clinical-analytical: Tender Joint Count(TJC), Swollen Joint Count (SJC), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), activity index: DAPSA; BASDAI, ASDAS and physical function: HAQ and BASFI. Previous treatment with bDMARD. Dose reduction adjustment according to REDOSER. Cost reduction in euros(absolute and per patient-year) of BT in patients who are in dose reduction compared to the standard care. Analysis: Descriptive, Bivariate analysis, Multivariate logistic regression (DV:relapse). The absolute cost reduction and per patient-year was calculated.Results:65 patients with spondyloarthritis in dose reduction were included. Table 1 main characteristics in study population. The average time since the beginning of the BT was 47.61 months (±37.06). After 24 months of follow-up, 73.8% of patients (48) achieved a sustained reduction. All these patients accomplish remission or low disease according to differente index activities [DAPSA and BASDAI median(p25-p75)= 2.3 (2.1- 2.9) and 1.5 (0.7- 2.6), respectively and ASDAS mean (SD) =1.4 (0.54)] and a shorter time of disease evolution. The dose reduction of BT carried out from 2009 to 2019 meant a total cost savings of 584080.37€, with a patient/year cost savings of 6192.28€. We evaluated the optimization according to REDOSER and it was observed that in 53 patients (81.5%) the reduction would have been adequate and the rest was doubtful. In bivariant analysis between patients who had relapsed and those who had not, only differences were observed in the BT line used [2nd line:(5(29.4%) Vs 2(4.2%),(p=0.025)] and and a higher percentage of patients with a doubt result of REDOSER [9(52.9%)Vs 3(6.3%), p<0.001)] respectively. In multivariant analysis the only independent variable associated with relapse was a doutbful result of REDOSER[OR(IC95%), 3.46(1.18-10.17); p=0.024], R2= 40.2%Figure 1:Conclusion:Biological therapy dose reduction in spondyloarthritis is possible in the majority of patients, maintaining remission/LDA at 24 months. This leads to a greater cost reduction and efficiency. The relapse was associated with a doubtful result in REDOSER before optimization and this tool can be very useful in the assessment of BT reduction.Disclosure of Interests:None declared

Abstract Introduction. Efficacy of biological treatment (BT) is a key issue among inflammatory bowel disease (IBD) patients. Laboratory markers and endoscopic procedures are basic diagnostic tools in the assessment of response to biological agents in the course of Crohn’s disease (CD) and ulcerative colitis (UC). Aim. The aim of our investigation was to assess the correlation between laboratory parameters and endoscopic picture in the course of BT in patients with IBD – CD and UC–treated with biological agents. Material and methods. The total number of 71 patients were enrolled in the study, 25 with CD and 46 with UC. When it comes to 15 patients with CD, they were treated with infliximab (IFX) and 10 patients with adalimumab (ADA) – one year of therapy. Patients with UC were administered IFX – induction therapy. Laboratory tests (C-reactive protein (CRP) and platelet (PLT) count) and colonoscopy were performed in all patients before and during BT. Results. BT improved endoscopic picture (SES-CD, MAYO) in all patients. BT lowered CRP (p<0.05) and PLT count (p<0.05) in CD group. CRP level and PLT count decreased in UC group, too (p<0.05). A positive correlation between PLT count and SESCD score prior to the first dose was noticed in ADA group. CRP level correlated positively with PLT count in CD patients treated with IFX before the introduction of BT. Moreover, CRP level correlated positively with both MAYO score and MAYO endoscopic subscore after the second dose of IFX and after finished induction regimen in UC group. Discussion. BT revolutionized a natural history of IBD and its efficacy was approved worldwide. Nevertheless, biological agents do not lead to a full remission of the disease in all patients. Because of this reason, laboratory parameters and endoscopic picture must be carefully monitored during BT to achieve the best outcome in IBD patients. Conclusion. Full clinical and endoscopic remission of IBD was not achieved, although BT lowered CRP level, PLT count and improved endoscopic picture of patients enrolled into our study.

