The effect of a goal-setting strategy with integrated feedback on goal attainment in inflammatory arthritis patients:a mixed method study

Patients with Inflammatory Arthritis (IA) often experience difficulties in daily life as a result of their disease. Unfortunately, outpatient consultations in daily practice tend to focus on medical topics, thereby ignoring the impact of the disease on patients’ daily lives. Patient-Reported Outcomes (PROs) can be used to understand this impact, but they are not enough for offering person-centered care. Because the patient’s true values and goals can only be ascertained during a proper conversation, which should include both medical as well as patient goals. Therefore, the aim of the study is to evaluate the effect of a goal management strategy with integrated feedback on goal attainment and Health-Related Quality of Life(HRQoL) in IA patients. IA patients with an active disease were given the opportunity to set and follow-up goals. In addition to goal setting, patients were asked to complete online questionnaires on various PROs, including HRQoL. Ninety-two IA patients participated in the study. The mean age was 51 years and most of them had rheumatoid arthritis. A total of 302 patient goals were set, of which 32% were achieved. In the entire population, HRQoL did not change over time, but patients who did not meet their goals tended to report a lower HRQoL. Incorporating a feedback mechanism in a goal-setting strategy has a positive effect on goal attainment. Yet no effect was seen on HRQoL, but this may due to the fact that general HRQoL measurement are not sensitive or specific enough to detect changes that are accompanied with goal setting and attainment.</p

Subfertility in Women With Rheumatoid Arthritis and the Outcome of Fertility Assessments

_Objective:_ Subfertility is frequently encountered among female rheumatoid arthritis (RA) patients and has been associated with disease activity and antirheumatic drugs. However, little is known about the results of the fertility assessments in these women. Our aim was to study the outcome of fertility assessments in subfer

The pre- and post-authorisation data published by the European Medicines Agency on the use of Biologics during pregnancy and lactation

Aims: The effects of biologics on reproduction/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and comparison of initial and post-authorization data. Methods: Initial and post-authorization data were extracted from the European Public Assessment Reports and the latest versions of Summary of Product Characteristics using publicly available documents on the European Medicines Agency's website. Four sections were categorized regarding pregnancy outcomes: pre-clinical/animal studies, human female fertility, pregnancy-related outcomes and congenital malformations in the human fetus. Three sections were categorized regarding lactation outcomes: pre-clinical/animal studies, excretion in human breast milk and absorption in children through breastfeeding. The clinical applicability of each category was scored by specified criteria, based on scientific literature, and further as defined by the authors. Results: For the 16 included biologics, post-authorization data were delivered only for adalimumab, certolizumab pegol, etanercept and infliximab. For the 12 remaining biologics limited data on pregnancy and lactation during the post-marketing period of 2–21 years were available. Conclusions: In this article several suggestions are provided for improving a multidisciplinary approach to these issues. The initiation of suitable registries by marketing authorization holders and data transparency for clinicians and academics are highly endorsed

Determinants of radiographic progression in early psoriatic arthritis:Insights from a real-world cohort

Objective Persistent articular inflammation in psoriatic arthritis (PsA) is associated with radiographic damage. Despite advances in diagnosis and therapy, radiographic structural damage remains prevalent in PsA. To elucidate this topic, we studied which baseline clinical characteristics determine radiographic progression. Methods For this analysis, data were used from DEPAR (Dutch South West Psoriatic Arthritis) Study, a real-world cohort of patients with newly diagnosed PsA. Radiographic changes were assessed using the modified Total Sharp/van der Heijde Score (mTSS) for PsA. Univariable-multivariable mixed-effects negative binomial regression analysis was applied to define baseline predictors for radiographic progression over time. Results The study included 476 patients with early PsA with 1660 hand and feet radiographs from four different time points (baseline, first, second and third year). The progressive group (n=71) had a higher mTSS compared with the non-progressive group (n=405) at diagnosis (17 (3-36) vs 0 (0-1)). A comparison of the two groups revealed that the progressive group had significantly older (59 (12) vs 49 (13)) and a higher rate of the presence of swollen joints (93% vs 78%) at diagnosis. Multivariable analysis identified age (incidence rate ratio (IRR)=1.10, p=0.000), sex (female) (IRR=0.48, p=0.043) and baseline mTSS (IRR=1.11, p=0.000) as significant determinants of radiographic change over time. For the progressive subset, additionally, the multivariable analysis highlighted baseline Disease Activity in PSoriatic Arthritis (IRR=1.05, p=0.006) and swollen joint count (IRR=1.07, p=0.034) as predictors. Conclusions According to this real-world cohort, patients with early PsA exhibit minimal radiographic progression under current treatment protocols. This study indicates that while old age and initial radiographic damage predict progression, female sex confers a protective effect on it. Furthermore, disease activity score and swollen joints emerged as predictors for radiographic changes during the follow-up in progressive patients.</p

Determinants of radiographic progression in early psoriatic arthritis:Insights from a real-world cohort

