Biologic Exposure Research Articles

High rate of serious infection in juvenile idiopathic arthritis patients under biologic therapy in a real-life setting

Objectives: To assess the rate of serious and/or opportunistic infections in juvenile idiopathic arthritis (JIA) patients from a single tertiary center under biologic therapy and to identify possible risk factors associated to these complications.Methods: A total of 107 JIA patients followed at the biologic therapy center of our tertiary university hospital using a standardized electronic database protocol including demographic data, clinical and laboratorial findings and treatment at baseline and at the moment of infection. Opportunistic infections included tuberculosis, herpes zoster and systemic mycosis.Results: A total of 398 patient-yrs(py) were included. The median time of biologic exposure was 3.0 years (0.15–11.5). We observed 35 serious/opportunistic infectious events in 27 (25%) patients: 31(88.6%) were serious infections and four (11.4%) opportunistic infections. Serious/opportunistic infections rates were 10.6/100py for ETN, 10.9/100py for ADA, 2.6/100py for ABA and 14.8/100py for TCZ. Comparison of 27 patients with and 80 without infection showed a higher frequency of systemic-onset JIA, lower age at biologic therapy initiation and a history of previous serious infection (p < .05) in the former group.Conclusions: This study demonstrated a high rate of serious infections in JIA patients under biologic therapy in a real-life setting. Systemic-onset JIA, lower age at biologic therapy start and history of previous serious infections were important risk factors for these complications. Also, higher rates of severe infections comparing to the former studies was possibly due to elevated MTX doses in our patients.

Herpes zoster in psoriasis patients treated with tofacitinib

Tofacitinib is an oral Janus kinase (JAK) inhibitor. Immunomodulatory therapies can increase the risk for herpes zoster (HZ) in patients with psoriasis. To evaluate the relationship between tofacitinib use and HZ risk. We used phases 2 and 3 and long-term extension (LTE) data from the tofacitinib development program in psoriasis to calculate HZ incidence rates (IR; events per 100 patient-years); potential HZ risk factors were evaluated using Cox-proportional hazard models. One hundred thirty (3.6%) patients on tofacitinib (IR 2.55), no patients on placebo, and 2 using etanercept (IR 2.68) developed HZ. Nine patients (7%) were hospitalized, and 8 (6%) had multidermatomal HZ; no encephalitis, visceral involvement, or deaths occurred. In total, 121 (93%) patients on tofacitinib continued or resumed use after HZ. HZ risk factors included Asian descent (hazard ratio [HR] 2.92), using tofacitinib 10mg twice daily (vs 5mg twice daily; HR 1.72), prior use of biologics (HR 1.72), and older age (HR 1.30). Generalizability to other psoriasis populations might be limited. The effect of HZ vaccination was not studied. Tofacitinib is associated with increased HZ risk relative to placebo. Asian race, increasing age, higher dose, and prior biologic exposure are associated with heightened risk.

Generalizability of Patients With Rheumatoid Arthritis in Biologic Agent Clinical Trials.

Randomized controlled trials (RCTs) have consistently demonstrated the efficacy of biologic agents in treating patients with rheumatoid arthritis (RA) who satisfy strict eligibility criteria, yet studies report that a majority of RA patients in the US have had biologic treatment exposure. We identified the proportion of RA patients in clinical practice satisfying entry criteria for biologic agent RCTs. Eligibility criteria of 30 RCTs of 10 Food and Drug Administration-approved biologic agents to treat RA were reviewed, summarized, and applied to 2 observational clinical cohorts: the Veterans Affairs Rheumatoid Arthritis registry (VARA; n = 1,523) and the Rheumatology and Arthritis Investigational Network Database (RAIN-DB; n = 1,548). Patients at a single clinical encounter were assessed for overall trial eligibility as well as eligibility across 3 domains: demographics, disease activity, and medication exposure. The mean percentage of patients that satisfied eligibility criteria was 3.7% (interquartile range [IQR] 1.5-3.1) in VARA and 7.1% (IQR 4.4-7.7) in RAIN-DB. Ineligibility was most often due to low disease activity, specifically low joint counts. The mean Disease Activity Score in 28 joints at enrollment was 6.59 (range 6.1-7.1) across RCTs versus 3.87 (0.07-8.69) in VARA and 3.65 (0.49-7.21) in RAIN-DB. RCTs for non-tumor necrosis factor (TNF) inhibitor biologic agents were more restrictive than RCTs for TNF inhibitors. There was no trend in eligibility by RCT study publication or drug approval date. The vast majority of RA patients from our clinical cohorts did not satisfy criteria for participation in biologic agent RCTs. These findings underscore the need for caution in extrapolating trial results to day-to-day management of RA patients and may provide insight into the differential responses to biologic agents reported in prior observational studies.