Background:Objectives:To describe the characteristics of patients with rheumatoid arthritis (RA) in dose reduction of biological therapy (BT) in clinical practice and identify possible factors associated with the time in dose reduction and verify the utility of REDOSER tool.Methods:Design:A retrospective, observational longitudinal study under conditions of clinical practice.Patients:RA in BT dose reduction between 2007- 2019 were selected. Inclusion criteria: RA according to ACR 2010 criteria which have been initiated BT dose reduction. Patients with BT are followed prospectively every 3-4 months in a specialized outpatient unit of BT dose reduction with a pre-established protocol for data collection and registered in a database.Variables: Primary:Time in reduction: was defined as the time in which patients maintained the BT optimization andRelapse at 12 and 24 months: percentage of patients who, after starting BT optimization, return to the previous or standard dose.Secondary variables:REDOSER:Appropriate, Doubtful and Inappropriate (If dose reduction was adequate according to the REDOSER tool applied retrospectively were evaluated). Other variables: Demographic, clinical-analytical: time of disease evolution, RF, anti CCP antibodies, Number of Tender Joints, Number of swollen joints, erosions, activity index (DAS28, SDAI, CDAI) and physical function (HAQ). Previous treatments.Statistical Analysis:descriptive, bivariate using x2 and T-Student among patients with and without relapse at 24 months and multivariate linear regression to identify independent variables associated with the time in BT dose reduction (DV: time in reduction).Results:59 patients with RA were included. Table 1 shows the main characteristics of the subjects. The average (SD) of optimization in months was 17.9 (17.7). Ten patients (16.9%) relapsed at 12 months and 16 (27.1%) at 24 months. The mean (SD) of DAS28 and SDAI of patients who relapsed at 24 months was higher compared to baseline DAS28 (2.3 [0.9] vs. 1.5 [0.8]; p = 0.015) and SDAI (7.8 [6.3] versus 3.3 [1.6]; p 0.05). These patients who relapsed at 24 months compared to patients who did not have more erosions at the start of BT (p = 0.004), longer duration of disease (p = 0.072) and greater baseline activity of DAS28 (p = 0.017), of SDAI (p = 0.030) and CDAI (p = 0.036). After simulating the REDOSER tool to all patients at the beginning of the OBT, 28 patients (56%) were “Appropriate”, 20 (40%) “Doubtful” and 2 (4%) “Inappropriate” of which they continue in OBT at the conclusion of study 22, 10 and 0, respectively (p = 0.020). In the multivariant analysis, the independent variables that are associated with time in dose reduction of BT were baseline DAS28 (β = -0.660, 95% CI[2.7-14.0]; p=0.014) and age (β=-0.800, 95% CI [0.8-0.0]; p=0.038).Conclusion:The majority of the patients with RA who initiate BT dose reduction maintain the optimization after 24 months. REDOSER can be useful in clinical practice to assess the BT optimization in patients with RA. A longer time in BT dose reduction was associated with lower values of DAS28 at the beginning and younger age of the patients.Figure 1:Disclosure of Interests:None declared

Background:Therapeutic decision-making for biologic-therapies/ synthetic FAME (BT/SD) dose optimization, should be based on optimal disease activity results according to a treatment strategy by objectives. The goal of BT optimization is to guarantee long-term effectiveness and safety, maximising economic savingsObjectives:To evaluate BT optimization patterns in patients with rheumatic diseases (RD) and associated economic savings.Methods:An observational and prospective study, which included a cohort of patients with rheumatoid arthritis (RA), spondyloarthropathies (SA) and psoriatic arthritis (PsA) treated with BT from January 2014 to December 2019. BT optimization, achieved by reducing or prolonging the interval at least one dose, was indicated when patients have more than 6 months of treatment and are in clinical remission (DAS28 <2.6 for RA and PsA, and BASDAI<2 for SA) or minimal clinical activity (DAS28<3.2 for RA and PsA, and BASDAI<4 for SA).Variables were described as