Showing papers by "Arnon D. Cohen published in 2020"

Evaluating patients' unmet needs in hidradenitis suppurativa: Results from the Global Survey Of Impact and Healthcare Needs (VOICE) Project

Abstract: Background A needs assessment for patients with hidradenitis suppurativa (HS) will support advancements in multidisciplinary care, treatment, research, advocacy, and philanthropy. Objective To evaluate unmet needs from the perspective of HS patients. Methods Prospective multinational survey of patients between October, 2017 and July, 2018. Results Majority (63.7%, n=827) visited a physician ≥5 times prior to receiving formal HS diagnosis. Mean delay in diagnosis was 10.2 years (+/- 8.9 years). Patients experienced flare daily, weekly, or monthly in 23.0%, 29.8%, and 31.1%, respectively. Most (61.4%, n=798) rated recent HS-related pain as moderate or higher, while 4.5% described recent pain to be worst possible. Access to dermatology was rated as difficult by 37.0% (n=481). Patients reported visiting the emergency department and hospital ≥5 times for symptoms in 18.3% and 12.5%, respectively. An extreme impact on life was reported by 43.3% (n=563), and 14.5% were disabled due to disease. Patients reported high frequency of comorbidities, most commonly mood disorders. Patients were dissatisfied with medical or procedural treatments in 45.9% and 34.5%, respectively. Limitations Data was self-reported. Patients with more severe disease may have been selected. Conclusions HS patients have identified several critical unmet needs that will require stakeholder collaboration to meaningfully address.

Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council.

Abstract: Background Psoriasis severity categories have been important tools for clinicians to use in treatment decisions as well as to determine eligibility criteria for clinical studies. However, owing to the heterogeneity of severity classifications and their lack of consideration for the impact of psoriasis involvement of special areas or past treatment history, patients may be miscategorized, which can lead to undertreatment of psoriasis. Objective To develop a consensus statement on the classification of psoriasis severity. Methods A modified Delphi approach was developed by the International Psoriasis Council to define psoriasis severity. Results After completion of the exercise, 7 severity definitions were preferentially ranked. This most preferred statement rejects the mild, moderate, and severe categories in favor of a dichotomous definition: Psoriasis patients should be classified as either candidates for topical therapy or candidates for systemic therapy; the latter are patients who meet at least one of the following criteria: (1) body surface area >10%, (2) disease involving special areas, and (3) failure of topical therapy. Limitations This effort might have suffered from a lack of representation by all relevant stakeholders, including patients. Conclusion The consensus statement describes 2 categories of psoriasis severity, while accounting for special circumstances where patients may require systemic therapy.

Association between time to colonoscopy after a positive guaiac fecal test result and risk of colorectal cancer and advanced stage disease at diagnosis

Abstract: We evaluated time to colonoscopy after a positive guaiac-based fecal occult blood test (gFOBT) result and its association with the risk of overall colorectal cancer (CRC) and advanced-stage disease at diagnosis. We conducted a retrospective cohort study (2011-2013) within the Clalit Health Services, Israel. Participants were patients between 50 and 74 years old with a positive gFOBT result who had follow-up colonoscopies within 24 months. The exposure was time to colonoscopy, and the main outcome measure was a risk for overall and advanced CRC (defined as Stages III-IV). Odds ratios (ORs) and 95% confidence intervals (CIs) were adjusted for patient demographics and baseline risk factors. Of the 17,958 patients with positive gFOBT results (median age, 61 years [interquartile range, 56-67 years]; women, 52.2%), there were 685 cases of CRC and 156 cases of an advanced-stage disease diagnosed. The rate of cancer diagnosis at 0-3, 4-6, 7-9, 10-12 and 13-24 months was 3.9%, 2.5%, 3.5%, 4.2% and 7.3%, respectively (p < 0.001). Compared to colonoscopy follow-up within 0-3 months, risks for any CRC and advanced stage disease were higher for a follow-up of 12-24 months: OR, 1.97 (95% CI, 1.51-2.56) and 1.88 (95% CI, 1.43-2.46), respectively. For right-sided cancer (n = 194), an increased risk starts at 10 months, OR, 1.91 (95% CI 1.03-3.56). A result of 3-6 positive fields was significantly associated diagnosis of cancer (OR, 5.52; 95% CI, 4.71-6.46) and advanced stage disease (OR, 8.07; 95% CI, 5.74-11.36). Encouraging an early uptake of colonoscopy and targeting those with 10-24 months delay and a 3-6 positive fields is warranted.

Low Vitamin D Levels Predict Mortality in Ankylosing Spondylitis Patients: A Nationwide Population-Based Cohort Study.