Incidence of Gastrointestinal Perforations in Patients with Rheumatoid Arthritis Treated with Tocilizumab from Clinical Trial, Postmarketing, and Real-World Data Sources.

IntroductionThe aim of this study was to use multiple data sources to update information on gastrointestinal perforations (GIPs) during tocilizumab (TCZ) treatment in patients with rheumatoid arthritis (RA).MethodsReporting rates of GIP events were estimated from three distinct patient data sets: a TCZ-IV RA clinical trial all-exposure population, a global TCZ postmarketing safety database population, and a US healthcare claims database population of patients with RA, including patients who received TCZ, anti-tumor necrosis factor (aTNF) agents, or abatacept.ResultsThe clinical trial, global postmarketing, and healthcare claims populations provided 17,906, 382,621, and 3268 patient-years (PYs) of TCZ exposure, respectively. GIP incidence rates [95% confidence interval (CI)] were 1.9 (1.3–2.7), 1.2 (1.1–1.3), and 1.8 (0.7–4.0; specific definition) to 2.8 (1.3–5.2; sensitive definition) per 1000 PYs for the clinical trial, postmarketing, and healthcare claims populations, respectively. The GIP incidence rate (95% CI) for the comparator aTNF healthcare claims population ranged from 0.6 (0.3–1.2) to 0.9 (0.5–1.5) per 1000 PYs, for an absolute rate difference between TCZ and aTNFs of 1.2 (−0.3 to 2.5) to 1.9 (0.0–3.7) per 1000 PYs, corresponding to a number needed to harm between 533 and 828.ConclusionThe TCZ GIP event rates from multiple data sources were consistent with previously reported rates, did not increase over time, and were significantly associated with the number of prior biologics. Comparison of GIP incidence rates among patients with prior biologic exposure suggests that, for every 1000 patients treated with TCZ per year, an additional 1–2 GIP events might occur compared with patients treated with aTNFs.FundingRoche.

Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study.

IntroductionInterstitial lung disease (ILD) is a common extra-articular condition in rheumatoid arthritis (RA), but few studies have systematically investigated its incidence and risk factors in patients receiving anti-tumor necrosis factor-alpha (anti-TNFα) agents or alternate mechanisms of action (MOAs) (e.g., T-cell, B-cell, and interleukin-6 inhibitors).MethodsRA patients at least 18 years old were selected from the MarketScan databases (2010–2012) if they had at least one prescription/administration of abatacept, rituximab, tocilizumab, or anti-TNF after having discontinued a different biologic agent and meeting enrollment criteria. Cox models estimated the risk of incident ILD and ILD-related hospitalization. Sensitivity analyses used an alternate ILD case definition.ResultsWe identified 13,795 episodes of biologic exposure in 11,219 patients. Mean (standard deviation) follow-up was 0.7 (0.5) years. Patients receiving alternate MOA agents were more likely to have had recent exposure to steroids, prior exposure to a greater number of biologics, and history of ILD, anemia, chronic obstructive pulmonary disease, and other pulmonary conditions. When the sensitive definition was used, unadjusted ILD incidence rates (95 % confidence interval, or CI) ranged from 4.0 (1.6–8.2, abatacept) to 12.2 (5.6–23.2, infliximab) per 1000 person-years. Being older (hazard ratio (HR) 3.5; 95 % CI 2.1–6.0), being male (HR 3.1; 95 % CI 1.2–8.4), and having another pulmonary condition (HR 4.8; 95 % CI 1.7–13.7) were associated with increased ILD incidence in either sensitive and/or specific models. There were no significant differences by biologic class. Hospitalization rates (95 % CI) when the sensitive definition was used ranged from 55.6 (6.7–200.7, tocilizumab) to 262.5 (71.5–672.2, infliximab). In Cox models, recent methotrexate exposure was associated with reduced ILD hospitalization (HR 0.16; 95 % CI 0.06–0.46), whereas being male (HR 2.5; 95 % CI 1.3–4.8) and having had a hospitalization for asthma (HR 3.4; 95 % CI 1.2–9.8) or ILD/pneumonia (HR 2.3; 95 % CI 1.1–4.7) in the 12 months prior to index were associated with increased hospitalization risk.ConclusionsThere were no significant differences in the risk of ILD and its related complications between RA patients receiving anti-TNFα agents and those receiving alternate MOA agents. Further studies are needed that account for differences in baseline characteristics in order to fully evaluate the risk of ILD and its complications.

