Non-biologic Group Research Articles

P173 The positive utility of PSAID-12 score in remote monitoring and the impact of gender and treatment on patient reported outcomes in psoriatic arthritis

Abstract Background/Aims Psoriatic arthritis (PsA) is a chronic inflammatory disease that significantly impacts the quality of life (QOL) of patients. The PSAID-12 score reflects the impact of the PsA from the perspective of the patients. This study assessed patient reported outcomes using the PSAID-12 and evaluated the impact of gender, treatment and disease duration. Methods This study was a cross-sectional, observational study of patients with PsA meeting CASPAR critieria. Patients were recruited consecutively from clinic and completed the PSAID-12 questionnaires 14 days prior to their clinic visit digitally or by paper. Demographic and clinical data, including age, gender, disease duration, medication were collected. Disease activity was measured using the the tender/swollen joint count, patient/physician assessment and CRP. Results The total number of patients in the study was n = 225. The female:male ratio was 1.0:0.8. The mean disease duration was 27 years (range 2 months to 44 years). The mean age was 52 years (range 18 to 86 years). The number of patients on DMARDs was 89.3 % (201/225) and combined DMARDs and biologics was 26.67 % (60/ 225). The mean PSAID-12 score was 4.09 (SD 2.47). There was a positive correlation between the pre-clinic PSAID-12 score and the in-person calculated tender joint count (r = 0.58), swollen joint count (r = 0.51) and the Likert pain score (r = 0.84). All domains of the PsAID-12 score were higher in female than male (4.53 vs 3.47 respectively), Table 1. Fatigue, discomfort, and pain were the most reported score for females (mean 5.52, 5.22, 5.02 respectively) whereas for males the commonest scores were discomfort, pain and fatigue (mean 4.10, 3.88, 3.88 respectively). The fourth commonest score for both genders was the impact on work and or leisure activities (4.67 for females and 3.83 for males). In terms of disease duration, discomfort is the most common reported score for patients with a disease duration of less than 5 years (mean 5.09) whereas fatigue was the most common complaint in patients with the group of 5-10 years and >10 years (4.56 and 5.11 respectively). There was a lower mean score of skin problems in the biologics compared to the non-biologic group (2.78 vs 3.90). There was a trend towards lower coping, embarrassment, and social participation scores in the biologics group. Conclusion The PSAID-12 score correlated well with PsA disease activity. The impact on QOL from PsA was higher in females than males. Fatigue, pain and discomfort were the commonest symptoms and higher scores were reported in early disease, with discomfort being the highest in this group. Fatigue was more commonly reported in patients with longer disease duration. The benefits of the biologics on QOL and skin problems were seen in these patients despite their longer disease duration. Disclosure A. Chan: None. N. Soe: None.

Asthma Inflammatory Phenotypes: How Can We Distinguish Them?

induced sputum is used to assess different inflammatory phenotypes in asthma, but is not used routinely. We aimed to determine the proportion of inflammatory asthma phenotypes based on induced sputum, to find biomarkers that can discriminate between phenotypes, and to evaluate biomarkers in patients with and without biological therapy in different inflammatory asthma phenotypes. this cross-sectional study investigated clinical characteristics, asthma control tests, skin prick test, impulse oscillometry (IOS), spirometry, induced sputum, biomarkers (IgE, eosinophils, fractional exhaled nitric oxide (FeNO), serum periostin, IL-5, IL-6, IL-8, IL-17A, IL-33) in 80 asthmatics. A total of 17/80 patients were treated with biologics (10 with omalizumab, 7 with benralizumab). a total of 31% of patients had eosinophilic asthma (EA), 30% had mixed granulocytic asthma (MGA), 24% had paucigranulocytic asthma (PGA), and 15% had neutrophilic asthma (NA). The difference was found in blood eosinophils (p = 0.002), the highest observed in EA. The cut-off ≥ 240/μL eosinophils, with 64% sensitivity and 72.7% specificity, identified EA (AUC = 0.743, p = 0.001). A higher IL-8 level was associated with NA (p = 0.025). In 63 non-biologic asthma group, eosinophils were higher in EA than in NA, MGA, and PGA (p = 0.012, p = 0.028, and p = 0.049, respectively). A higher IL-17A was associated with EA without biologics (p = 0.004). A significantly higher IL-5 was found in EA treated with biologics, in comparison with EA without biologics (p = 0.043). The number of leucocytes and neutrophils was higher in MGA without biologics (p = 0.049, p = 0.019), while IL-5, IL-6, and IL-8 levels were higher in MGA treated with biologics (p = 0.012, p = 0.032, p = 0.038, respectively). EA and MGA were the most prevalent asthma phenotypes. Blood eosinophils can identify EA, both in patients with and without biologics. Apart from the clinical profile, a broad spectrum of biomarkers for assessing inflammatory phenotypes is necessary for an adequate therapy approach to patients with asthma.