Abstract: In this study, we aimed to examine the effect of vitamin D deficiency on all-cause mortality in ankylosing spondylitis (AS) patients and in the general population. This is a retrospective-cohort study based on the electronic database of the largest health-maintenance organization in Israel. AS patients who were first diagnosed between 2002-2007 were included. Controls were matched by age, gender and enrollment-time. Follow-up continued until death or end of study follow-up on 1 July 2019. Laboratory measures of serum 25-hydroxyvitamin-D levels during the entire follow-up period were obtained. A total of 919 AS patients and 4519 controls with a mean time of follow-up of 14.3 years were included. The mean age at the time of enrollment was 52 years, and 22% of them were females. AS was associated with a higher proportion of vitamin D deficiency (odds ratio 1.27 [95% confidence-interval (CI) 1.03-1.58]). In AS patients, insufficient levels of vitamin D (< 30 ng/mL) were significantly associated with increased incidence of all-cause mortality (hazard ratio (HR) 1.59 [95% CI 1.02-2.50]). This association was more prominent with the decrease in vitamin D levels (< 20 ng/mL, HR 1.63 [95% CI 1.03-2.60]; <10 ng/mL, HR 1.79 [95% CI 1.01-3.20]) and among male patients (< 30 ng/mL, HR 2.11 [95% CI 1.20-3.72]; <20 ng/mL, HR 2.12 [95% CI 1.19-3.80]; <10 ng/mL, HR 2.23 [95% CI 1.12-4.43]). However, inadequate levels of vitamin D among controls were not associated with an increased all-cause mortality. Our study has shown that vitamin D deficiency is more common in AS patients than controls and is linked to an increased risk for all-cause mortality. These results emphasize the need for randomized-controlled trials to evaluate the benefits of vitamin D supplementation as a secondary prevention of mortality in patients with chronic inflammatory rheumatic disease.

Mortality among patients with giant-cell arteritis: A large-scale population-based cohort study

Abstract: Objective Studies regarding mortality among patients with giant cell arteritis (GCA) have yielded conflicting results. Thus in this large population-based study we aimed to examine whether GCA is associated with increased mortality, and if so, the effect of age at diagnosis and sex on the association. Methods We used the medical database of Clalit Health Services for this retrospective cohort study. Followup was from January 1, 2002, and continued until death or end of followup on September 1, 2018. Incident GCA patients were compared with age- and sex-matched controls. Estimated median survival times were calculated using the Kaplan-Meier method. HR for all-cause mortality were obtained by the Cox proportional hazard model, adjusted for sociodemographic variables and cardiovascular risk factors. Results The study included 7294 patients with GCA and 33,688 controls. The mean age at start of followup was 72.1 ± 9.9 years with 69.2% females. Estimated median survival time was 13.1 years (95% CI 12.6–13.5) in patients with GCA compared with 14.4 years (95% CI 14.1–14.6) in controls (p 10 years after diagnosis (HR 1.14, 95% CI 1.02–1.3). The mortality risk was higher in patients diagnosed at ≤ 70 years of age [HR 1.5 (95% CI 1.14–1.99) 0–2 yrs; HR 1.38 (95% CI 1.1–1.7) > 10 yrs]. Conclusion Patients with GCA have a minor decrease in longterm survival compared to age- and sex-matched controls. The seen difference is due to excess mortality in the first 2 years, and > 10 years after diagnosis. Patients diagnosed ≤ 70 years of age are at greater risk.

Familial Mediterranean fever is associated with increased risk for ischaemic heart disease and mortality-Perspective derived from a large database.

Abstract: AIMS OF THE STUDY Familial Mediterranean fever (FMF) is a hereditary, auto-inflammatory disease, characterised by recurrent, self-limiting attacks of fever with inflammation of the serosal membranes, joints, and skin. Chronic inflammation was previously associated with increased risk for ischaemic heart disease (IHD). However, the association between FMF and IHD remains unclear. The objective of this study is to determine whether this association exists. METHODS Utilising the database of the largest health-care provider in Israel, a cross-sectional study was performed. The incidence of IHD was compared between patients diagnosed with FMF and age and sex-matched controls. Chi-square and t-test were used for categorial and continuous variables, and cox logistics regression model was used for multivariate analysis. Survival analysis was made using Kaplan-Meier plots and log-rank test. RESULTS The study included 7670 patients diagnosed with FMF and an equal number of controls without FMF. In a univariate analysis FMF was found to be associated with higher prevalence of IHD (OR 1.33) and increased mortality (OR 1.29). In a multivariate analysis FMF was found to be independently associated with increased risk for IHD (OR 1.44). CONCLUSION The study shows that FMF is associated with both increased risk for IHD and higher mortality rates. An early diagnosis and treatment of this disease can potentially improve patients' life expectancy and decrease cardiac comorbidities.