frequencies and means. Diagnosis, BT (abatacept, adalimumab, apremilast, baricitinib, certolizumab, etanercept, golimumab, ixekizumab, secukinumab, tocilizumab, tofacitinib, and ustekinumab), dose regimens, total treatment duration, time on BT optimization (TO) and treatment costs were collected.Cost savings were calculated per patient by comparing optimization treatment costs to conventional treatment and globally by comparing real cost to theoretical conventional doses cost.Results:A total of 260 patients were included in the study. Switching were observed in 32.7%. From all patients, 53% were candidates for BT optimization (according to diagnosis: 60.9% with RA, followed by 52.2% with SA and 43.4% with PsA)A 40% of patients with BT optimization were treated with adalimumab and etanercept being also the most common BT used in RD treatmentBT optimization allowed a pharmaceutical saving of€ 177,539.40per year against the use of conventional therapy, resulting in a reduction of the total cost of€1,065,236.40in the last 6 years. The saving per patient / year was € 707.63 for RA; € 850,40 for SA and of €493,21 for the PsA.Conclusion:Therapeutic decision-making based on validated disease activity scales has allowed the BT optimization in approximately 53% of patients with RD.BT optimization allowed a pharmaceutical saving of € 177,539.40 per year being higher in the SA (€ 850.40) followed by the RA (€ 707.63) and finally the PsA (€ 493.21)The BT optimization allows to reduce costs maintaining the effectiveness and safety.Disclosure of Interests:None declared

AbstractBotulinum toxin (BT) has been successfully used for many years to treat various muscle hyperactivity disorders including dystonia and spasticity. Its dosing is guided by dosing tables describing target muscles and dose ranges. To refine the BT dosing, we wanted to analyse how contextual factors may influence the injector's final dosing decision.In a retrospective review of real-life data of 1170 BT treatments, we studied the influence of various contextual factors on the BT doses in 21 arm muscles of 252 patients receiving BT therapy for different muscle hyperactivity disorders.We found that BT arm doses are significantly higher in treatment of spasticity than in treatment of dystonia. We also found that spontaneous arm dystonia requires higher BT doses in a proximal application pattern, whereas task specific writer's cramp requires considerably reduced BT doses with a distal application pattern. Injections of non-arm muscles influence the BT dosing in arm muscles only marginally.Our study demonstrates that BT dosing does not only depend on the particularities of the individual target muscle injected, such as its volume and its static or phasic function. BT dosing and its application pattern rather depend on additional contextual factors such as the aetiology and pathophysiology of the muscle hyperactivity treated. These contextual factors need to be included in dosing tables and may improve the outcome of BT therapy.

AbstractBotulinum toxin (BT) therapy is a complex and highly individualised therapy defined by treatment algorithms and injection schemes describing its target muscles and their dosing. Various consensus guidelines have tried to standardise and to improve BT therapy. We wanted to update and improve consensus guidelines by: (1) Acknowledging recent advances of treatment algorithms. (2) Basing dosing tables on statistical analyses of real-life treatment data of 1831 BT injections in 36 different target muscles in 420 dystonia patients and 1593 BT injections in 31 different target muscles in 240 spasticity patients. (3) Providing more detailed dosing data including typical doses, dose variabilities, and dosing limits. (4) Including total doses and target muscle selections for typical clinical entities thus adapting dosing to different aetiologies and pathophysiologies. (5) In addition, providing a brief and concise review of the clinical entity treated together with general principles of its BT therapy. For this, we collaborated with IAB—Interdisciplinary Working Group for Movement Disorders which invited an international panel of experts for the support.

