After initially hypothesizing a positive relationship between use of renin-angiotensin-aldosterone system inhibitors and risk of coronavirus disease 2019 (COVID-19), more recent evidence suggests negative associations. We examined whether COVID-19 risk differs according to antihypertensive drug class in patients treated by ACE (angiotensin-converting enzyme) inhibitors and angiotensin receptor blockers (ARBs) compared with calcium channel blockers (CCBs). Three exclusive cohorts of prevalent ACE inhibitors, ARB and CCB users, aged 18 to 80 years, from the French National Health Insurance databases were followed from February 15, 2020 to June 7, 2020. We excluded patients with a history of diabetes, known cardiovascular disease, chronic renal failure, or chronic respiratory disease during the previous 5 years, to only consider patients treated for uncomplicated hypertension and to limit indication bias. The primary end point was time to hospitalization for COVID-19. The secondary end point was time to intubation/death during a hospital stay for COVID-19. In a population of almost 2 million hypertensive patients (ACE inhibitors: 566 023; ARB: 958 227; CCB: 358 306) followed for 16 weeks, 2338 were hospitalized and 526 died or were intubated for COVID-19. ACE inhibitors and ARBs were associated with a lower risk of COVID-19 hospitalization compared with CCBs (hazard ratio, 0.74 [95% CI, 0.65–0.83] and 0.84 [0.76–0.93], respectively) and a lower risk of intubation/death. Risks were slightly lower for ACE inhibitor users than for ARB users. This large observational study may suggest a lower COVID-19 risk in hypertensive patients treated over a long period with ACE inhibitors or ARBs compared with CCBs. These results, if confirmed, tend to contradict previous hypotheses and raise new hypotheses.
IMPORTANCE Biologics and targeted therapies, such as apremilast, are efficient treatments to manage moderate to severe psoriasis. More information about the risk of serious infection is needed for the newest treatment options in a real-world setting.OBJECTIVE To assess the risk of serious infection among biologics and apremilast used to treat psoriasis, with etanercept as the comparator. DESIGN, SETTING, AND PARTICIPANTSThis nationwide cohort study from France involved data from the National Health Data System covering approximately 99% of the French population. All adults with psoriasis, defined as receiving at least 2 prescriptions of a topical vitamin D derivative within a 2-year period, registered in the database between January 1, 2008, and May 31, 2019, were eligible. The study population included those who were new users of biologic agents or apremilast (ie, without any prescriptions of a biologic or apremilast during the previous year). Patients with HIV infection or a history of cancer, transplant, or serious infection were excluded. End of follow-up was January 31, 2020.MAIN OUTCOME MEASURES The primary end point was a serious infection in a time-to-event analysis using propensity score-weighted Cox proportional hazards regression models, estimating weighted hazard ratios (wHRs) and 95% CIs.RESULTS A total of 44 239 new users of biologic treatment were identified (mean [SD] age, 48.4 [13.8] years; 22 866 [51.7%] men; median follow-up, 12 months [interquartile range, 7-24 months]). A total of 29 618 (66.9%) were prescribed a tumor necrosis factor inhibitor first, 6658 (15.0%) an interleukin (IL) 12/23 inhibitor, 4093 (9.3%) an IL-17 inhibitor, 526 (1.2%) an IL-23 inhibitor, and 3344 (7.6%) apremilast. The total number of serious infections was 1656, and the overall crude incidence rate was 25.0 (95% CI, 23.8-26.2) per 1000 person-years. The most frequent serious infections were gastrointestinal infections (645 patients [38.9%]). After adjusting for time-dependent covariables, risk of serious infections was higher for new users of adalimumab (wHR, 1.22; 95% CI, 1.07-1.38) or infliximab (wHR, 1.79; 95% CI 1.49-2.16) vs etanercept, whereas ustekinumab was associated with a lower risk of having a serious infection (wHR, 0.79; 95% CI, 0.67-0.94). Risk of serious infections was not increased for new users of IL-17 and the IL-23 inhibitor guselkumab or apremilast vs etanercept. Risk of serious infections was increased with concomitant nonsteroidal anti-inflammatory drugs or systemic corticosteroids. CONCLUSIONS AND RELEVANCEIn this cohort study of individuals with moderate to severe psoriasis, risk of serious infections was increased in new users of infliximab and adalimumab vs etanercept, whereas ustekinumab users had lower risk of having a serious infection but not new users of IL-17 and IL-23 inhibitors or apremilast. Other observational studies are needed to confirm results for the most recent drugs.