Patterns of healthcare services utilization associated with intimate partner violence (IPV): Effects of IPV screening and receiving information on support services in a cohort of perinatal women.

Abstract: Background While women experiencing intimate partner violence (IPV) face significant health consequences, their patterns of healthcare services (HCS) utilization are unclear, as are the effects of IPV screening and receiving information on these patterns. Objectives 1. Compare utilization patterns of five HCS (visits to family physician, gynecologist, specialist and emergency room, and hospitalization) in a cohort of perinatal women who reported experiencing versus not experiencing any IPV and IPV types (physical and/or sexual; emotional and/or verbal; social and economic); 2. Examine whether IPV screening, receiving information on support services, or both, affect patterns; and 3. Compare these associations between ethnic groups (Arab and Jewish women). Methods We conducted a prospective study using registry data on HCS utilization obtained from Israel’s largest Health Fund (Clalit) in the year following a 2014–2015 survey of a cohort of 868 perinatal women in Israel (327 Arab minority, 542 Jewish) on their reports of experiencing IPV, IPV screening, and receiving information. Using multivariate analysis, we calculated adjusted odds ratios (AOR) and 95% confidence intervals (CI) for the five HCS utilizations in association with reports of any IPV and IPV types. We adjusted for IPV screening, receiving information about services, and both, in the total sample, and separately among ethnic groups. Results Any IPV and IPV types had significant associations with some HCS utilization variables, with different directions and patterns for the ethnic groups. Experiencing IPV was associated with higher HCS utilization among Arab women, lower utilization in Jewish women. Arab women experiencing IPV were twice as likely to visit a gynecologist than women not experiencing IPV (AOR (95% CI) was 2.00, 1.14–3.51 for any IPV; 2.17, 1.23–3.81 for emotional and/or verbal IPV, and 1.83, 1.04–3.22, for social and economic IPV). Among Jewish women, experiencing any IPV was associated with lower likelihood of emergency-room visits (0.62, 0.41–0.93); and experiencing physical and/or sexual IPV was associated with lower likelihood of family physician visits (OR = 0.20, 0.05–0.82). Both IPV screening and receiving information were associated with lower HCS utilization among Arab women only. Conclusions Different HCS utilization patterns among women who reported experiencing versus not experiencing IPV in different ethnic groups suggest complex relationships that hinge on how HCS address women’s needs, starting with IPV screening and providing information. This might inform tailored programs to tackle IPV at the HCS, particularly for minority women.

Hidradenitis Suppurativa and Bipolar Disorders: A Population-Based Study.

Abstract: BACKGROUND Psychological comorbidities have been reported in patients with hidradenitis suppurativa (HS), yet only a few studies have investigated the possible association between HS and severe psychiatric disorders. The current study aimed to assess the association between HS and bipolar disorder, a major, chronic, psychiatric disease. METHODS A nationwide, population-based study was performed utilizing data from the Clalit Health Services (CHS) database in Israel. The study included 4,191 HS patients and 20,941 age- and gender-matched controls. A multivariate binary logistic regression, adjusted for demographic and behavioral risk factors, was performed. RESULTS A higher proportion of bipolar disorders was found among HS patients compared to controls (0.7 vs. 0.1%, respectively). There was an increased proportion of active smokers among HS patients than among controls (53.4 vs. 13.5%, respectively). In the multivariate analysis, adjusting for age, sex, and smoking, HS was found to be independently and positively associated with bipolar disorders (OR 2.12, 95% CI 1.21-3.27, p < 0.01), yet after controlling for body mass this association became nonsignificant. CONCLUSIONS Bipolar disorders are associated with HS. Future studies should explore whether cardiometabolic deficiencies might account for this association. Healthcare providers should consider this potential co-occurrence as it may impede patient compliance and require appropriate screening and treatment. Results also stress the need for a multidisciplinary approach to optimize management of the disease and its associated comorbidities.

Is there an association between alopecia areata and systemic lupus erythematosus? A population-based study.