Objective Persistent articular inflammation in psoriatic arthritis (PsA) is associated with radiographic damage. Despite advances in diagnosis and therapy, radiographic structural damage remains prevalent in PsA. To elucidate this topic, we studied which baseline clinical characteristics determine radiographic progression. Methods For this analysis, data were used from DEPAR (Dutch South West Psoriatic Arthritis) Study, a real-world cohort of patients with newly diagnosed PsA. Radiographic changes were assessed using the modified Total Sharp/van der Heijde Score (mTSS) for PsA. Univariable-multivariable mixed-effects negative binomial regression analysis was applied to define baseline predictors for radiographic progression over time. Results The study included 476 patients with early PsA with 1660 hand and feet radiographs from four different time points (baseline, first, second and third year). The progressive group (n=71) had a higher mTSS compared with the non-progressive group (n=405) at diagnosis (17 (3-36) vs 0 (0-1)). A comparison of the two groups revealed that the progressive group had significantly older (59 (12) vs 49 (13)) and a higher rate of the presence of swollen joints (93% vs 78%) at diagnosis. Multivariable analysis identified age (incidence rate ratio (IRR)=1.10, p=0.000), sex (female) (IRR=0.48, p=0.043) and baseline mTSS (IRR=1.11, p=0.000) as significant determinants of radiographic change over time. For the progressive subset, additionally, the multivariable analysis highlighted baseline Disease Activity in PSoriatic Arthritis (IRR=1.05, p=0.006) and swollen joint count (IRR=1.07, p=0.034) as predictors. Conclusions According to this real-world cohort, patients with early PsA exhibit minimal radiographic progression under current treatment protocols. This study indicates that while old age and initial radiographic damage predict progression, female sex confers a protective effect on it. Furthermore, disease activity score and swollen joints emerged as predictors for radiographic changes during the follow-up in progressive patients.</p

Pregnancy-associated serum N-glycome changes studied by high-throughput MALDI-TOF-MS

Pregnancy requires partial suppression of the immune system to ensure maternal-foetal tolerance. Protein glycosylation, and especially terminal sialic acid linkages, are of prime importance in regulating the pro- and anti-inflammatory immune responses. However, little is known about pregnancy-associated changes of the serum N-glycome and sialic acid linkages. Using a combination of recently developed methods, i.e. derivatisation that allows the distinction between α2,3- and α2,6-linked sialic acids by high-throughput MALDI-TOF-MS and software-assisted data processing, we analysed the serum N-glycome of a cohort of 29 healthy women at 6 time points during and after pregnancy. A total of 77 N-glycans were followed over time, confirming in part previous findings while also revealing novel associations (e.g. an increase of FA2BG1S1(6), FA2G1S1(6) and A2BG2S2(6) with delivery). From the individual glycans we calculated 42 derived traits. With these, an increase during pregnancy and decrease after delivery was observed for both α2,3- and α2,6-linked sialylation. Additionally, a difference in the recovery speed after delivery was observed for α2,3- and α2,6-linked sialylation of triantennary glycans. In conclusion, our new high-throughput workflow allowed the identification of novel plasma glycosylation changes with pregnancy

Paternal inflammatory arthritis is associated with a higher risk of miscarriage:results of a large multicentre study (iFAME-Fertility)

OBJECTIVES: Paternal preconception health is recognized as an important contributor to pregnancy outcomes. Nonetheless, pregnancy outcomes of partners of men with inflammatory arthritis (IA) have never been studied. Our objective was to describe the pregnancy outcomes of partners of men diagnosed with IA.METHODS: We performed a multicentre cross-sectional retrospective study conducted in the Netherlands. Men with IA who were over 40 years old that reported at least one positive pregnancy test were included. To analyse the impact of IA on pregnancy outcomes, pregnancies were classified into two groups: pregnancies conceived after the diagnosis of IA and before the diagnosis of IA.RESULTS: In total, 408 male participants diagnosed with IA reported 897 singleton pregnancies that resulted in 794 live births. Pregnancies conceived after the diagnosis of IA had higher rate of miscarriage (12.27 vs 7.53%, P = &lt;0.05). This increased risk was still present after adjusting for confounders [OR 2.03 (95% CI 1.12, 3.69) P = 0.015].CONCLUSIONS: This is the largest study to describe the pregnancy outcomes of partners of men diagnosed with IA and the first to demonstrate that paternal IA is associated with a higher risk of miscarriage. Notwithstanding, the overall rate of miscarriage reported in our study could be comparable to previously reported population estimates.</p

Is methotrexate safe for men with an immune-mediated inflammatory disease and an active desire to become a father? Results of a prospective cohort study (iFAME-MTX)

