Survey of adolescents' needs and parents' views on sexual health in juvenile idiopathic arthritis.

BACKGROUND: Although the advent of new therapeutics for juvenile idiopathic arthritis (JIA) patients has considerably lessened the impact of the disease and reduced its sequelae, the outcomes of JIA remain important in their lives. Disease repercussions and side effects of treatments may affect sexual health and cause psychological distress. This aim of the study was to determine the expectations of adolescent JIA patients and the perceptions of their parents regarding knowledge and communication with healthcare providers (HCPs) in the field of sexual health (SH). METHODS: In France, from September 2021 to April 2022, a survey was conducted, using anonymous self-administered questionnaires, among JIA patients (adults (aged 18-45 years) to provide insights from their recollection of their adolescence) and their parents in nine rheumatology centers and three patient associations. RESULTS: The responses to the 76 patient questionnaires and 43 parent questionnaires that were collected were analyzed. Half of the patients thought JIA impacted their romantic relationships, but the results were less clear-cut for their sexual activity; and 58.7% of the patients said they would be comfortable discussing the subject with HCPs, but only 26.3% had done so, mainly regarding biomedical issues. The patients and their parents thought that ideally, the topic should be addressed in an individual patient education session at the hospital (51.3% and 34.9%, respectively), in a regular consultation (47.4% and 53.5%), or in a dedicated consultation requested by the adolescent without the adolescent's parents being informed (38.2% and 20.9%). Most of the respondents thought HCPs should be proactive in SH (77.6% of the patients and 69.8% of their parents). More patients than parents said the following digital information tools must be used: videos (29.0% vs. 9.3%, p = 0.0127) and smartphone applications (25.0% vs. 9.3%, p = 0.0372). CONCLUSION: HCPs should consider addressing the unmet need for SH discussions during their patient encounters. To meet this need, we propose concrete actions in line with the wishes of patients and parents. CLINICAL TRIAL REGISTRATION NUMBER: NCT04791189.

Development and validation of a self-administered questionnaire measuring essential knowledge in patients with rheumatoid arthritis.

To develop and validate a questionnaire assessing patient knowledge in rheumatoid arthritis (RA). Knowledge considered essential for patients with RA was identified through a series of Delphi rounds among rheumatologists, health professionals (HPs), patients, and then reformulated to construct the knowledge questionnaire. Cross-sectional multicenter validation was performed in 12 rheumatology departments to assess internal validity (Kuder-Richardson coefficient), external validity, acceptability, reproducibility (Lin's concordance correlation coefficient) and sensitivity to change (difference in total score before and after patient education sessions). Associations between patient variables and knowledge levels were evaluated. RAKE (RA Knowledge questionnairE) is a self-administered 45-item questionnaire scored 0-100, with a 32-item short-form survey assessing knowledge of disease, comorbidity, pharmacological treatments, non-pharmacological treatments, self-care and adaptative skills. Of 130 patients included in the validation study, 108 were women. Acceptability was good with < 5% missing data. Internal validity coefficient was 0.90. Mean (standard deviation) long-form score was 72.8 ± 17.8, with lower scores in comorbidity and self-care and higher scores in adaptive skills. Reproducibility was good (0.86 [0.80; 0.92]). RAKE score was positively correlated with the patients' level of education and the HPs' opinion on the patients' knowledge. RAKE score showed good sensitivity to change: 66.8 ± 16.4 then 83.8 ± 12.7, representing a hedges effect size of 1.14 [95% CI 0.73; 1.55]. RAKE is an updated questionnaire assessing essential knowledge for patients with RA to enhance self-management according to current guidelines and the patients' perspective. RAKE can usefully inform patient education interventions, routine care and research.

Patients and spouses coping with inflammatory arthritis: Impact of communication and spousal perceived social support and burden.

OBJECTIVES: To guide Therapeutic Patient Education (TPE) programs to improve patients' and spouses' perceived health, we aimed to analyze the effect of the spouse health state and patient-spouse relationship on functional impairment, mental health and self-efficacy of patients with RA or SpA. METHODS: In this observational cross-sectional study, inclusion criteria were age≥18years and diagnosis of RA or SpA. The outcome criteria were functional impairment and mental health measured by the Medical Outcomes Study Short-Form 12-item version (SF-12-MCS); mental health measured by the General Health Questionnaire (GHQ-12); and self-efficacy by the General Self-Efficacy Scale (GSE Scale). Caregiver-patient relationship was assessed by the Personal Assessment of Intimacy in Relationships (PAIR) questionnaire and the Dyadic Adjustment Scale (DAS); social support by the Social Support Questionnaire-6 and spousal burden by the Zarit questionnaire. RESULTS: A total of 88 patient-spouse couples were included. Patients were mostly female (n=68, 77%), with mean age 59 (SD 12.6) years; 69% had RA. On bivariate analyses, only spousal burden was associated with patients' functional impairment. Patients' mental health was associated with satisfaction with social support and the dyad relationship. Self-efficacy of patients was associated with spousal burden, satisfaction with social support, spousal anxiety/depression and the dyad relationship. On multivariate analysis, improved mental health and perceived self-efficacy of patients were associated with spousal satisfaction with social support (Beta=0.8, P=0.1 with GHQ-12) good communication in the couple (Beta=0.5, P=0.04 with SF-12-MCS and Beta=0.4, P=0.04 with GSE Scale) and low spousal-assessed burden (Beta=-0.2, P=0.003 with GSE Scale). CONCLUSION: This study has identified potential focus for intervention. It has highlighted the importance of recognizing the role of couple communication (experiencing an open and fluent exchange of ideas) in the patient's mental health and self-efficacy but also perceived satisfaction with social support of both members of the couple on the patient's mental health.