Abstract: The coexistence of alopecia areata (AA) and systemic lupus erythematosus (SLE) has been described, but the association between these conditions is yet to be firmly established. We aimed to evaluate the association between AA and SLE using a large-scale real-life computerized database. A cross-sectional study was conducted comparing the prevalence of SLE among patients with AA and among age-, sex-, and ethnicity-matched control subjects. Chi-square and t tests were used for univariate analysis, and a logistic regression model was used for multivariate analysis. The study was performed utilizing the computerized database of Clalit Health Services ensuring 4.4 million subjects. A total of 51,561 patients with AA and 51,410 controls were included in the study. The prevalence of SLE was increased in patients with AA as compared to the control group (0.3% vs. 0.1%, respectively; OR, 2.1; 95% CI, 1.6–2.9; P < 0.001). The association increased consistently with age and was stronger among female and Jewish patients. In a multivariate analysis adjusting for sex, age, ethnicity, and other comorbidities, AA was still associated with SLE (OR, 2.1; 95% CI, 1.6–2.9; P < 0.001). To conclude, a significant positive association was observed between AA and SLE. Further longitudinal observational studies are necessary to establish these findings in other study populations. Physicians treating patients with AA may be aware of this possible association and may consider screening for SLE in patients with relevant symptoms.

Acne Keloidalis Nuchae and the Metabolic Syndrome: A Population-Based Study.

Abstract: The association between acne keloidalis nuchae (AKN) and the metabolic syndrome (MS) has been reported anecdotally. However, it is yet to be investigated in the setting of controlled studies, leaving this topic inconclusive in the current literature. The aim was to estimate the association between AKN and the MS and its components, utilizing one of the largest cohorts of patients with AKN. A retrospective, population-based, cross-sectional study was performed between 2005 and 2018. We utilized the database of Clalit Health Services, the largest public healthcare provider organization in Israel. The current study encompassed data collected from general community clinics, primary care, and referral centers, as well as from ambulatory and hospital care. A total of 2677 patients with AKN and 13,190 controls were included. The prevalence of the MS was greater in patients with AKN than in control subjects (16.1% vs. 6.6%, respectively; odds ratio [OR] 2.72; 95% confidence interval [CI] 2.40–3.08; P < 0.001). Obesity demonstrated the strongest association with AKN (OR 3.00; 95% CI 2.75–3.28), followed by type 2 diabetes mellitus (OR 2.47; 95% CI 2.20–2.77), hypertension (OR 1.82; 95% CI 1.63–2.05), and dyslipidemia (OR 1.60; 95% CI 1.46–1.75). Estimates were not altered significantly after controlling for putative confounding factors. A strong association was observed between AKN and the MS on the one hand, and with every one of its four components on the other. Physicians treating patients with AKN should be aware of this possible comorbidity. Patients with AKN should be carefully assessed for comorbid metabolic disorders.

Drug survival in patients with psoriasis is associated with the availability of biologic medications.

Abstract: BACKGROUND Drug survival rates in patients with psoriasis had been described extensively. Different survival rates of TNF-α inhibitors (TNFIs), ustekinumab and secukinumab were reported. OBJECTIVES To investigate drug survival rates of TNFIs, ustekinumab and secukinumab, with particular emphasis on the difference between ustekinumab and secukinumab. METHODS Survival analysis was performed in patients with moderate-to-severe psoriasis who received adalimumab, infliximab, etanercept, ustekinumab and secukinumab treatment in 2002-2018, using the Clalit Health Services database. Stratified analysis was performed according to biologic treatment lines. Multivariate analysis was performed adjusting for demographic variables, calendar year, metabolic syndrome, psoriatic arthritis, biologic treatment line, biologic naivety, co-administration of oral treatments and previous oral systemic treatment exposure. RESULTS Among 1459 patients treated with 3070 biologic medication courses, ustekinumab had a significantly higher crude survival as compared with TNFIs and secukinumab. The mean drug survival of ustekinumab, adalimumab, etanercept, infliximab and secukinumab was 43.5 (CI: 39.7-47.2), 38.2 (CI: 34.8-41), 33.9 (CI: 30.8-37.1), 28.2 (CI: 22.5-33.8) and 17.1 (CI: 15.6-18.6) months, respectively, with significant statistical differences for all comparisons (P < 0.001). The differences between ustekinumab and secukinumab were not significant following adjustment to factors that included treatment line (hazard rate 1.16, CI: 0.93-1.43). CONCLUSION Different drug survival rates between ustekinumab and secukinumab are determined by the treatment line and calendar year, reflecting the availability of biologic medications, and not only by the biologic attributes of each medication.

Psoriasis and Dementia: A Cross-sectional Study of 121,801 Patients.

