Patient-reported outcomes in European spondyloarthritis patients: a systematic review of the literature

Objective: This review aims to summarize the current literature on patient-reported outcomes (PROs) in spondyloarthritis (SpA). Patients and methods: We performed a systematic literature review to identify studies (original articles and narrative and systematic reviews) regarding PROs (health-related quality of life [HRQoL], satisfaction, preferences, adherence/compliance, and persistence) in SpA patients published in the European Union through December 2016. International databases (Medline/ PubMed, Cochrane Library, ISI Web of Knowledge, Scopus) were searched using keywords in English. The methodological quality of the studies was assessed using the Oxford Centre for Evidence-Based Medicine criteria. Results: A total of 26 publications met the inclusion criteria. Generally, studies indicated that SpA has a negative impact on patients’ HRQoL. In patients with ankylosing spondylitis, physical domains were more affected than emotional ones, whereas for psoriatic arthritis, both physical and psychological factors were strongly affected by the disease. Data indicated that biological agents (BAs) greatly contributed to improvement in HRQoL in both ankylosing spondylitis and psoriatic arthritis patients. Findings on compliance with BAs were heterogeneous. However, persistence rates exceeded 50% irrespective of the BA administered. Results on preferences indicated that most SpA patients prefer being involved in decisions regarding their treatment and that besides efficacy and safety, frequency and route of administration may influence patients’ preferences for BAs. Conclusion: Implementing management programs for SpA patients focuses on the physical, emotional, and social consequences of the disease, in addition to assessing and including patient preferences in the treatment decision-making process, could be crucial to improve patients’ HRQoL and ensure their satisfaction and compliance with treatment

COVID-19 patients with psoriasis and psoriatic arthritis on biologic immunosuppressant therapy versus apremilast in North Spain

Immunosuppressive and immunomodulatory treatments are critical for the management of inflammatory and autoimmune conditions such as psoriasis or psoriatic arthritis. Similar to those illnesses, the lung injury and acute respiratory distress shown in coronavirus disease 2019 (COVID‐19) patients are the result of a disruption in the balance of pro‐ and anti‐inflammatory cytokines. This hyperinflammatory response to severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), associated with the severity of the coronavirus disease, is called the cytokine storm. There is a growing concern regarding how patients on immunosuppressant biologic therapies might be at higher risk of being infected and whether they need to discontinue their treatment preemptively. Clinical data on COVID‐19‐infected patients with psoriasis or psoriatic arthritis are still scarce. Here, we presented seven cases of these type of patients. The patient infected with COVID‐19 on apremilast and the one on apremilast with infected spouse showed the best safety profile and mildest symptoms. One of the secukinumab patients also presented a relatively good outcome. Infliximab patients and the one with serious comorbidities showed the worst outcome. Even though more clinical data are yet needed to draw strong conclusions, apremilast could be a safer alternative for dermatology and rheumatology patients in case of clinically important active infection

Influence of comorbidities not associated with fibromyalgia on neuropathic pain in patients with psoriatic arthritis: relationship with clinical parameters

ObjectiveNeuropathic pain (NP) may influence disease activity assessment in patients with psoriatic arthritis, this relationship being traditionally based on the presence of concomitant fibromyalgia. We analyzed the influence of other comorbidities on NP and the relationship between pain and various clinical parameters.MethodsA cross-sectional study was conducted in patients diagnosed with psoriatic arthritis, excluding patients with a previous diagnosis of fibromyalgia, depression, anxiety, diabetes and/or dyslipidemia under treatment. NP was identified using the painDETECT questionnaire (score > 18). Obesity and related clinical parameters, anxious and depressive symptoms, sleep quality and fatigue were assessed as comorbidities. Disease activity was measured using the clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) in peripheral involvement, the ASDAS-PCR in axial involvement, functioning and disease impact were measured using the Health Assessment Questionnaire-Disability Index and 12-item Psoriatic Arthritis Impact of Disease questionnaire, respectively.ResultsOverall, 246 patients were included (136 men; 55%). The mean age was 53.4 ± 11.0 years. Forty-two patients had NP (17.1%). Patients with NP had higher leptin levels (OR: 1.03, 95% CI: 1.007–1.056; p < 0.01) and poor sleep quality (OR: 1.20, 95% CI: 1.09–1.297; p < 0.001). Patients with NP also had greater fatigue NRS (6.2 ± 2.2 vs. 2.4 ± 0.19, p < 0.001). Patients with NP had higher cDAPSA score (17.3 ± 5.4 vs. 8.9 ± 6.5, p < 0.001), poorer functioning (1.1 ± 0.5 vs. 0.4 ± 0.5, p < 0.001) and greater disease impact (6.1 ± 1.7 vs. 2.6 ± 1.9, p < 0.001).ConclusionNP was correlated with sleep quality and serum leptin and may be associated with worse disease activity, functioning and disease impact