Preconceived notions about biosimilars-a French experience.

Since the arrival of the first biosimilar monoclonal antibodies into the market, many information has been circulating, leading to preconceived notions for patients and healthcare professionals. In a pressing economic context and faced with a growing number of available biosimilars, we (clinician, patient association, biologist, pharmacists, health economists) propose to take stock by trying to distinguish facts from misconceptions.

Essential knowledge for patients with rheumatoid arthritis or spondyloarthritis: Results of a multicentric survey in France among health professionals and patients.

OBJECTIVE: Information and education are recommended for patients with inflammatory arthritis including rheumatoid arthritis (RA) and spondyloarthritis (SpA). However, there is no consensus on which knowledge is essential to enhance patients' self-management. The aim of this study was to determine such knowledge. METHODS: Based on published knowledge questionnaires (KQs) collected by a systematic literature review, a list of items was elaborated, classified in domains and sub domains. A Delphi process was performed with rheumatologists, healthcare professionals and patients in 2014-2015, selecting the items considered useful. RESULTS: Three published KQs were analysed: 2 for RA; 1 for SpA and 5 unpublished KQs were collected. In the KQs, 90 knowledge items were mentioned for RA and 67 for SpA. The 1st Delphi round enlarged the list to 322 items for RA and 265 items for SpA. The second round selected 69 and 59 knowledge items for RA and SpA respectively, of which 36 (52%) and 34 (57%) were not present or modified from the published KQs. Key domains included treatment strategies, managing cDMARDs and bDMARDs, managing symptomatic medications. Knowledge on non-pharmacological treatment concerned pain and fatigue, physical activity, adaptative skills to personal and professional environment, patient-HP communication and shared decision-making. CONCLUSION: The present study provides a corpus of knowledge considered essential for patients in the self-management of their arthritis. The selection of many items reflects recent emphasis on professional recommendations and the patients' perspective. Future work should lead to the development of new updated KQs for patients with inflammatory arthritis.

Patients' information and perspectives on biosimilars in rheumatology: A French nation-wide survey.

OBJECTIVE: To assess the patients' information about biosimilars and to identify the patients' incentives and deterrents to concur with the use of biosimilars. METHODS: Nation-wide cross-sectional study assessing information and concerns about biosimilars of French patients treated for rheumatic inflammatory diseases, whether they were treated or not by a biological DMARD. The assessment was available online from March to July 2017. RESULTS: Among the 629 respondents, 43% knew what biosimilars were. The main sources of information were rheumatologists and patient associations. Among patients treated with a biosimilar, 44% were not informed before they received the treatment. The patients' concerns focused on the non-similar molecular structure (46%), efficacy (60%) and safety (57%) comparatively to the originator biologic. 15% of respondents would refuse to switch their biologic to its biosimilar. More than 50% of respondents would warily accept to switch medications and interrupt the treatment if in doubt. Being informed about biosimilars and a good understanding of the definition of biosimilars were characteristics associated with better adherence to biosimilars. The rheumatologist was considered the most influent source of information about biosimilars and was considered reliable when deciding to switch a biologic to its biosimilar. Patient were reluctant to substitution of the medications by pharmacists (2%). Medico-economical issues acted as an incentive and a deterrent to accept the switch of medication. CONCLUSION: Biosimilars are largely unknown to patients. Information seems to be instrumental in improving the patients' adherence to biosimilars and could help preserving the therapeutic relationship and avoiding a nocebo effect.

Relevance and feasibility of a systematic screening of multimorbidities in patients with chronic inflammatory rheumatic diseases.