Abstract: Data regarding the association between psoriasis and dementia are inconclusive. The aim of this study was to evaluate this association in the database of Clalit Health Services, Israel. A comparative analysis for the association between psoriasis, dementia and its risk factors was performed for the entire study population and in the subgroup of patients with moderate-to-severe psoriasis. The study included 121,801 patients with psoriasis, of whom 16,947 were diagnosed with moderate-to-severe psoriasis, and 121,802 controls. Psoriasis was associated with a lower prevalence of dementia relative to control subjects (1.6% vs 1.8%; odds ratio (OR) 0.85; 95% confidence interval (95% CI) 0.80-0.91; p < 0.001). Multivariate analysis adjusting for demographic variables, cardiovascular-related risk factors, and healthcare utilization demonstrated a significant inverse association between psoriasis and dementia in the entire study population (adjusted OR 0.86; 95% CI 0.76-0.96; p = 0.009), but not in the subgroup of patients with moderate-to-severe psoriasis (adjusted OR 0.91; 95% CI 0.81-1.02; p = 0.113). In conclusion, these data support the hypothesis that psoriasis is inversely associated with dementia.

Increased Risk of Pemphigus among Patients with Psoriasis: A Large-scale Cohort Study.

Abstract: Although pemphigus has recently been linked to psoriasis, the risk of emergence of pemphigus during the course of psoriasis is yet to be delineated. The aim of this study was to evaluate the risk of developing pemphigus during the course of psoriasis. A large-scale population-based longitudinal retrospective cohort study was performed to assess the hazard ratio (HR) of pemphigus among 68,836 patients with psoriasis relative to 68,836 age-, sex-, and ethnicity-matched controls. The incidence of pemphigus was 0.14 (95% confidence interval (95% CI) 0.10-0.19) and 0.04 (95% CI 0.02-0.07) per 1,000 person-years among psoriatic patients and controls, respectively. Patients with psoriasis were more than 3 times as likely to develop pemphigus (HR 3.25; 95% CI 1.70-6.21). The increased risk remained statistically significant following adjustment for several confounders (adjusted HR 3.19; 95% CI 1.67-6.11). To conclude, psoriasis is associated with an elevated risk of pemphigus. Further research is needed to explore the immunoserological profile of patients with a dual diagnosis.

Atopic Dermatitis and Celiac Disease: A Cross-Sectional Study of 116,816 Patients.

Abstract: Both atopic dermatitis and celiac disease are often accompanied by other immune-mediated disorders. The objective of this study was to evaluate the potential association between atopic dermatitis and celiac disease in a broad community-based population. A cross-sectional observational design was used. Demographic and clinical data were collected for patients enrolled in a large health management organization who were diagnosed with atopic dermatitis by a dermatologist in 2002–17. The presence of celiac disease/celiac disease-related morbidities was recorded for the whole group, for adults (age > 18 years), and for adults with moderate-to-severe atopic dermatitis. Findings were compared with a matched control group without atopic dermatitis. The study group included 116,816 patients of whom 45,157 were adults; 1909 adult patients had moderate-to-severe atopic dermatitis. Compared to the respective control subjects, the prevalence rate of celiac disease in the whole group was 0.6% vs. 0.4%; in the adults, 0.6% vs. 0.3%; and in the adults with moderate-to-severe atopic dermatitis, 0.8% vs. 0.3% (p < 0.001 for all). On multivariate analysis, atopic dermatitis was associated with a significantly higher prevalence of celiac disease (odds ratio = 1.609, 95% confidence interval 1.42–1.82, p < 0.001) in the entire study population and each subgroup. We observed a significant association between atopic dermatitis and celiac disease. This association emphasizes the need for timely screening of gastrointestinal morbidities in individuals with atopic dermatitis to prevent long-term complications.

Coping with Psoriasis or Hidradenitis Suppurativa: A Qualitative Study.

Abstract: Objective Psoriasis and hidradenitis suppurativa (HS) are both chronic inflammatory skin diseases with significant comorbidity. This study aimed to examine how patients with psoriasis or HS cope with their conditions on a personal and psychosocial level, especially in times of clinical exacerbation and symptom deterioration. Design This qualitative initial study used the phenomenology model to examine patients' lived experiences through the lens of their disease. Via semistructured interviews and content analysis, researchers aimed to describe the subjective reality of people with HS or psoriasis and identify any common issues. Patients and intervention Six open pilot interviews with three patients with HS and three patients with psoriasis uncovered five cardinal domains affecting patients' lives. After completing all the interviews, transcripts were analyzed and classified numerically by frequency of identified terms and keywords. After classifications and data ranking, the main issues were identified and separated into the five domains. Main results Researchers interviewed 20 patients (10 with psoriasis and 10 with HS). The five domains were distressing symptoms, struggling to cope with the disease, avoiding acute or recurrent eruptions, dealing with eruption, and information sources regarding the disease. Pain and pruritus were the most disturbing symptoms, and the remaining issues concerned the emotional, functional, and financial burden of these chronic conditions. Conclusions Even though the symptoms of HS and psoriasis are different, this study reveals common denominators regarding the emotional side of living with chronic skin disease.