PsABIOnd study and eDaily substudy design: long-term effectiveness and safety of guselkumab and IL-17 inhibitors in routine clinical practice in patients with psoriatic arthritis

Introduction: Randomised clinical studies in psoriatic arthritis (PsA) do not always reflect patients in routine clinical practice. Large-scale data from routine practice are needed to better understand drug persistence, effectiveness and long-term safety of therapeutic agents. Methods: PsABIOnd is an international, prospective, observational study designed to collect long-term routine care data in patients with PsA who receive guselkumab (an interleukin-23 [IL-23] inhibitor) or an interleukin-17 (IL-17) inhibitor. Adult patients (≥ 18 years) with a confirmed diagnosis of PsA who are starting guselkumab or any approved IL-17 inhibitor as a first, second, third or fourth line of PsA treatment and who provide written informed consent will be eligible to participate. Participants will be followed for a maximum of 36 months (+3 months) from the start of treatment. Study visits will occur in line with the standard of care, approximately every 6 months, plus an additional visit at 3 months after the start of treatment. eDaily by PsABIOnd - aneHealth substudy, will document the impact of these treatments on wellbeing and symptoms in a subgroup of participants over a 24-week (+4 weeks) observation period on treatment. Planned Outcomes: The primary objective of PsABIOnd is to evaluate treatment persistence with guselkumab and IL-17 inhibitors. Data sources will include validated electronic patient-reported outcomes (ePROs) and physician-completed assessments. Safety data will be collected through reporting adverse events. The eDaily by PsABIOnd substudy will use wearable and digital technologies for continuous activity and sleep monitoring, and frequent patient eDiary and ePRO collection to provide a more detailed and comprehensive picture of PsA. Trial Registration: ClinicalTrials.gov identifier: NCT05049798

A Single Nucleotide Polymorphism in the Il17ra Promoter Is Associated with Functional Severity of Ankylosing Spondylitis

The aim of this study was to identify new genetic variants associated with the severity of ankylosing spondylitis (AS). We sequenced the exome of eight patients diagnosed with AS, selected on the basis of the severity of their clinical parameters. We identified 27 variants in exons and regulatory regions. The contribution of candidate variants found to AS severity was validated by genotyping two Spanish cohorts consisting of 180 cases/300 controls and 419 cases/656 controls. Relationships of SNPs and clinical variables with the Bath Ankylosing Spondylitis Disease Activity and Functional Indices BASDAI and BASFI were analyzed. BASFI was standardized by adjusting for the duration of the disease since the appearance of the first symptoms. Refining the analysis of SNPs in the two cohorts, we found that the rs4819554 minor allele G in the promoter of the IL17RA gene was associated with AS (p<0.005). This variant was also associated with the BASFI score. Classifying AS patients by the severity of their functional status with respect to BASFI/disease duration of the 60th, 65th, 70th and 75th percentiles, we found the association increased from p60 to p75 (cohort 1: p<0.05 to p<0.01; cohort 2: p<0.01 to p<0.005). Our findings indicate a genetic role for the IL17/ILRA axis in the development of severe forms of AS