OBJECTIVES: EULAR recently proposed to screen multimorbidities in chronic inflammatory rheumatic diseases. The aims of the study were to define the most common multimorbidities in chronic inflammatory rheumatic diseases, compare the screening approach performed in the clinic with the recent EULAR recommendations, validate the points to consider for the systematic standardized multimorbidity screening proposed by EULAR and assess feasibility of such a screening in a daily clinic. METHODS: Data were collected prospectively during a 1-day multimorbidity clinic. Diabetes, hypertension, CVD damage, chronic respiratory diseases, osteoporosis and preventive measures were assessed. The comparison with EULAR points to consider was performed retrospectively. RESULTS: We included 200 consecutive patients (157 with rheumatoid arthritis, 37 spondyloarthritis, and 6 connective tissue diseases or vasculitis). The most common multimorbidities already diagnosed in our patients were hypertension (26%) and diabetes (7.5%). Screening showed that 61.5% (CI95%: 54.6%-67.9%) patients presented at least one undiagnosed or uncontrolled diseases: diabetes (6%), hypertension (20.6%), dyslipidemia (16.1%) valvulopathies (16.8%), peripheral artery disease (4.5%); carotid stenosis (6.5%) and aortic aneurysm (5.5%). Overall, 39.9% patients had incomplete cancer screening and 52.8% incomplete vaccine schedule. Undiagnosed pulmonary obstruction and risk of sleep apnea were suspected in 15.5% and 40.1% patients, respectively. CONCLUSION: This study underlines the relevance of a systematic screening of multimorbidities in chronic inflammatory rheumatic diseases and its feasibility in a 1-day clinic. Spirometry and sleep apnea screening should be added to EULAR points to consider. The long-term impact of such screening needs to be evaluated.

Hidradenitis suppurativa (HS): An unrecognized paradoxical effect of biologic agents (BA) used in chronic inflammatory diseases.

BACKGROUND: Paradoxical hidradenitis suppurativa (HS) induced by biologic agents (BA) is scarcely reported. OBJECTIVE: We sought to describe the clinical characteristics and outcome of patients developing paradoxical HS under BA. METHODS: This was a multicenter nationwide retrospective study asking physicians to report all cases of HS, confirmed by a dermatologist, occurring during treatment of an inflammatory disease by a BA. RESULTS: We included 25 patients (15 inflammatory rheumatism, 9 Crohn's disease, 1 psoriasis) treated by 5 BA (adalimumab = 12, infliximab = 6, etanercept = 4, rituximab = 2, tocilizumab = 1). Median duration of BA exposure before HS onset was 12 (range 1-120) months. Patients were mostly Hurley stage I (n = 13) or II (n = 11). Simultaneously to HS or within 1 year, 11 patients developed additional inflammatory diseases, including paradoxical reactions (psoriasis = 9, Crohn's disease = 3, alopecia areata = 1, erythema elevatum diutinum = 1). Complete improvement of HS was more frequently obtained after BA discontinuation or switch (n = 6/10, 60%) rather than maintenance (n = 1/14, 7%). Reintroducing the same BA resulted in HS relapse in 3 of 3 patients. LIMITATIONS: Retrospective nature and lack of complete follow-up for some patients are limitations. CONCLUSION: HS is a rare paradoxical adverse effect of BA, but fortuitous association cannot be excluded in some cases. We observed a trend toward better outcome when the BA was discontinued or switched.

Medico-economic evaluation of infliximab in rheumatoid arthritis--prospective French study of a cohort of 635 patients monitored for two years.

OBJECTIVES: To perform, in real conditions of prescription, the medico-economic evaluation of infliximab in severe RA. METHODS: A cost-effectiveness analysis of the annual costs was done with a comparison between the previous and the following year under infliximab. The effectiveness, determined from the HAQ, was expressed in clinically significant units and in quality-adjusted life years (QALYs). The incremental net benefit (INB), defined as willingness to pay (lambda), was used to express the results. RESULTS: A cohort of 635 patients was formed. Before the use of infliximab, after 1 and 2 years, the mean annual cost per patient for the care of RA was 9832, 27,723 and 46,704 euro, respectively. Among the direct costs, infliximab accounts for 21,182 euro for the first year. The distribution of the different costs was similar after 2 years. By using the INB, the difference before and after 1 year under infliximab is significant, on average by 1.86 (S.E.M. = 0.76) when the effectiveness is expressed in clinically significant units. For severe HAQ, lambda is 9841 euro (18,593 for all HAQ). When it is expressed in QALYs, also for severe HAQ, lambda > 100,000 euro. This can be explained by a short follow-up although severe complication of RA appears later. CONCLUSION: An evaluation of the more long-term costs is required in order to determine whether there are any full economic benefits with this treatment.

Psoriasis induced by tumor necrosis factor-alpha antagonist therapy: a case series.