Spondyloarthritides (SpAs) is a group of chronic inflammatory diseases of the spine, joints, and entheses characterized by common clinical, radiological, and genetic features. According to international guidelines, one of the main goals of SpA treatment is to ensure the longest possible preservation of the patient's quality of life (QOL). The use of biological agents (BAs) allows rapid clinical improvement and positively affects QOL in patients.Objective: to evaluate the efficacy of BAs on QOL in patients with SpA in real clinical practice.Patients and methods. A total of 280 patients with SpA were examined. The inclusion criteria were ≥18 years of age; compliance of the clinical picture of the disease with the ASAS criteria for axial SpA (2009) or peripheral SpA (2011); and signing the informed consent form. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS); the functional status of the patients was estimated by the Bath Ankylosing Spondylitis Functional Index (BASFI), and their spinal mobility was evaluated by the Bath Ankylosing Spondylitis Metrology Index (BASMI); ASAS HI was used to comprehensively evaluate the impact of SpA on the patient's health. The European QL EQ-5D-5L and the SF-36 questionnaire were applied to determine quality of life in the patients.Results and discussion. The patients' mean age was 40.19±11.9 years; there was a male preponderance (64%); the HLA-B7-pisitive patients were 78%. The median scores were 5.40 [3.12; 6.80] for BASDAI, 3.37 [2.58; 4.15] for ASDAS, 5.30 [2.60; 7.50] for BASFI, 4.00 [2.60; 6.15] for BASMI, and 9.00 [7.00; 12.00] for ASAS HI. Forty-four patients received a variety of BAs. Patients receiving and not receiving BAs were matched for age and gender; however, the patients on biological therapy (BT) had longer disease duration and lower disease activity according to the ASDAS. There were no statistically significantly difference between the two groups in disease activity according to the BASDAI and in functional disorders according to the BASFI; but there was a tendency towards lower values in the patients on BT. Comparison of QOL in the patients of the two groups revealed statistically significant differences in SF-36 pain scale scores (p=0.02) and EQ-5D-5L indicators (p<0.01).Conclusion. BT makes it possible to successfully achieve one of the main goals of treating patients with SpA, namely to preserve QOL. The patients receiving BAs had longer disease duration, while they were comparable to those not receiving this treatment in terms of the degree of functional disorders.

Background:Uveitis is the most frequent extraarticular manifestation of axial Spondyloarthritis (axSpA). Effects of Biological Therapy (BT) on uveitis associated to axSpA are contradictory (1-3).Objectives:To assess in uveitis associated to axSpA a) frequency and features of uveitis, and b) efficacy and relation of BT in a single-center university study.Methods:Observational study from a cohort of 301 consecutive unselected patients with axSpA classified according to the Assessment of SpondyloArthritis International Society criteria. Episodes of uveitis were analyzed before and after BT initiation. Likewise, uveitis incidence rate (episodes/100 patients/year) at baseline and after first BT was calculated.Results:Uveitis was observed in 44 (25 men/19 women) out of 301 (14.6%) patients. Mean age was 45.6 ± 10.3 years. Demographic and clinical features in patients who developed uveitis and those that did not are summarized in Table 1. After 18.6 ± 10.4 years of follow-up, 44 (14.6%) patients suffered from at least one episode of uveitis. Uveitis was anterior and acute in all cases and unilateral in 37 (84.1%) patients. Mean anterior chamber cells was 1.7 ± 1.2 cells.Per episode of uveitis, 20 patients received BT with: secukinumab (SECU) (n=7, 35%), adalimumab (n=6, 30%), golimumab (n=3, 15%), infliximab (n=2, 10%), certolizumab (n=1, 5%), and etarnecept (ETN) (n=1, 5%). Before the initiation of BT, patients treated with SECU developed 29.7 episodes/100 patients/year while those treated with monoclonal anti-TNFα 16.3 episodes/100 patients/year and patients with ETN 5.8 episodes/100 patients/year. After 5.9 ± 3.7 years of follow-up, patients treated with SECU developed 16.1 episodes/100 patients/year while those treated with monoclonal anti-TNFα 7.6 episodes/100 patients/year and patients with ETN 0 episodes/100 patients/year (Figure 1). No serious adverse effects were observed.Conclusion:Uveitis was observed in 14.6% of axSpA. Most of them were HLA-B27 positive. Acute, anterior and unilateral was the most frequent pattern of uveitis in axSpA. There was a similar decrease in incidence rate between patients treated with SECU and those treated with monoclonal anti-TNFα.References:[1]Deodhar AA, et al. ACR Open Rheumatol. 