cne has been reported to be the most common chronic inflammatory skin disease worldwide, [1][2][3] occurring mostly in the 15-to 17-year age group. [4][5][6] Epidemiologic data from Western countries suggest that the prevalence of acne in adults older than 25 years is approximately 50%, with female predominance. [7][8][9][10] In this so-called adult acne group, there are 2 distinct populations: patients who developed acne during adolescence and have persistent acne and those who developed de novo acne during adulthood.Adult acne has various consequences; one of these is psychological harm associated with low self-esteem, poor perception of one's body, social isolation, and depressive symptoms. 11,12 Acne is reported to have the same emotional, social, and psychological consequences as chronic diseases, such as asthma, arthrosis, epilepsy, and diabetes. 13 Acne appears to be a multifactorial disease in which both genetic and environmental factors have pivotal roles. Endocrine disorders and genetic predispositions can lead to the development of acne; in addition, cosmetic products, tobacco use, stress, exposure to pollution, and dietary behavior may be associated with the development and severity of acne. [14][15][16][17][18][19] People with acne have been reported to believe that consumption of foods affects their condition. Although chocolate, fatty foods, and milk are frequently thought to be responsible, 20,21 data on the role of nutrition in acne are scarce. It has been hypothesized that a glycemic diet 22,23 or the consumption of dairy products (particularly milk) 24-28 is associated with the pathophysiologic mechanism of acne via androgens and insulinlike growth factor-1 (IGF-1). [29][30][31][32] However, published studies presented several limitations. IMPORTANCE Acne is a chronic, multifactorial inflammatory disease. The association between consumption of dairy products and fatty and sugary foods and occurrence and progression of acne remains unclear.OBJECTIVE To assess the association between dietary behavior and current acne in adults. DESIGN, SETTING, AND PARTICIPANTSA cross-sectional study was performed as part of the NutriNet-Santé study, which is an ongoing observational, web-based cohort study that was launched in France in May 2009. The present study was conducted from November 14, 2018, to July 8, 2019. A total of 24 452 participants completed an online self-questionnaire to categorize their acne status: never acne, past acne, or current acne. Associations between dietary behavior (food intake, nutrient intake, and the dietary pattern derived from a principal component analysis) and current or past acne were studied in multinomial logistic regression models adjusted for potential confounding variables (age, sex, physical activity, smoking status, educational level, daily energy intake, number of dietary records completed, and depressive symptoms). RESULTSThe 24 452 participants (mean [SD] age, 57 [14] years; 18 327 women [75%]) completed at least 3 dietary records. Of these, 11 324 individuals (46...
Objective PsA is a chronic inflammatory arthritis with heterogeneous disease manifestations. Data on the prevalence of PsA in adults differ widely depending on the study and the country. This study aimed to estimate the prevalence and incidence of PsA in France, characterize comorbidities associated to PsA and identify prescribed treatments. Methods This nationwide cohort study involved the administrative healthcare database (Système National des Données de Santé) of the French health insurance scheme linked to the national hospital discharge database. All adults with PsA registered in the database and identified with a specific International Classification of Diseases, 10th revision code (M07) were included between 1 January 2015 and 31 December 2018. Results A total of 63 598 patients were identified as having PsA [55.9 years (s.d. 14.4), 45.6% males]. The prevalence of PsA was estimated at 0.1% and the incidence at 8.4 per 100 000 person-years in the general population. The most common comorbidities were hypertension, diabetes, chronic obstructive pulmonary disease and dyslipidaemia. The prevalence of treatment with conventional synthetic DMARDs (csDMARDs), biological or biosimilar DMARDs (b/bsDMARDs) and apremilast for PsA was 25.9% (16 453), 30.4% (19 325) and 3.5% (2231), respectively. Overall, 8966 (14.1%) patients were new users of csDMARDs, 8311 (13.1%) were new users of b/bsDMARDs and 1529 (7.4%) were new users of apremilast. The most common first-line csDMARD was methotrexate (70.9%) and the most frequent first-line b/bsDMARD was adalimumab (30.8%). Conclusion Our results lead to a better understanding of PsA. Results were similar to those from other published studies using other data sources, which highlights the reliability of insurance databases for studies.
Objective Several biological disease-modifying anti-rheumatic drugs (bDMARDs) have demonstrated anti-inflammatory effects in psoriatic arthritis (PsA). However, their comparative cardiovascular safety profiles remain unknown. We evaluated the risk of major adverse cardiovascular events (MACEs) in PsA patients on therapy with different classes of bDMARDs and apremilast. Methods This nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. All adults with PsA who were new users of bDMARDs/apremilast (neither in the year before the index date) during 2015–2019 were included. Patients with previous cardiovascular diseases were excluded. End of follow-up was December 31, 2019. The primary end point was an occurrence of MACE in a time-to-event analysis with propensity score-weighted Cox and Fine-Gray models. Results Between 2015 and 2019, we included 9,510 bDMARD new users (mean age 48.5 ± 12.7 years; 42% men), including 7,289 starting a TNF inhibitor, 1,058 an IL12/23 inhibitor and 1,163 an IL17 inhibitor, with 1,885 apremilast new users (mean age 54.0 ± 12.5 years; 44% men). MACEs occurred in 51 (0.4%) patients. After propensity score weighting, the risk of MACEs was significantly greater with IL12/23 (HRw 2.0, 95%CI 1.3–3.0) and IL17 (HRw 1.9, 95%CI 1.2–3.0) inhibitors than TNF inhibitors, with no significant increased risk with apremilast (HRw 1.3, 95%CI 0.8–2.2). Similar results were observed with the Fine-Gray competing-risks survival model. Conclusion Analysis of a large database revealed a small overall number of MACEs, and the risk of MACEs was greater for PsA new users of IL12/23 and IL17 vs TNF inhibitors.
high-dose corticosteroids. The broad spectrum of secondary autoimmune complications under ICIs should be taken into account. 3 In particular, in the adjuvant treatment setting, close collaboration between dermato-oncologists, neurologists and other specialists is critical for establishing the correct diagnosis and patient management.