The economic burden and quality of life of patients with psoriasis treated with biologics in China

BackgroundAlthough biologics improve the quality of life of psoriasis patients, they also impose a substantial economic burden. There is a lack of research addressing the economic and humanistic impact of biologics in China.ObjectiveThis cross-sectional investigation aims to assess the economic cost, quality of life, and patient satisfaction among individuals with psoriasis treated with biologics and non-biologics.MethodsFrom July 2021 to December 2022, eligible patients with psoriasis were recruited through both on-site and online questionnaire completion. The questionnaires collected sociodemographic data, clinical characteristics of psoriasis, economic costs associated with treatment, and the Dermatological Life Quality Index (DLQI).Results481 patients with a mean age of 40.8 ± 13.4 years old were included and classified into a non-biologic (n = 195) and biologic (n = 286) treatment group. The direct medical cost for non-biologics patients was 7,249 CNY, accounting for 70.0% of the total cost, while biologics patients incurred 15,176 CNY, making up 94.3% of the total cost. The non-biologic group had higher costs related to hospitalization, self-purchase of drugs, and indirect costs than the biologic treatment group. Additionally, DLQI scores were higher in the non-biologic group.ConclusionPatients in the biologic group experienced a higher economic burden and better quality of life than those in the non-biologic group.

Single-center experience of COVID-19 vaccine in patients with inflammatory rheumatic disease: Real-life data

Background/Aim: Patients with rheumatic disease are at high risk of infection complications, and vaccines are essential to prevent these diseases. Moreover, biologic disease-modifying/targeted synthetic anti-rheumatic drugs (b/tsDMARDs) have been shown to reduce the immunogenicity of vaccines, although their effectiveness, side effects, and effects on disease activity are not yet clear. In this study, we aimed to investigate the incidence of post-vaccine side effects, disease exacerbation, and COVID-19 infection despite vaccination in patients with inflammatory rheumatic disease; the difference in vaccination effects between patients who received and did not receive b/tsDMARD treatments. Methods: Patients received b/tsDMARD (i.e., biologic group (BG)) (n = 194) who were admitted to the rheumatology outpatient clinic, were included in this study. All patients with inflammatory rheumatological disease, who did not receive b/tsDMARD (n = 185), but who applied to the rheumatology outpatient clinic during this time, were included in the non-biologic group (NG). Patients followed were included and evaluated cross-sectionally. Clinical and demographic characteristics, as well as type of COVID-19 vaccination, post-vaccine side effects, COVID-19 infection status before and after vaccination, and post-vaccine rheumatological disease exacerbation, were also evaluated. Results: In BG, 92.2% of patients were vaccinated, but for NG, 82.7% were vaccinated against COVID-19 patients with BG, 46.2% were vaccinated with CoronaVac vaccine alone, 51.4% with Pfizer/BioNTech BNT162b2 vaccine alone, and 37.4% with a combination of CoronaVac and BNT162b2 vaccines. In the NG, 53.8% of patients were vaccinated with CoronaVac vaccine alone, 48.6% with BNT162b2 vaccine alone, and 36.2% with a combination of CoronaVac and BNT162b2 vaccines. There was a significant difference between groups, according to vaccine types (P = 0.040), as this difference was due to a larger number of patients vaccinated with the CoronaVac + BNT162b2 combination for BG. Adverse effects were detected in 99 patients (55.9%) with BG and 95 patients (62.5%) with NG post-vaccination. There was no difference between BG and NG vaccines (CoronaVac, BNT162b2, or their combination) for adverse effects (P > 0.05 for all). The vaccine with the most common adverse events was BNT162b2, for both BG and NG. The most common side effect was arm pain, significantly higher in BG (P = 0.014). Fever and rash were more common for NG (P = 0.017). Disease exacerbation was not observed with BG, whereas it was detected in 5 (1%) patients for NG that was different (P = 0.021). SARS-COV-2 infection was also significantly less common for BG vs. NG (15.3% vs. 20.3%) (P = 0.017). Despite COVID-19 vaccinations, 56 patients with BG and 62 patients with NG had COVID-19 (P = 0.005). Conclusion: Standardized vaccination comparisons could not be achieved, as patients using b/tsDMARD were vaccinated for fewer COVID-19 infections. Additionally, COVID-19 vaccines are well-tolerated in patients with rheumatological disease, with vaccine-related disease activity at 1%, only seen in those not using b/tsDMARDs.