2020; 2:294-299.[2]Roche D, et al [abstract]. Arthritis Rheumatol 2019; 71 (suppl 10).[3]Lindström U, et al Annals of the Rheumatic Diseases 2020;79:9-10.Table 1.Main general features and differences between patients with and without uveitis.Overalln= 301Uveitisn= 44Non uveitisn= 257pAge, years (mean±SD)44.9 ± 11.845.6 ± 10.344.8 ± 12.10.47Gender, n (m/w) (%)179/122 (59.5/40.5)25/19 (56.8/43.2)154/103 (59.9/40.1)0.71HLAB27 positive,n (%)190 (63.1)37 (84.1)153 (60.0)0.00Follow-up of axSpA, year (mean±SD)13.5 ± 11.218.6 ± 10.512.6 ± 11.10.33Family history, n (%)84 (27.9)15 (34.1)69 (27.2)0.35r-axSpA, n (%)217 (72.1)36 (81.8)181 (70.4)0.12nr-axSpA, n (%)84 (27.9)8 (18.2)76 (29.6)0.12Enthesitis, n (%)108 (35.9)14 (31.8)94 (36.6)0.54Peripheral arthritis, n (%)96 (31.9)12 (27.3)84 (32.7)0.47Psoriasis, n (%)35 (11.6)6 (13.6)29 (11.3)0.65Inflammatory bowel disease, n (%)22 (7.3)2 (4.5)20 (7.8)0.45Hip involvement, n (%)20 (6.6)3 (6.8)17 (6.6)0.96Dactylitis, n (%)17 (5.7)3 (6.8)14 (5.4)0.72Cardiovascular event, n (%)7 (2.3)1 (2.3)6 (2.3)0.98Figure 1.Uveitis incidence rate before and after biological therapy.Disclosure of Interests:Alba Herrero-Morant: None declared, Iñigo González-Mazón: None declared, Vanesa Calvo-Río Speakers bureau: Abbott, Lilly, Celgene, Grünenthal, UCB Pharma, Grant/research support from: MSD and Roche, Javier Rueda-Gotor: None declared, Miguel Á. González-Gay Speakers bureau: AbbVie, Pfizer, Roche, Sanofi, Lilly, Celgene and MSD, Grant/research support from: AbbVie, MSD, Jansen and Roche, Ricardo Blanco Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Sanofi, Lilly and MSD, Grant/research support from: AbbVie, MSD and Roche

GMOs. Genetically modified organisms. They conjure the specter of “Frankenfoods.” Monstrous creations reflecting human hubris. Violations of nature. And their very unnaturalness alone seems reason to reject the whole technology. But one may challenge this sacred bovine: the common image that GMOs cross some new threshold, dramatically changing how humans relate to nature. Or even that such a view can properly inform how we assess the value or risks of GMOs. Rather, biologically, GMOs are modest variants. As I will elaborate, “conventional” corn is probably more deeply shaped by human intervention than any addition of, say, a single Bt gene for a pesticide-resistant protein. Many crops promoted as “natural” alternatives are themselves dramatically modified genetically, like the cats and dogs we enjoy as pets. And this perspective—the context of GMOs—should inform views on policy. Without resolving the question of ultimate risks, we should at least recognize and dismiss as irrelevant the claim that GMOs are “unnatural.” While criticisms of GMOs vary, one recurrent theme is the assertion—or the implicit assumption—that they are inherently unnatural. For example, one high school student commented in a class discussion on genetically modified salmon, “Even though it definitely has many economic benefits, I think that shaping the way in which other organisms grow and live is not something that we as humans should be taking into our own hands.” As rendered recently for young readers, a cartoon princess of the Guardian Princess Alliance scolds a grower of GMOs: “These fruits and vegetables are not natural.” Many seem to believe that for humans to alter something living is to thereby taint it. Organisms should remain “pure.” Nature seems to exhibit its own self-justified purpose, not to be disrupted. What does this mean for all the other ways that humans modify organisms from their “natural” state? For example, we adorn our skin with tattoos and pierce various body parts. In certain cultures, at certain times, we have bound feet and elongated skulls.