Malignancy risk in Australian rheumatoid arthritis patients treated with anti-tumour necrosis factor therapy: analysis of the Australian Rheumatology Association Database (ARAD) prospective cohort study.

BackgroundMalignancy risk with tumour necrosis factor inhibitor (TNFi) therapy remains unclear. Our primary aim was to assess malignancy risk with TNFi therapy in a cohort of Australian patients with rheumatoid arthritis (RA). We also assessed risk in a biologic-naïve group.MethodsDemographic data of all RA patients enrolled in the Australian Rheumatology Association Database before 25 October 2010 were matched to national cancer records in July 2010 (linkage complete to 2007). Verified self-reported malignancies occurring between 1 January 2008 and 25 October 2010 were also included in the analysis. Standardised incidence ratios (SIRs) were used to compare malignancy incidence in biologic-naïve and TNFi-exposed ARAD participants to the general population using site-, age- and sex-specific rates by calendar year. Rate ratios (RRs) were used to compare malignancy incidence in TNFi-exposed participants to biologic-naïve RA patients, and a composite RA cohort that included pre-TNFi person years, both adjusted for age, gender, smoking, methotrexate use and prior malignancy.ResultsForty-four malignancies were reported after 5752 person-years in the TNFi-exposed group (N = 2145) and 32 malignancies were reported after 1682 person-years in the biologic-naïve group (N = 803). No overall increased risk of malignancy in TNFi-treated RA patients was found when compared with the general population or with biologic-naïve RA patients. Compared to the biologic naïve group, without the inclusion of pre-TNFi years in the comparator group, the relative risk of female breast cancer was reduced in TNFi-treated patients (RR 0.17 (95 % CI 0.03 to 0.95)). It was no longer significant when adding pre-TNFi years in the comparator group. The risk of melanoma was increased for both biologic naïve and TNFi-treated patients when compared with the general population (SIR 2.72 (95 % CI 1.13 to 6.53) and SIR 2.03 (95 % CI 1.09 to 3.78) respectively). The relative risk of melanoma was not increased in the TNFi-exposed group compared with biologic naïve patients (RR 0.54, 95 % CI 0.12, 2.40). Inclusion of pre-TNFi person years in the comparator group did not change these results.ConclusionsMalignancy incidence was low in this RA cohort and biologic exposure did not increase the risk of malignancy. Melanoma risk was increased in both TNFi-treated and biologic-naïve RA patients compared with the general population suggesting that RA status, and possibly methotrexate exposure, may be responsible.

Acute Inhaled Xylene Poisoning Confirmed by Methylhippuric Acid Urine Test

Xylene is a commonly used toxic volatile organic solvent. Diagnosis of acute xylene poisoning is limited by the lack of a readily available analytic assay. Methylhippuric acid, a metabolite of xylene excreted in the urine, is used for biomonitoring occupational exposures to xylene. We report two cases of acute occupational poisoning from xylene inhalation suggested by determination of high urinary methylhippuric acid. Two 21 and 23 years old healthy male adults collapsed after inhaling an unknown paint thinner during painting. On admission to the emergency department, they were confused and agitated, without hemodynamic or respiratory impairment. Admission urinary methylhippuric acid determined by HPLC with UV detector were 2.57 and 2.68 g/g creatinine (Biologic Exposure Index, BEI, 1.5 g/g creatinine). Urinary hippuric acid was below the previously used BEI for toluene. Mild increases in alanine aminotransferase (80 U/L) and aspartate aminotransferase (71 U/L) were found 12 hours after exposure, returning to normal after 24 hours. The patients gradually regained full consciousness within 24 hours and discharged after 48 hours' observation without any sequelae. High urinary methylhippuric acid concentrations suggested the diagnosis of acute xylene poisoning following its inhalation. Diagnosis in previous reports of acute xylene poisonings relied on history and clinical manifestations. Urinary methylhippuric acid assay is specific and available in special laboratories. It is suggested to determine urinary methylhippuric acid together with metabolites of other widely available organic solvents (e.g., hippuric acid, trichloroacetic acid) whenever unintentional exposure or abuse of volatile organic compounds is suspected.