Is Gout Associated with Pyoderma Gangrenosum? A Population-Based Case-Control Study.

Abstract: The coexistence of pyoderma gangrenosum (PG) and gout has been reported in individual patients; however, the association between these conditions has not been investigated. We aimed to assess the association between PG and gout and to examine whether the presence of gout predisposes to the development of PG. A population-based case-control study was conducted comparing PG patients (n = 302) with age-, sex-, and ethnicity-matched control subjects (n = 1497) with respect to the presence of preceding gout. Logistic regression models were utilized for univariate and multivariate analyses. The prevalence of preceding gout was greater in patients with PG than in control subjects (3.7% vs. 0.7%, respectively; p < 0.001). Gout was associated with a more than fivefold increase in the risk of PG (OR, 5.15; 95% CI, 2.21-11.98). After adjusting for confounding factors, gout emerged as a significant independent predictor of PG (adjusted OR, 4.08; 95% CI, 1.69-9.80). Gout preceded the diagnosis of PG by a median latency of 4.6 years. Patients with gout-associated PG were older, predominantly male, and had a higher prevalence of metabolic syndrome than other patients with PG. In conclusion, gout increases the risk of developing PG by more than fivefold. Physicians managing patients with gout and PG should be aware of this emerging association.

Patients with pemphigus are at an increased risk of developing rheumatoid arthritis: a large-scale cohort study

Abstract: Data regarding the association between pemphigus and rheumatoid arthritis (RA) is inconclusive and yet to be firmly established. In the current study, we aimed to evaluate the risk of developing RA during the course of pemphigus. A large-scale population-based longitudinal cohort study was conducted to evaluate the hazard ratio (HR) of RA among 1985 patients with pemphigus relative to 9874 age-, sex-, and ethnicity-matched control subjects. A multivariate Cox regression model was utilized. The incidence of RA was 1.07 (95% CI, 0.62-1.72) and 0.36 (95% CI, 0.24-0.52) per 1000 person-years among patients with pemphigus and controls, respectively. The lifetime prevalence of RA was 2.3% (95% CI, 1.7-3.1%) among cases and 1.8% (95% CI, 1.5-2.0%) among controls. Patients with pemphigus were more than twice as likely to develop RA as compared to control subjects (adjusted HR, 2.54; 95% confidence interval [CI], 1.31-4.92). The increased risk was robust to a sensitivity analysis that included only cases managed by pemphigus-related systemic medications (adjusted HR, 2.56; 95% CI, 1.30-5.05). In conclusion, pemphigus is associated with an increased risk of RA. Physicians treating patients with pemphigus should be aware of this possible association. Further research is required to better understand the mechanism underlying this association.

Hidradenitis suppurativa and pemphigus: a cross-sectional study.

Abstract: A recent study of comorbidities in hospitalized pemphigus patients in the United States has demonstrated a significant association of hidradenitis suppurativa (HS) and pemphigus, but this association has not been firmly established in other populations. A retrospective, cross-sectional study was undertaken to determine the prevalence of HS in patients with pemphigus and compare with control subjects. Regression analysis was performed to obtain ORs, and 95% CIs, to evaluate the prevalence between pemphigus patients and controls matched by age, sex, and ethnicity. Among the patients included in the study, 1985 patients had pemphigus and 9874 were control subjects. The average age of presentation of pemphigus was 72.1 ± 18.5 and the group was comprised of 59.8% females. Overall, the pemphigus group had lower rates of smoking (25.7% vs. 27.9%; P = 0.045). The prevalence of HS was greater in patients with pemphigus than in control subjects (OR 4.98; 95% CI 1.01–24.69; P < 0.001), with an even more prominent association among patients who have been prescribed “pemphigus-related treatments” (OR 6.30; 95% CI 1.27–31.22; P < 0.001). The study detected a significant association between HS and pemphigus in an Israeli population. Future prospective studies are needed to establish a temporal order of appearance and the mechanistic relationship between these entities.