BIOLOGICAL THERAPY AND POST-OPERATIVE OUTCOMES IN CROHN’S DISEASE PATIENTS UNDERGOING REPEAT ILEOCOLIC RESECTION

Abstract OBJECTIVES To assess the surgical outcome in Crohn’s disease (CD) patients undergoing repeat ileocolic resection treated with biologic therapy prior to the surgical intervention. METHODS A retrospective analysis of a prospective database including all CD patients who underwent repeat ileocolic resection between 2011 and 2021 was conducted. Patients were divided into two groups: patients treated with biologic therapy prior to surgery and controls. Clinical, peri and post-operative data was extracted from medical records and analyzed. RESULTS Sixty three patients underwent repeat ileocolic resection for CD. Thirty-two patients (50.8%) were male and the mean age was 52 (range 23-82) years. The most common indication for repeat ileocolic resection was anastomotic stricture in 56 patients (88.9%). The mean time from the index ileocolic resection to the repeat surgery was 14.5 (range 1-53) years. Twenty-seven patients (42.8%) were treated with biologic therapy prior to repeat surgical intervention. No demographic differences were found between the biologic therapy group and the control group including patients’ gender (p=0.12), age (p=0.69), median American Society of Anesthesiologists (ASA) score (p=0.56) and body mass index (BMI) (p=0.17). In addition, no differences were found in mean time from the index ileocolic resection (p=0.69), indication for surgery (p=0.22) and pre-operative albumin (p=0.39). Thirty-eight patients (60.3%) underwent repeat ileocolic resection using a laparoscopic approach, with a mean operative time of 225 (range 121-386) minutes. In 19 patients (30.1%) a fistula was identified, while an abscess was seen and drained intra-operatively in 5 patients (7.9%). Overall, the post-operative complication rate was 44.5% (28 patients) and the mean length of stay was 5.7 days. Post-operative complications were found to be more common in the non-biologic therapy group compared to the biologic therapy group (55.6% vs 29.7%, respectively; p=0.04). Conversion rate from a laparoscopic to an open approach was slightly higher in the biologic therapy group compared to the biologic therapy group (40% vs 26.1%, respectively; p=0.36) although it did not amount to a statistical significance. Operative time (226 vs. 225 minutes; p=0.92), mean length of stay (5.1 vs. 6.1 days; p=0.18) and readmission rate (16.6% vs. 11.1%; p=0.72) were similar between the two groups. Multivariate analysis of risk factors for post-operative complications showed that only prior biologic treatment was correlated with a lower risk (HR -0.28, CI 95% -0.5596 to -0.01898; p = 0.03). CONCLUSION In our series, patients treated with biologic therapy for CD who underwent repeat ileocolic resection had fewer post-operative complications.

Early experience of COVID-19 vaccine-related adverse events among adolescents and young adults with rheumatic diseases: A single-center study.

Considering the concerns regarding the coronavirus disease-2019 (COVID-19) vaccine safety among pediatric patients with inflammatory rheumatic diseases (IRD) due to a lack of data, an urgent need for studies evaluating safety profiles of vaccines emerged. Among participants vaccinated by CoronaVac inactive SARS-CoV-2 or BNT162b2 messenger RNA (mRNA) COVID-19 (Pfizer-BioNTech) vaccine, healthy children under 18 and patients under 21 with an at least 1-year follow-up period in our department for a childhood-onset rheumatic disease were included into this cross-sectional study. Overall, 246 subjects (141 [57.3%] females) (biologic group: 43, non-biologic group: 180, healthy control group: 23) were eligible for the study. The median age was 15.34 (12.02-20.92) years. The most common adverse events were fatigue (n=68, 27.6%), headache (n=44, 17.9%), myalgia (n=38, 15.4%), arthralgia (n=38, 15.4%), and fever (n=35, 14.2%). Only 3 subjects (2 patients with familial Mediterranean fever, and one healthy child) were considered to experienced serious adverse events, since they required hospitalization. Local reactions were seen in 20 (8.13%), and 27 patients (12.1%) had disease flares within 1 month after the vaccines. Although it was significantly higher in those who received the BNT162b2 mRNA vaccine (P<.001), there was no significant relationship between adverse event frequency and age, gender, the existing diseases, ongoing treatment regimens and pre-vaccination COVID-19 histories. Although immunogenicity studies for efficacy of the vaccines and long-term follow-up studies for adverse events monitoring are required, our study indicates an acceptable safety profile of COVID-19 vaccines and encourages children with IRD to be vaccinated.