Radioembolization of hepatic tumors.

Unresectable primary and metastatic liver tumors are a leading cause of cancer mortality and morbidity. This remains a challenging and key task for every oncologist despite significant advances that have been made with selective targeted systemic agents and in technology advances with radiotherapy delivery. Radioembolization (RE) is a technique of permanently implanting microspheres containing Yttrium-90 ((90)Y), a beta-emitting isotope with a treatment range of 2 mm, into hepatic tumors. This form of brachytherapy utilizes the unique dual vascular anatomy of the liver to preferentially deliver radioactive particles via the hepatic artery to tumor, sparing normal liver parenchyma. The main treatment inclusion criteria are patients with solid tumors, compensated liver functions, life expectancy of at least three months, and ECOG performance status 0-2. Benefit of RE has been proven in patients that have low-to-moderate extrahepatic disease burden, prior liver radiotherapy, heavy prior chemotherapy and biologic agent exposure, and history of hepatic surgery or ablation. Most of the clinical evidence is reported in metastatic colorectal, and neuroendocrine tumors (NET), and primary hepatocellular cancer. A growing body of data supports the use of RE in hepatic metastatic breast cancer, intrahepatic cholangiocarinoma, and many other metastatic tumor types. Side effects are typically mild constitutional and GI issues limited to the first 7-14 days post treatment, with only 6% grade 3 toxicity reported in large series. Potentially serious or fatal radiation induced liver disease is extremely rare, reported in only 1% or fewer in major series of both metastatic and primary tumors treated with RE. Currently, high priority prospective clinical trials are testing RE combined with chemotherapy in first line therapy for colorectal hepatic metastases, and combined with sorafenib for hepatocellular carcinomas (HCCs). Fortunately, this beneficial and now widely available therapy is being increasingly incorporated into the standard therapy algorithms of multidisciplinary GI cancer teams worldwide. This form of radiotherapy differs significantly from daily external beam radiotherapy in many ways, particularly in dose rate, dosimetric coverage and duration of radiation delivery, side effects, and patient selection factors. A wealth of experience using RE in solid tumors exists and ongoing major prospective clinical trials will soon clarify the role of RE in the management of metastatic colorectal liver metastases.

AB0413 Hepatitis B Serologic Profile and Reactivation in Rheumatic Patients Treated with Biological Therapies – Single Centre Experience

BackgroundBiologic therapy for rheumatic diseases has been associated with increased risk of latent infections reactivation such as tuberculosis or hepatitis B (HB), due to severe immunosuppression. However, the actual risk...

Mo1184 Meta-Analysis of Thiopurine Exposure and Risk of Colonic Neoplasia in Inflammatory Bowel Disease

Background: Immunosuppressive medications play an important role in the management of inflammatory bowel disease (IBD). However, elderly patients are excluded from clinical trials and there is a paucity of data regarding the safety of immunosuppressive medications among elderly patients with IBD. The aim of this study was to examine the association between medication exposure and related complications and among elderly patients with IBD. Methods: We performed a cross sectional study of adults patients with IBD who received care at Baylor College of Medicine from July 2009 to June 2013. We identified IBD patients using ICD-9 codes for Crohn's disease (555.xx) and ulcerative colitis (556.xx). Demographic and clinical data were abstracted bymanual chart review using a standardized data abstraction form. Current and past medication exposure were classified as aminosalicylate/sulfasalazine, systemic steroids (prednisone/methylprednisolone), thiopurines (azathioprine, 6-mercaptopurine), methotrexate and biologics (infliximab, adalimumab, and certolizumab pegol). Potential medication-related complications were classified as infection, leukopenia, pancreatitis, hepatitis, osteoporosis/osteopenia, and cancer. The primary endpoint was association of medication exposure with the composite endpoint of any complication. Associations of medications with complications were assessed using univariate and multivariate logistic regression. Results: From a total of 1,525patients with IBD, we identified 144 patients who were 65 years or older at the time of data abstraction; mean age of 71.6 years (SD+6.1); 55% female; 38% with ulcerative colitis, 57% with Crohn's disease, and 5% with IBD unclassified. 32% of patients were observed to have at least one complication. In univariate analyses, thiopurine exposure was associated with an increased odds of any medicationrelated complication (OR 3.23 95% CI 1.53-6.80). On analysis of specific complications, thiopurine exposure was associated with higher rates on infection (OR 2.89 95% CI 1.087.76), but not other complications. None of the other examined medications, including biologics, were associated with medication-related complications. On multivariate analysis adjusting for gender, race, duration of disease and smoking, thiopurine exposure remained statistically significantly associated with the composite endpoint of any complication (OR 4.21 95%CI 1.84-9.65). Conclusions: One third of elderly patients with IBDwere observed to have a complication. Thiopurine exposure was associated with a 3-fold risk of complications compared to all other medication exposures. Biologic exposure was not associated with immediate medication-related complications. Thiopurine use in elderly patients with IBD requires close monitoring for infectious complications.