Introduction Current scientific evidence guiding the decision whether men with an active desire to become a father should be treated with methotrexate (MTX) remains controversial. We aimed to prospectively evaluate the testicular toxicity profile of MTX focusing on several markers of male fertility, including semen parameters and sperm DNA fragmentation index (sDFI). As a secondary outcome, we aimed to evaluate whether MTX-polyglutamates can be detected in spermatozoa and seminal plasma and to evaluate the enzymatic activity in spermatozoa of folylpolyglutamate synthetase (FPGS). Methods In a prospective cohort study, men ≥18 years who started therapy with MTX were invited to participate (MTX-starters). Participants were instructed to produce two semen samples (a pre-exposure and a post-exposure sample after 13 weeks). Healthy men ≥18 years were invited to participate as controls. Conventional semen analyses, male reproductive endocrine axis and sDFI were compared between groups. FPGS enzymatic activity and MTX-PG1-5 concentrations were determined by mass spectrometry analytical methods. Results In total, 20 MTX-starters and 25 controls were included. The pre-exposure and postexposure semen parameters of MTX-starters were not statistically significant different. Compared with healthy controls, the conventional semen parameters and the sDFI of MTX-starters were not statistically significant different. These data were corroborated by the marginal accumulation of MTX-PGs in spermatozoa, consistent with the very low FPGS enzymatic activity associated with the expression of an alternative FPGS splice-variant. Discussion Treatment with MTX is not associated with testicular toxicity, consistent with the very low concentration of intracellular MTX-PG. Therefore, therapy with MTX can be safely started or continued in men and with a wish to become a father.</p

Effects of childhood-onset systemic lupus erythematosus on academic achievements and employment in adult life

Objective. Long-term outcome data in adults with childhood-onset systemic lupus erythematosus (cSLE) are limited. Here, we report the effects of cSLE on education, vocation, and employment in a large cohort of adults with cSLE.Methods. Patients were seen for a single study visit comprising a structured history and physical examination. Medical records were retrieved to supplement information obtained during the study visit. Education and employment status were assessed by questionnaires. I Iealth-related quality of life (HRQOL) was measured with the 36-Item Short Form Health Survey (SF-36).Results. One hundred six patients with cSLE (93% female, 73% White), with a median disease duration of 20 years, completed the visit and questionnaires. Almost all patients stated that cSLE had influenced their education, but the level of completed education was similar to the general Dutch population. Half of the patients had adjusted their vocational choice due to the disease. Still, 44% of patients who had finished education did not have a paid job. Of the employed patients, 61% worked part time. Disease damage was equally prevalent in patients with and without paid employment. A high percentage of patients (51%) were declared work disabled, due to disease damage. Patients who did not have paid employment were often work disabled. Both had a negative effect on HRQOL.Conclusion. The effect of cSLE on academic achievements and employment is substantial, despite patients adjusting their educational and vocational choices. To optimize participation in the community, ongoing support is necessary, not only to help patients find suitable education and vocations but also to offer guidance regarding potential adjustments during their career.Nephrolog

Long-Term Clinical Outcomes in a Cohort of Adults With Childhood-Onset Systemic Lupus Erythematosus

Objective Childhood‐onset systemic lupus erythematosus (SLE) is a severe, lifelong, multisystem autoimmune disease. Long‐term outcome data are limited. This study was undertaken to identify clinical characteristics and health‐related quality of life (HRQoL) of adults with childhood‐onset SLE. Methods Patients participated in a single study visit comprising a structured history and physical examination. Disease activity (scored using the SLE Disease Activity Index 2000 [SLEDAI‐2K]), damage (scored using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index [SDI]), and HRQoL (scored using the Short Form 36 Health Survey) were assessed. Medical records were reviewed. Results In total, 111 childhood‐onset SLE patients were included; the median disease duration was 20 years, 91% of patients were female, and 72% were white. Disease activity was low (median SLEDAI‐2K score 4), and 71% of patients received prednisone, hydroxychloroquine (HCQ), and/or other disease‐modifying antirheumatic drugs. The vast majority of new childhood‐onset SLE–related manifestations developed within 2 years of diagnosis. Damage such as myocardial infarctions began occurring after 5 years. Most patients (62%) experienced damage, predominantly in the musculoskeletal, neuropsychiatric, and renal systems. Cerebrovascular accidents, renal transplants, replacement arthroplasties, and myocardial infarctions typically occurred at a young age (median age 20 years, 24 years, 34 years, and 39 years, respectively). Multivariate logistic regression analysis showed that damage accrual was associated with disease duration (odds ratio [OR] 1.15, P < 0.001), antiphospholipid antibody positivity (OR 3.56, P = 0.026), and hypertension (OR 3.21, P = 0.043). Current HCQ monotherapy was associated with an SDI score of 0 (OR 0.16, P = 0.009). In this cohort, HRQoL was impaired compared to the overall Dutch population. The presence of damage reduced HRQoL scores in 1 domain. High disease activity (SLEDAI‐2K score ≥8) and changes in physical appearance strongly reduced HRQoL scores (in 4 of 8 domains and 7 of 8 domains, respectively). Conclusio