Exposure to biologic therapy and associated maternal and neonatal outcomes in pregnancies complicated by inflammatory bowel disease

There is growing evidence that biologic therapy is safe in pregnancies complicated by inflammatory bowel disease and that its use outweighs the risk of worsening disease activity, which is associated with adverse pregnancy outcomes. To our knowledge, there are limited data regarding the use of biologic therapy and the associated maternal adverse effects such as the risk of hypertensive outcomes, postoperative complications, and infectious risk. Our objective was to evaluate a variety of obstetrical complications including maternal infectious outcomes, hypertensive outcomes, other adverse maternal outcomes including postoperative complications, venous thromboembolism, and postpartum hemorrhage; we also evaluated the neonatal outcomes associated with biologic use in pregnancies affected by inflammatory bowel disease. This was a retrospective cohort study including patients with inflammatory bowel disease who were pregnant and delivered at our institution. The maternal demographics and the incidence of maternal and neonatal outcomes were compared among groups on the basis of biologic exposure using the chi-square or Fisher exact test for categorical variables and the t test or Mann-Whitney test for continuous variables. Multivariable logistic regression analysis was performed on composite outcomes adjusting for age, disease activity, maternal obesity, history of cesarean delivery, and history of corticosteroid use in pregnancy. The statistical significance was defined as P<.05. A total of 322 patients who were pregnant, had inflammatory bowel disease, and delivered at our institution from 2012 to 2019, were included for analysis. Of these, 112 (34%) were on biologics during pregnancy. The patients in the biologic group had significantly lower body mass indices than the patients in the nonbiologic group (median body mass index, 22.4 vs 24.0, respectively; P=.04), and they were less likely to be multiparous (41% vs 59%, respectively; P=.003). In addition, more patients in the biologic group were likely to have Crohn disease with previous inflammatory bowel disease surgery (33% vs 20%, respectively; P=.01); otherwise, the 2 groups had similar baseline characteristics. Maternal infectious and hypertensive outcomes occurred significantly more frequently in the biologic group than the nonexposed group (22% vs 7%; P=.0003 and 19% vs 8%; P=.003, respectively). This remained statistically significant in multivariable logistic regression models. Specifically, maternal infectious and hypertensive outcomes occurred significantly more frequently in the patients on a single-agent antitumor necrosis factor treatment than the patients on no inflammatory bowel disease medication (24% vs 6%; P=.002; 22% vs 6%; P=.004), which remained statistically significant in multivariable logistic regression models. There was no difference in the neonatal adverse outcomes between the 2 groups. Our data suggest an association between antepartum biologic use- specifically antitumor necrosis factor alpha therapy-and an increased risk of maternal infectious and hypertensive outcomes. This increased risk may be related to underlying disease activity and the same should be incorporated into a discussion with the patient. However, the discussion must be balanced with the important benefit of optimal disease control associated with biologic use in patients being treated for IBD.

Biologics modulate antinuclear antibodies, immunoglobulin E, and eosinophil counts in psoriasis patients.

Psoriasis is a chronic disease centered on tumor necrosis factor (TNF), interleukin (IL)-23, and IL-17 axis. While psoriasis patients benefit from biologics targeting TNF, IL-17s, and IL-23 nowadays, suppression of these molecules could modulate the balances of immune systems. However, the incidence of autoimmune disease and T-helper 2 reaction during biologic treatments for psoriasis patients is not well documented. We retrospectively examined antinuclear antibody (ANA), eosinophil counts, and immunoglobulin E (IgE) levels for psoriasis patients who underwent biologic treatments in our dermatology clinic from June 10, 2010 to January 29, 2020. A cumulative total of 199 biologic treatments were performed for a total of 128 psoriasis patients. Compared to the non-biologic group of 109 psoriasis patients who received non-biologic treatment, patients treated with infliximab showed more incidents of high ANA (14%, p=0.039) and high eosinophils (14%, p=0.021). The use of brodalumab increased incidents of high eosinophils (21%, p=0.005) but did not affect increase in ANA and IgE. The increase in high IgE level was observed significantly more during the use of risankizumab (15%, p=0.011). Methotrexate was the most frequently used concomitant systemic treatment, but methotrexate did not affect ANA, eosinophil counts, and IgE levels. Since the biologics for psoriasis treatment modulate the balance of T-helper cells, careful observation is required to detect unexpected changes of systemic immune conditions under biologic treatments.