Mo1183 Prevalence of Serum JC Virus Antibody in Refractory Crohn's Disease Patients

Background: Immunosuppressive medications play an important role in the management of inflammatory bowel disease (IBD). However, elderly patients are excluded from clinical trials and there is a paucity of data regarding the safety of immunosuppressive medications among elderly patients with IBD. The aim of this study was to examine the association between medication exposure and related complications and among elderly patients with IBD. Methods: We performed a cross sectional study of adults patients with IBD who received care at Baylor College of Medicine from July 2009 to June 2013. We identified IBD patients using ICD-9 codes for Crohn's disease (555.xx) and ulcerative colitis (556.xx). Demographic and clinical data were abstracted bymanual chart review using a standardized data abstraction form. Current and past medication exposure were classified as aminosalicylate/sulfasalazine, systemic steroids (prednisone/methylprednisolone), thiopurines (azathioprine, 6-mercaptopurine), methotrexate and biologics (infliximab, adalimumab, and certolizumab pegol). Potential medication-related complications were classified as infection, leukopenia, pancreatitis, hepatitis, osteoporosis/osteopenia, and cancer. The primary endpoint was association of medication exposure with the composite endpoint of any complication. Associations of medications with complications were assessed using univariate and multivariate logistic regression. Results: From a total of 1,525patients with IBD, we identified 144 patients who were 65 years or older at the time of data abstraction; mean age of 71.6 years (SD+6.1); 55% female; 38% with ulcerative colitis, 57% with Crohn's disease, and 5% with IBD unclassified. 32% of patients were observed to have at least one complication. In univariate analyses, thiopurine exposure was associated with an increased odds of any medicationrelated complication (OR 3.23 95% CI 1.53-6.80). On analysis of specific complications, thiopurine exposure was associated with higher rates on infection (OR 2.89 95% CI 1.087.76), but not other complications. None of the other examined medications, including biologics, were associated with medication-related complications. On multivariate analysis adjusting for gender, race, duration of disease and smoking, thiopurine exposure remained statistically significantly associated with the composite endpoint of any complication (OR 4.21 95%CI 1.84-9.65). Conclusions: One third of elderly patients with IBDwere observed to have a complication. Thiopurine exposure was associated with a 3-fold risk of complications compared to all other medication exposures. Biologic exposure was not associated with immediate medication-related complications. Thiopurine use in elderly patients with IBD requires close monitoring for infectious complications.

Risk of hospitalised infection in rheumatoid arthritis patients receiving biologics following a previous infection while on treatment with anti-TNF therapy

BackgroundThe risk of subsequent infections in rheumatoid arthritis (RA) patients who receive biologic therapy after a serious infection is unclear.ObjectiveTo compare the subsequent risk of hospitalised infections associated with specific...

Assessment of Inflammation and Damage in Rheumatoid Arthritis Patients with Methotrexate Inadequate Response Receiving Tocilizumab Using Low Field MRI

Objectives: The aim of the study was to monitor joint inflammation and destruction in rheumatoid arthritis (RA) patients receiving tocilizumab therapy using MRI and compare MRI findings with clinical, biological and radiographic data. Methods: Inclusion criteria were patients aged between 18 and 65 years, fulfilling American College of Rheumatology 1987 criteria for RA. All patients had methotrexate inadequate response with no prior biologic exposure. All patients were evaluated clinically including disease activity score 28 (DAS28) and by low field dedicated MRI (dominant hand and wrist) at initiation of treatment with anti-IL 6 receptor antibody agents and after 6 months. The MRI images were scored using the Outcome Measures in Rheumatology Clinical Trials RAMRI score (OMERACT RAMRIS). Results: Among 22 patients with RA included in the study; 19 were female. The mean age was 42years ±13.7. Tree patients were excluded from the study before 24 weeks because of serious side effects. The study population exhibited significant decreases in all measures of disease activity at 24 weeks. At 24 weeks, the median RAMRIS synovitis (p<0.0001) and bone edema (p=0.04) scores were significantly reduced while RAMRIS bone erosion score was unchanged. The baseline RAMRIS synovitis score was strongly correlated with delta RAMRIS edema at 24 weeks (r= - 0.46; p=0.04). Conclusion: This study suggests a significant reduction in MRI pre-erosive lesions (synovitis and osteitis) using Tocilizumab in patients with RA with inadequate response to DMARDS. Prospective studies with long term follow-up and imaging as an outcome measure are needed.