The coexistence of gout in ankylosing spondylitis patients: a case control study

Abstract: Ankylosing spondylitis (AS) and gout are common inflammatory arthropathies. It had been claimed previously that the two conditions rarely coexist. The aim of this study was to compare the prevalence of gout in a population of AS patients to its prevalence in the general population. To conduct this population-based case–control study, data of adult patients with a physician diagnosis of AS were retrieved from the database of the largest health-care provider organization in Israel, Clalit Health Services. For each patient with AS, five age- and sex-matched subjects without AS were randomly selected from the same database. Different parameters including the existence of gout, hypertension, body mass index, socioeconomic status, and smoking were evaluated in both the AS and the control groups. The study included 3763 patients with AS and 19,214 controls. The proportion of gout in the AS group was higher than in the control group: 73 subjects in the AS group had gout, while only 107 subjects in the non-AS group had gout (1.94% and 0.56%, respectively, OR 3.53, P < 0.001). Logistic regression adjusting for possible confounding variables found that AS was independently associated with gout (OR 1.41, P = 0.037). Our study suggests that gout is not less common in AS patients in comparison with the general population, and that it might even be more common in AS patients.

Quantification of the relationship between pyoderma gangrenosum and Crohn's disease: a population-based case-control study.

Abstract: Although Crohn’s disease (CD) is an established underlying disease in pyoderma gangrenosum (PG), studies comparing patients with PG and controls with respect to the presence of CD are lacking. Cons...

Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis Council.

Abstract: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. A semiqualitative structured process was employed to approve the consensus statements on biosimilars using the nominal group technique. The final statements were validated by a survey of the paricipants. The approval of the consensus statements was predefined as >80% positive opinions. A consensus was reached in 36/38 statements regarding regulatory considerations, extrapolation of indication, interchangeability, substitution at the pharmacy level, pharmacovigilance, traceability, naming, biosimilar policy, education, and cost of biosimilars. Example statements include "Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so" and "Patients and patients' organisations should be involved in all decision making and policy development about the use of biosimilars." The International Psoriasis Council Biosimilar Working Group provides consensus statements for the use of biosimilars in the treatment of patients with psoriasis. We suggest that these statements provide global guidance to clinicians, healthcare organizations, pharmaceutical companies, regulators, and patients regarding the development and use of biosimilars in patients with psoriasis.

Familial Mediterranean fever association with schizophrenia: insights from big data analysis

Abstract: Introduction: Several autoimmune diseases have been associated with schizophrenia; however, little is known about putative links with auto-inflam matory conditions. We investigated the association between familial Mediterranean fever (FMF), a paradigmatic auto-inflammatory disease, and schizophrenia and assessed the impact of the latter on the survival of FMF patients. Material and methods: A case-control study was performed by utilising the database of Clalit Health Services, the largest health maintenance organisation in Israel. Familial Mediterranean fever patients were compared to ageand sex-matched controls in terms of prevalence of schizophrenia. The χ2 test was used to assess the distribution of categorical variables, while the t-test was applied for continuous variables. Analysis regarding survival was performed using Kaplan-Meier curves, log rank test, and multivariate Cox proportional-hazards method. Statistical analysis was performed using SPSS version 24.0, IBM, USA. Results: The study included 7747 FMF patients and 10,080 ageand sexmatched controls (case-control match 1 : 1.3). On univariate analysis, 50 FMF patients (0.6%) and 89 controls (0.9%) had schizophrenia. On multiple logistic regression model, FMF was inversely associated with schizophrenia (OR = 0.64 [95% CI: 0.43–0.90], p = 0.0173). Familial Mediterranean fever (HR = 1.43 [95% CI: 1.23–1.66]) and schizophrenia (HR = 3.97 [95% CI: 1.47–10.70]) were independently associated with all-cause mortality. However, schizophrenia as a co-morbidity in FMF subjects did not worsen their prognosis (HR = 2.17 [95% CI: 0.60–7.86]). Conclusions: Familial Mediterranean fever patients have a significantly lower proportion of schizophrenia than controls. The current evidence shows that auto-inflammatory conditions confer protection against schizophrenia development. Patients with either FMF or schizophrenia are at higher risk of all-cause mortality, a finding that calls for assessment of better medical management of mortality outcomes.