Rapid Implementation of a Multidisciplinary COVID‐19 Cytokine Storm Syndrome Task Force

ObjectivePatients with coronavirus disease 2019 (COVID‐19) can progress to a state of unregulated inflammation called cytokine storm syndrome (CSS). We describe formation and operation of a COVID‐19 multidisciplinary consultation service that was allowed to individualize treatment for critically ill patients with COVID‐19 during the pandemic.MethodsInstitutional experts from different subspecialties formed a COVID‐19 CSS task force at Montefiore Medical Center, Bronx, NY. They agreed on a set of four clinical and six laboratory parameters that can help early identify COVID‐19 CSS. We describe the formation and implementation of the COVID‐19 task force. The case series description of the COVID‐19 CSS consultation cohort highlights consultation volume, baseline characteristics, clinical and laboratory parameters, and how biologic treatments were allocated to these patients.ResultsBetween April 4,2020, and May 7,2020, the COVID‐19 CSS task force was formed, consisting of adult and pediatric rheumatologists and allergy and immunology physicians. The task force evaluated a total of 288 patients, of whom 197 (68%) were male, the median (interquartile range [IQR]) age was 62 (51‐70) years, 122 (42%) were Hispanic, and 88 (31%) were Black or African American. The common presenting symptoms in all referred patients were dyspnea (85%) and diarrhea (80%). Thirty‐one patients who received biologic therapy were younger, with a median (IQR) age of 53 (32‐63) years, as opposed to 62.5 (52‐70) years in the nonbiologic group (P = 0.008). A higher proportion receiving biologics was in the critical care setting (26 [84%] vs 151 [59%]; P = 0.006).ConclusionTo the best of our knowledge, this is the first multidisciplinary collaborative effort to provide individualized patient recommendations for evaluation and treatment of patients with COVID‐19 who may have CSS. This working model helped to devise an approach that may have identified patients who were most likely to benefit from biologic therapy in the absence of evidence‐based guidelines.

Efficacy and Safety of Intra-articular Sacroiliac Glucocorticoid Injections in Ankylosing Spondylitis.

To assess the efficacy and safety of intra-articular sacroiliac glucocorticoid injection in ankylosing spondylitis (AS). Patients with AS undergoing fluoroscopy-guided intra-articular sacroiliac glucocorticoid injection were enrolled between 2012 and 2018. Efficacy was assessed by numeric pain rating scale, acute phase reactants, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index, and Ankylosing Spondylitis Disease Activity Score (ASDAS). Patients who started biologics within 3 months despite the intervention were compared with those not starting biologics, hence: the nonbiologic group. A total of 96 patients were treated, with a total of 107 injections. After intervention, there were significant decreases in numeric pain rating scale (7.8 ± 1.8 vs. 3.3 ± 2.2, p < 0.001) and acute phase reactants level (erythrocyte sedimentation rate [ESR] 23.0 mm/h [10.0-47.0 mm/h] vs. 13.0 mm/h [4.0-27.0 mm/h], p < 0.001; C-reactive protein [CRP] 1.0 mg/dL [0.2-2.7 mg/dL] vs. 0.2 mg/dL [0.2-0.9 mg/dL], p < 0.001). Disease activity scores also decreased for BASDAI (6.2 ± 1.8 vs. 4.5 ± 2.5, p = 0.001), Bath Ankylosing Spondylitis Functional Index (5.5 [4.1-7.0] vs. 1.8 [0.5-4.1], p = 0.001), ASDAS-CRP (2.9 ± 1.0 vs. 2.3 ± 1.3, p = 0.046), and ASDAS-ESR (3.7 ± 1.1 vs. 2.4 ± 1.3, p < 0.001). However, 12 patients (12.5%) started biologics within 3 months. These patients showed higher ESR (91.0 mm/h [IQR 21.0-113.0 mm/h] vs. 21.5 mm/h [IQR 9.5-43.0 mm/h], p = 0.010), CRP (8.0 mg/dL [IQR 1.11-17.1 mg/dL] vs. 0.8 mg/dL [IQR 0.2-1.8 mg/dL], p = 0.002), BASDAI (7.4 ± 1.2 vs. 5.9 ± 1.8, p = 0.027), and ASDAS-CRP (4.0 ± 0.5 vs. 2.8 ± 1.0, p = 0.004) than the nonbiologic group. There was no serious adverse event. Intra-articular sacroiliac glucocorticoid injection can be a safe and effective treatment option for active sacroiliitis in AS.