Exposición ocupacional y ambiental al arsénico. Actualización bibliográfica para investigación científica

El arsénico (As) es un metaloide presente en minerales complejos que contienen cobre, plomo y otros; en el trabajador causa arsenicismo ocupacional y la principal exposición ocurre en metalurgia del cobre. Sus compuestos trivalentes tienen tendencia acumulativa e ingresan por las vías respiratoria, digestiva o cutánea y se transforman en los ácidos dimetilarsínico y metilarsónico. En la mitocondria, con el azufre de los grupos mercapto forma enlaces covalentes y desacopla la fosforilación oxidativa, sugiriendo una acción inhibitoria no hidrolítica a ese nivel. Es cancerígeno para varios órganos. Se excreta por orina, heces y piel. Los peces y mariscos contienen arsénico orgánico. En sujetos no expuestos, dependiendo de la dieta, el As inorgánico en orina es &amp;lt; 5 ug/L. El índice de exposición biológica para trabajadores medido al final de la semana laboral es 35 µg/g creatinina y el valor límite umbral para ambientes de trabajo es 0,01mg/m3. La arsina es el compuesto arsenical más tóxico. El arsénico contenido en el agua de ciertas regiones produce la enfermedad ambiental llamada hidroarsenicismo crónico regional endémico.

Development of a Postexposure Biologic Treatment Algorithm on a Medical Center Campus

To describe the development of an easily accessible online biologic exposure algorithm to guide postexposure medical evaluation and treatment of medical research personnel and health care workers in a Midwest medical center campus. We describe the steps involved in the creation of a biologic exposure algorithm from design through implementation. One point of contact allows phone evaluation and immediate triage, providing effective and timely medical care for exposed employees as well as important guidance for clinicians. The algorithm and exposure response system achieved the goal of integrating clinical and research laboratory exposure response. Development of an integrated clinical and research exposure protocol may be an efficient way to maximize biosafety for workers.

AB0288 Safety, effectiveness, work and household productivity of anti-tnf alpha therapy with certolizumab pegol observed in adult rheumatoid arthritis patients in daily practice in canada: first interim analysis of the non-interventional fast can study

BackgroundCertolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, has demonstrated a fast response and acceptable safety profile in rheumatoid arthritis (RA).ObjectivesTo evaluate the effectiveness and safety of CZP in daily clinical...

SAT0299 Apremilast: Pooled Safety Analysis of Three Phase 3, Randomized, Controlled Trials in patients with Psoriatic Arthritis

BackgroundApremilast (APR), an oral small molecule specific inhibitor of phosphodiesterase 4, works intracellularly to modulate inflammatory mediators. The PALACE 1, 2 and 3 trials compared APR efficacy and safety vs...

OP0103 Efficacy of Brodalumab, an Anti-IL-17R Antibody, in Subjects with Psoriatic Arthritis

BackgroundA potential role of IL-17 in the pathogenesis and ongoing inflammation of psoriatic disease, with similar pathways impacting skin and joint disease, suggests that cytokine-targeting strategies aimed at blocking signaling...

SAT0280 Efficacy of Apremilast, An Oral Phosphodiesterase 4 Inhibitor, on Physical Function and Pain in Patients with Psoriatic Arthritis, Including Current Skin Involvement: Results of a Phase 3, Randomized, Controlled Trial

BackgroundApremilast (APR), an oral phosphodiesterase 4 inhibitor, works intracellularly to modulate inflammatory mediators.ObjectivesPALACE 3 compared APR vs placebo (PBO) in patients with active psoriatic arthritis (PsA) and 1 or more...

FRI0529 Comparative risks for serious infections associated with biologics in high risk rheumatoid arthritis patients

BackgroundSerious infections are an important concern for patients with rheumatoid arthritis (RA) treated with biologic agents. However, insufficient data guide the optimal treatment in the high risk population.ObjectivesTo compare the...