Objective. To investigate whether the initiation of treatment with an interleukin-17 inhibitor (IL-17i) in real life is associated with a higher risk of inflammatory bowel disease (IBD) in patients who had both psoriasis (PsO) and psoriatic arthritis (PsA)/ankylosing spondylitis (AS).Methods. This nationwide cohort study was conducted using the French National Health Data System database. All adult patients with PsO and PsA/AS who were identified as having newly initiated treatment with an IL-17i during 2016-2019 were included. As controls, patients with PsO and PsA/AS who had newly initiated either 1) apremilast or 2) etanercept (ETN) during this period but had not received IL-17i were included. The follow-up end date was September 30, 2019. The primary end point was the risk of occurrence of IBD associated with exposure to an IL-17i compared to exposure to the other treatments, as determined in a time-to-event analysis with propensity score-weighted Cox and Fine-Gray proportional hazards models.Results. The study included a total of 16,793 new IL-17i users (mean AE SD age 48.4 AE 13 years, 45% men), 20,556 new apremilast users (age 52.6 AE 15 years, 54% men), and 10,294 new ETN users (age 46.3 AE 15 years, 44% men). New IL-17i users and new ETN users had received more biologics for their underlying disease compared to new apremilast users. IBD occurred in 132 patients: 72 new IL-17i users (0.43%), 11 new apremilast users (0.05%), and 49 new ETN users (0.48%). Most IBD cases occurred after 6 months of exposure (82%, 55%, and 76%, respectively). After propensity score weighting, the risk of IBD was significantly greater among patients initiating an IL-17i compared to those initiating apremilast (weighted hazard ratio [HR] 3.8 [95% confidence interval (95% CI) 2.1-6.8]). No difference in the risk of IBD between new IL-17i users and new ETN users was observed (weighted HR 0.8 [95% CI 0.5-1.2]).Conclusion. Patients with PsO and PsA/AS who initiate treatment with an IL-17i do not have a higher risk of developing IBD when compared to patients initiating ETN who display the same severity of underlying disease. These results need to be confirmed in other large studies of patients with PsO and PsA/AS.
Summary Background In reported systematic reviews and meta‐analyses of randomized controlled trials (RCTs) assessing treatments for psoriasis, the proportion of serious adverse events (SAEs) did not differ between treatments and placebo. Including cases of psoriasis worsening as SAEs may explain the lack of difference. Objectives This systematic review and meta‐analysis aimed to explore this possibility. Methods Among the 140 RCTs included in the Living Network Cochrane Review (last search on 8 May 2019), we selected those comparing a biologic treatment against placebo. The primary outcome was the numbers of SAEs in the treatment and placebo arms after excluding cases of psoriasis worsening. Secondary outcomes were the number of adverse events (AEs) of special interest. The trial was registered on PROSPERO (CRD42019124495). Results We analysed 51 RCTs. Of these, 21 included at least one anti‐tumour necrosis factor (TNF)‐α arm, 15 one anti‐interleukin (IL)‐17 arm, 11 one anti‐IL‐23 arm and nine one anti‐IL‐12/23 arm. With cases of psoriasis worsening included, the risk of occurrence of SAEs between biologic treatments and placebo did not differ: risk ratio (RR) 1·09, 95% confidence interval (CI) 0·88–1·36. After excluding cases of psoriasis worsening, the RR became significant (RR 1·30, 95% CI 1·02–1·65). By drug class, the RRs were for anti‐TNF‐α, 1·68 (95% CI 1·11–2·54; no missing data); anti‐IL‐17, 1·28 (95% CI 0·88–1·85; no missing data); anti‐IL‐23, 0·95 (95% CI 0·59–1·52; no missing data) and anti‐IL‐12/23, 1·18 (95% CI 0·72–1·94; no missing data). We were unable to examine potential differences in AEs of special interest between biologic treatments and placebo arms because of the small number of events. Conclusions On excluding cases of worsening psoriasis, the risk of occurrence of SAEs is higher in the biologic than in the placebo arm. Given the rare events, we could not highlight whether this higher risk of SAEs was related to AEs of special interest. Reporting of SAEs in clinical trials has to be changed to provide more transparency through the separate reporting of disease flares leading to hospital admission and other SAEs.
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