Risk factors, including different biologics, associated with depression and anxiety in patients with rheumatoid arthritis: a cross-sectional observational study.

To evaluate the associated factors of depression and anxiety in patients with rheumatoid arthritis (RA) and examine the effect of different biologics. This cross-sectional study was conducted in a regional hospital in southern Taiwan from August of 2017 to April of 2018. A total of 625 patients with RA were included. RA disease activity was measured with Disease Activity Score over 28 joints based on erythrocyte sedimentation rate (DAS28-ESR). Depression and anxiety were measured with Hospital Anxiety and Depression Scale (HADS). Based on HADS scores, 38 subjects (6.1%) and 15 subjects (2.4%) were classified as depression and anxiety, respectively. Increased disease activity of RA is noted in RA patients with depression or anxiety, and among the items of DAS28-ESR, only the two subjective components: tender joint count over 28 joints (TJC28) and patient's global assessment (PGA) were significantly different. Multiple logistic regression analysis indicated that depression was significantly associated with TJC28 (adjusted odds ratio [aOR] = 1.10, 95% confidence interval [CI] 1.05-1.14) and female (aOR = 5.43, 95% CI 1.25-23.52); and anxiety was associated with TJC 28 (aOR = 1.07, 95% CI 1.00-1.15) and PGA (aOR = 1.03, 95% CI 1.01-1.06). Secondary analysis found a significantly lower risk of depression (aOR = 0.20, 95% CI 0.04-0.88) in patients receiving etanercept, but not anxiety, when compared with the non-biologic group. This study suggests that only subjective components of DAS28-ESR were significantly associated with depression and anxiety. In comparison with other biologics, patients receiving etanercept appeared to have a lower risk of depression.Key Points• Rheumatoid arthritis patients possessed higher risk of depression and anxiety.• Both depression and anxiety are strongly correlated with the subjective components of DAS28-ESR.• Etanercept might be the choice of biologics in rheumatoid arthritis patients with depression.

Total Ankle Arthroplasty for Rheumatoid Arthritis

Category: Ankle Introduction/Purpose: Outcomes after total ankle arthroplasty (TAA) combined with additive techniques (1. augmentation of bone strength, 2. control of soft tissue balance, 3. adjustment of the loading axis) for rheumatoid arthritis (RA) cases were evaluated after mid to long-term follow-up. The influences of biologic treatment on the outcomes after TAA were also evaluated. Methods: We performed a retrospective observational study involving 50 ankles (44 patients) that underwent TAA for the treatment of rheumatoid arthritis. The mean duration of follow-up was 7.1 years. Clinical outcomes were evaluated with use of the Japanese Society for Surgery of the Foot (JSSF) scale score and a postoperative self-administered foot-evaluation questionnaire (SAFE-Q). Radiographic findings were evaluated as well. These parameters also were compared between patients managed with and without biologic treatment. Results: This procedure significantly improved the clinical scores of the JSSF rheumatoid arthritis foot and ankle scale (p &lt; 0.0001). Forty-eight of the 50 ankles had no revision TAA surgery. Subsidence of the talar component was seen in 8 ankles (6 in the biologic treatment group and 2 in the non-biologic treatment group); 2 of these ankles (both in the biologic treatment group) underwent revision TAA. The social functioning score of the SAFE-Q scale at the time of the latest follow-up was significantly higher in the biologic treatment group (p = 0.0079). The dosage of prednisolone (p = 0.0003), rate of usage of prednisolone (p = 0.0001), and disease-activity score (p &lt; 0.01) at the latest follow-up were all significantly lower in the biologic treatment group. Conclusion: TAA is recommended for RA cases, if disease control, augmentation of bone strength, control of soft tissue balance, and adjustment of loading axis are taken into account. The prevention of talar component subsidence remains a challenge in patients with the combination of subtalar fusion, rheumatoid arthritis, and higher social activity levels.