Op0253 autoantibody status in dermatomyositis and polymyositis patients defines both cancer risk and survival with ana negativity in cases with concomitant cancer having a worse survival

Abstract: Background: We previously reported that ANA-negative cases with systemic sclerosis (SSc) and concomitant cancer had a worse survival than ANA-positive cases with associated cancer possibly suggesting that humoral mediated autoimmunity conferred a survival advantage (1). Dermatomyositis (DM) and polymyositis (PM) are two immune-mediated myopathies associated with numerous autoantibodies. Objectives: The present large-scale, population-based study tested the hypothesis that humoral autoimmunity associated with cancer in solid/haematological malignancies impacted on DM/PM patient survival. Methods: Over 2000 cases with either DM or PM were recruited from the Clalit Health Service (CHS) chronic diseases registry, one of the largest healthcare maintenance Israeli organization, serving approximately half of the entire country’s population. Over 10000 matched controls were recruited. The data collected range from 2000 to 2018. Results: Altogether 12,278 subjects were recruited (2,085 cases, and 10,193 controls, 5,042 males, 41.1%, and 7,236 females, 58.9%). Among cases, 1,475 individuals (70.7%) were diagnosed with DM, whereas 610 (29.3%) with PM. Mean age was 47.81±22.51 years. 1,379 cases of cancers (11.2%) were diagnosed. At the univariate analysis and as expected, the rate of malignancies was significantly (p Concerning prognosis, ANA positivity in PM/DM was associated with a better prognosis for all cancers (OR 0.39 [95% 0.24-0.63], p=0.0001). For individual cancer types; thyroid cancer (OR 0.39 [95% 0.24-0.63], p=0.0001), gastric cancer (OR 0.40 [95% 0.25-0.64], p=0.0001), kidney cancer (OR 0.39 [95% 0.24-0. 62], p=0.0001), acute leukaemia (OR 0.40 [95% 0.25-0.65], p=0.0002), non-Hodgkin’s lymphoma (OR 0.39 [95% 0.25-0.63], p=0.0001), but not for myelodysplastic syndrome. The main cancers linked to PM/DM were thyroid cancer (OR 3.17 [95%CI 2.27-4.43]), gastric cancer (OR 5.96 [95%CI 4.24-8.38]), kidney cancer (OR 3.83 [95%CI 1.02-14.31], p=0.0462), and myelodysplastic syndrome (OR 2.01 [95%CI 1.17-3.46], p=0.0111). Regarding gastric cancer, positivity for anti-RNP (OR 5.68 [95%CI 3.02 to 10.71], p Conclusion: ANA positivity is an independent predictor of favorable prognosis in PM/DM patients with cancer, possibly suggesting that cancer directed humoral autoimmunity may have some benefit. Therefore, humoral autoimmunity in SSc and PM/DM is a broad mechanism that confers a survival advantage and is relevant for disease understanding and elucidating optimal anti tumoural immunity in the current age of cancer immunotherapy. References: [1]Watad A, McGonagle D, Bragazzi NL, Tiosano S, Comaneshter D, Shoenfeld Y, Cohen AD, Amital H. Autoantibody status in systemic sclerosis patients defines both cancer risk and survival with ANA negativity in cases with concomitant cancer having a worse survival. Oncoimmunology. 2019 Mar 24;8(6):e1588084. Disclosure of Interests: Abdulla Watad: None declared, Dennis McGonagle Grant/research support from: Janssen Research & Development, LLC, Merav Lidar: None declared, Nicola Luigi Bragazzi: None declared, Doron Comanesther: None declared, Arnon Cohen: None declared, Howard Amital: None declared

Sat0603 systemic sclerosis is an independent risk factor for ischemic heart disease with an additional risk in those positive for certain anti-phospholipid antibodies: a very large case-control study

Abstract: Background: A higher prevalence of ischemic heart disease (IHD) in patients with systemic sclerosis (SSc) was reported. However, contrasting findings were published concerning the role of SSc-related autoantibodies in IHD risk which remains controversial. Objectives: The current study explored the link between SSc and IHD, impact of putative links on SSc mortality and the role of SSc-related and antiphospholipid autoantibodies in disease associated IHD. Methods: A large cohort study utilising the Clalit-Health-Service (CHS) database was conducted on 2,431 SSc patients and 12,710 age- and sex matched controls. The proportion of IHD was compared between patients diagnosed with SSc and age- and gender-matched controls. The role of SSc-linked and antiphospholipid autoantibodies in disease associated IHD was assessed. Results: The rate of IHD was significantly higher in SSc than controls (20.4% vs 15.0%, p Conclusion: Patients with SSc are at higher risk for developing IHD with an additional risk for the latter in those positive for aCL or anti-beta2GPI. A high degree of suspicion is needed during routine patient follow-up and pre-emptive screening should be considered. Disclosure of Interests: Abdulla Watad: None declared, Dennis McGonagle Grant/research support from: Janssen Research & Development, LLC, Nicola Luigi Bragazzi: None declared, Doron Comanesther: None declared, Arnon Cohen: None declared, Merav Lidar: None declared, Howard Amital: None declared