Mutation analysis of the LCE3B/LCE3C genes in Psoriasis

<p>Abstract</p> <p>Background</p> <p>An association between a common deletion comprising the late cornified envelope LCE3B and LCE3C genes (LCE3C_LCE3B-del) and Psoriasis (Ps) has been reported. The expression of these LCE genes was induced after skin barrier disruption and was also strong in psoriatic lesions. The damage to the skin barrier could trigger an epidermal response that includes the expression of genes involved in the formation of skin barrier.</p> <p>Methods</p> <p>We determined the LCE3C_LCE3B-del genotype in 405 Ps patients and 400 healthy controls from a Northern Spain region (Asturias). These patients and controls were also genotyped for the rs4112788 single nucleotide polymorphism, in strong linkage disequilibrium with the LCE3C_B cluster. The LCE3B and LCE3C gene variant was determined in the patients through SSCA, DHPLC, and direct sequencing.</p> <p>Results</p> <p>Allele and genotype frequencies did not differ between patients and controls for the rs4112788 and LCE3C_LCE3B-del polymorphisms. However, del/del homozygotes were significantly higher among patients with chronic plaque type Ps who did not develop arthritis (p = 0.03; OR = 1.4; 95%CI = 1.03-1.92). The analysis of the coding sequence of LCE3B and LCE3C in the patients who had at least one copy of this showed that only one patient has a no previously reported LCE3B variant (R68C).</p> <p>Conclusion</p> <p>Our work suggested that homozygosity for a common LCE3C_LCE3B deletion contributes to the risk of developing chronic plaque type Ps without psoriatic arthritis. Our work confirmed previous reports that described an association of this marker with only skin manifestations, and supported the concept of different genetic risk factors contributing to skin and joint disease.</p

An international multicentre analysis of current prescribing practices and shared decision-making in psoriatic arthritis

Objectives Shared decision-making (SDM) is advocated to improve patient outcomes in PsA. We analysed current prescribing practices and the extent of SDM in PsA across Europe. Methods The ASSIST study was a cross-sectional observational study of PsA patients ≥18 years of age attending face-to-face appointments between July 2021 and March 2022. Patient demographics, current treatment and treatment decisions were recorded. SDM was measured by the clinician’s effort to collaborate (CollaboRATE questionnaire) and patient communication confidence (PEPPI-5 tool). Results A total of 503 patients were included from 24 centres across the UK, France, Germany, Italy and Spain. Physician- and patient-reported measures of disease activity were highest in the UK. Conventional synthetic DMARDs constituted a higher percentage of current PsA treatment in the UK than continental Europe (66.4% vs 44.9%), which differed from biologic DMARDs (36.4% vs 64.4%). Implementing treatment escalation was most common in the UK. CollaboRATE and PEPPI-5 scores were high across centres. Of 31 patients with low CollaboRATE scores (<4.5), no patients with low PsAID-12 scores (<5) had treatment escalation. However, of 465 patients with CollaboRATE scores ≥4.5, 59 patients with low PsAID-12 scores received treatment escalation. Conclusions Higher rates of treatment escalation seen in the UK may be explained by higher disease activity and a younger cohort. High levels of collaboration in face-to-face PsA consultations suggests effective implementation of the SDM approach. Our data indicate that in patients with mild disease activity, only those with higher perceived collaboration underwent treatment escalation. Prospective studies should examine the impact of SDM on PsA patient outcomes

Non-Physical Disease Facets in Spondyloarthritis: An ASAS Health Index-Based Analysis between Psoriatic Arthritis and Axial Spondyloarthritis

Background: Psychosocial health is a key driver of quality of life (QoL) in axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), but it is often overlooked in clinical practice. We aimed to analyze this aspect of QoL by using the Assessment of SpA International Society&ndash;Health Index (ASAS HI) in both SpA phenotypes. Patients and methods: One hundred and eleven patients with axSpA and 90 with PsA were consecutively recruited from two rheumatology centers. In both populations, the categories of stress handling (ASAS HI items #11 and 17) and emotional functions (ASAS HI item #13) were analyzed based on the International Classification of Functioning, Disability, and Health (ICF). A multivariate regression model was used to analyze the explanatory factors associated with positive responses to these items. Results: Thirty-four of the 90 PsA patients (37.8%) and 37/111 of the patients (33.3%) with axSpA reported a positive response to at least one of the stress-handling items. Compared to the patients with PsA, patients with axSpA were less likely to report stress-handling issues (OR 0.48, p &lt; 0.05). Thirty-one of the 90 PsA patients (34.4%) and 44/111 of the patients (39.6%) with axSpA reported positive responses to item #13. In both groups of SpA patients, disease activity and severity (OR 6.6, p &lt; 0.001) were independently associated with alterations in psychosocial health. Compared with those in the axSpA group, the psychosocial health items were better correlated with each other and with the ASAS HI sum score in the PsA group. Conclusions: Psychosocial health is frequently altered in SpA. Both disease activity and severity are associated with this issue. However, psychosocial factors seem to have a greater impact on QoL in PsA than in axSpA