Developing and validating a simple and cost-effective strabismus surgery simulator

To demonstrate that a nonbiologic strabismus surgery simulator is not inferior to a biologic wet lab for teaching the key steps of strabismus surgery. A total of 41 medical students were randomly assigned to one of two groups: biologic wet lab or nonbiologic simulator. The students trained according to the group's protocol then participated in a recorded final assessment using a realistic strabismus surgery model. Two independent reviewers, masked to training method, graded the video recordings using three scoring systems: the International Council of Ophthalmology Approved-Ophthalmology Surgical Competency Assessment Rubric for Strabismus Surgery (ICO-OSCAR), the Global Rating Scale of Objective Structured Assessment of Technical Skills (OSATS), and the Alphabetic Summary Scale (ASS). The primary endpoint, total ICO-OSCAR score, was 36.7±2.2 for the wet lab group and 36.0±2.7 for the nonbiologic group (difference in means, -0.7; one-sided 95% CI, -2.0, ∞). The lower bound of the one-sided 95% confidence interval for the difference in mean scores was -2.0, which was greater than the a priori noninferiority margin of -5.0 points. The secondary outcome measure, mean total OSATS score and ASS score, revealed no statistical significant differences between training methods (P=0.73 and P=0.44, resp.). The simple, nonbiologic strabismus surgery simulator is not inferior to the biologic wet lab with respect to total ICO-OSCAR score. It is a portable, inexpensive, and effective training tool for novice surgeons.

Total Ankle Arthroplasty for Rheumatoid Arthritis in Japanese Patients: A Retrospective Study of Intermediate to Long-Term Follow-up.

Background:Outcomes after total ankle arthroplasty (TAA) combined with additive techniques (augmentation of bone strength, control of soft-tissue balance, adjustment of the loading axis) for the treatment of rheumatoid arthritis were evaluated after intermediate to long-term follow-up. The influences of biologic treatment on the outcomes after TAA were also evaluated.Methods:We performed a retrospective observational study involving 50 ankles (44 patients) that underwent TAA for the treatment of rheumatoid arthritis. The mean duration of follow-up was 7.1 years. Clinical outcomes were evaluated with use of the Japanese Society for Surgery of the Foot (JSSF) scale score and a postoperative self-administered foot-evaluation questionnaire (SAFE-Q). Radiographic findings were evaluated as well. These parameters also were compared between patients managed with and without biologic treatment.Results:This procedure significantly improved the clinical scores of the JSSF rheumatoid arthritis foot and ankle scale (p < 0.0001). Forty-eight of the 50 ankles had no revision TAA surgery. Subsidence of the talar component was seen in 8 ankles (6 in the biologic treatment group and 2 in the non-biologic treatment group); 2 of these ankles (both in the biologic treatment group) underwent revision TAA. The social functioning score of the SAFE-Q scale at the time of the latest follow-up was significantly higher in the biologic treatment group (p = 0.0079). The dosage of prednisolone (p = 0.0003), rate of usage of prednisolone (p = 0.0001), and disease-activity score (p < 0.01) at the time of the latest follow-up were all significantly lower in the biologic treatment group.Conclusions:TAA is recommended for the treatment of rheumatoid arthritis if disease control, augmentation of bone strength, control of soft-tissue balance, and adjustment of the loading axis are taken into account. The prevention of talar component subsidence remains a challenge in patients with the combination of subtalar fusion, rheumatoid arthritis, and higher social activity levels.Level of Evidence:Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Tu1321 Systematic Review With Meta-Analysis of Prospective Studies: Anti-TNFs for Prevention of Postoperative Crohn's Disease Recurrence

Background Although promising, the evidence supporting the use of anti-tumor necrosis factor agents (anti-TNFs) in the postoperative Crohn's disease (CD) is still based on limited experiences. Aim We aimed to conduct a meta-analysis of prospective studies evaluating the efficacy and safety of anti-TNFs for prevention of postoperative recurrence (POR) in CD. Methods MEDLINE, EMBASE, Web of Science, Cochrane database and conference proceeding abstracts were searched. The primary outcome measures were patients achieving remission or POR as defined by the primary studies and pooled. Results Six prospective studies were included. The rate of endoscopic recurrence (ER) was significantly lower in anti-TNFs (9.2%, 7/76) compared with non-biologic control group (61.5%, 83/135); odds ratio (OR) 0.05, 95% confidence interval(CI) 0.02-0.13; P<0.001). Severe ER also less frequently occurred in the anti-TNFs group (1.6%, 1/64) than the control group (32.7%, 18/55, OR 0.10; P=0.04). Significantly lower proportion of patients in the anti-TNFs group developed clinical recurrence (3.4%, 2/59) compared with the control arm (41.1%, 49/119; OR 0.1; P<0.001). More anti-TNFs-treated patients (86.5%, 45/52) maintained in clinical remission compared with the control group (58.1%, 43/74, OR 4.05; 95%CI 1.60-10.29, P <0.01). The documented adverse effects were comparable between the two groups (antiTNFs 44.9% (22/49) vs. control 52.5% (42/80), P =0.69). Conclusion Anti-TNFs are superior to non-biologic agents in preventing endoscopic and clinical recurrence of CD without causing more adverse effects.

Adverse effects of TNF inhibitors in SpA: are they different from RA?

Tumor necrosis factor (TNF) inhibitors were the first biologic drugs prescribed for the treatment of spondyloarthritis (SpA) and rheumatoid arthritis (RA). Although they provide significant improvement of signs and symptoms, TNF inhibitors need to be used frequently for a long period of time. The analysis of the follow-up of the largest national biologics registries has shown that the most important adverse effect of TNF inhibitors is infection, which is significantly higher than the non-biologic treatment group; reactivation of latent tuberculosis is three to four times more frequent in patients using monoclonal antibodies than soluble receptors. The only cancer site more frequent to be associated with TNF inhibitors in RA and SpA is the non-melanoma skin cancer. Paradoxical reactions do occur during anti-TNF treatment mainly in SpA, such as new manifestations or flares of acute uveitis, new onset of psoriasis, such as palmoplantar pustulosis, or new onset or flares of inflammatory bowel disease, which occurs especially during etanercept treatment.

AB0674 Axial Spondyloarthrits – What Target for Treatment?

BackgroundThe concept “treat to target (T2T)” is a guide to optimising treatment outcomes in rheumatoid arthritis. T2T is also advocated in axial spondyloarthritis (axSpA)1 but potential targets are unclear and...

FRI0184 Postoperative complications in rheumatoid arthritis patients receiving biologic and nonbiologic disease-modifying antirheumatic drugs

ObjectivesTo identify complications after total joint arthroplasty in rheumatoid arthritis (RA) patients (pts) treated with biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs).MethodsIn a retrospective 1:1 pair-matched case–control study 60 pts...

OP0146 Treatment with biologic agents improves the prognosis of patients with rheumatoid arthritis and amyloidosis

BackgroundReactive amyloid A (AA) amyloidosis is a serious and life-threatening systemic complication of rheumatoid arthritis (RA).Recently, therapy with biologic agents such as anti- tumor necrosis factor (TNF) and anti- interleukin...

Pain experience in children with juvenile idiopathic arthritis treated with anti-TNF agents compared to non-biologic standard treatment

BackgroundAnti-TNF agents have proven efficacy in children with severe juvenile idiopathic arthritis (JIA) who are unresponsive to standard therapy. Therefore pain reduction or elimination could be expected. The aim of this study was to compare the pain experience in children with JIA treated with anti-TNF agents (n = 41) or non-biologic standard treatment (n = 50).MethodsAll children completed a 2-week pain diary and, for children treated with anti-TNF agents, measures of pain-coping and pain-specific beliefs. Parents rated the child’s level of functional disability. Clinical data were collected from the pediatric rheumatologists.ResultsNo significant differences were found between the anti-TNF group and non-biologic standard treatment group for average pain score, number of children with daily pain reported in the pain diary, or level of functional disability. Significantly more children in the anti-TNF group reported no pain at all. Children undergoing standard treatment had significantly higher disease activity. Significant differences were found between the high pain patients treated with anti-TNF agents and the rest of the anti-TNF group in regards to their pain-specific beliefs of disability and harm, and the pain-coping strategy of catastrophizing.ConclusionThese results indicate that a great proportion of children treated with anti-TNF agents respond well to the treatment in regards to disease activity and pain, but pain was still a problem for a subgroup of children though they were in remission with biological agents. More focus on pain management is needed.