OBJECTIVE: Although tumor necrosis factor-alpha (TNF-alpha) antagonists are effective in the treatment of refractory psoriasis, some cases have suggested that psoriasis might be induced as a result of treatment prescribed mainly for rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. To investigate anti-TNF-alpha induced psoriasis, we conducted a systematic analysis of the 6 cases we observed among our inflammatory patient cohort treated with anti-TNF-alpha (infliximab or etanercept). METHODS: We report 6 cases of psoriasis with onset during TNF-alpha antagonist therapy (infliximab and etanercept); characteristics and skin lesions are described. RESULTS: No patient had a personal or family history of psoriasis. The development of psoriasis was seen in all the types of inflammatory diseases we treated with TNF-alpha antagonists. There was great variation in the age of affected patients and in the onset of psoriasis after initiation of TNF-alpha antagonists. Both TNF-alpha antagonists studied were associated with development of psoriasis. In 2 cases psoriasis was associated with 2 different TNF-alpha antagonists in the same patient. In half our patients, skin lesions started in the inguinal and pubic regions, but palmoplantar pustulosis was also common. In half the cases, skin lesions responded favorably with topical agents despite continuation of TNF-alpha antagonist therapy. CONCLUSION: In light of previously published cases describing psoriasis or psoriasiform lesions after TNF-alpha antagonist therapy, our series strongly confirms that TNF-alpha antagonists may induce psoriasis in some patients. Further studies are needed to identify risk factors for TNF-alpha antagonist induced psoriasis.

Health assessment questionnaire score is the best predictor of 5-year quality of life in early rheumatoid arthritis.

OBJECTIVE: To evaluate and determine prognostic factors of 5-year quality of life in patients with early rheumatoid arthritis (RA). METHODS: A cohort of 191 patients with RA and disease duration < 1 year was prospectively followed over 5 years. The outcome measure was quality of life as assessed by the Arthritis Impact Measurement Scales 2 (AIMS2). Univariate analysis, then stepwise multiple logistic regression, was used to find independent baseline prognostic variables. RESULTS: After accounting for death, loss of followup, and missing data, 158 patients (82.72%) were included in the analysis. The mean AIMS2 physical, symptom, psychological, social interaction, and work scores after 5 years were 1.6 (range 0-6.88), 4.0 (0-10), 3.48 (0-9.22), 4.06 (0-8.69), and 1.87 (0-8.13), respectively. The AIMS2 physical component was significantly correlated with Health Assessment Questionnaire (HAQ) score at 5 years. Logistic regression analysis revealed that the baseline values able to predict the 5-year physical, psychological, symptom, social interaction, and work status were, respectively: HAQ score and erythrocyte sedimentation rate (ESR), body mass index (BMI), HAQ; erosion score and sex, HAQ; ESR and anti-perinuclear antibody; matrix metalloproteinase-3 (MMP3) level, joint space narrowing, and tender joint scores; HAQ score and age. CONCLUSION: The multidimensional structure of the AIMS2 allowed us to assess the 5-year health-related quality of life in early RA. Using this instrument as an outcome variable, prognostic factors were selected and varied widely depending on the evaluated domain. The baseline HAQ score was the best predictive factor of 4 of the 5 domains of the AIMS2.

[Anti-TNF alpha in the treatment of psoriatic arthritis]. / Anti-TNF alpha dans le traitement du rhumatisme psoriasique.

Psoriatic arthritis is an inflammatory and possibly destructive form of arthritis. As in rheumatoid arthritis and ankylosing spondylitis, the use of biological therapy in psoriatic arthritis is a therapeutic revolution: both articular and cutaneous efficacy have been shown, and some improvement is visible on radiography. The benefit-risk ratio will improve when we learn to identify more accurately the patients likely to benefit from these treatments.

Estimation of the Bath Ankylosing Spondylitis Disease Activity Index cutoff for perceived symptom relief in patients with spondyloarthropathies.

OBJECTIVE: To estimate the best Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) cutoff based on patients' perceptions of symptom relief collected in a large population of patients with spondyloarthropathies (SpA), in comparison to the BASDAI cutoff determined by experts. METHODS: A survey of patient perceptions about current disease control was conducted among the members of Spondylis, one of the main not-for-profit SpA patient organizations in France. BASDAI was among data collected by the questionnaire. To estimate the best BASDAI cutoff for discriminating between poor and well perceived controlled groups, we plotted the receiver operating characteristic (ROC) curve. We also determined the cutoff separately in male and female patients. RESULTS: Of the 1000 mailed questionnaires, 485 were returned without any missing data regarding perceived disease control and the BASDAI. Of these patients, 55.3% perceived inadequate control of their disease. The mean BASDAI in the overall population was 43.5 +/- 22.9, 30.4 +/- 19.9 in the well controlled group and 54 +/- 19.4 in the poorly controlled group (p < 0.001). The best BASDAI cutoff for discriminating between patients in the 2 groups was 39 (sensitivity 74.6% and specificity 72.4%). According to gender, the best cutoff was 44 for women and 36 for men. CONCLUSION: The best BASDAI cutoff of 39 based on patients' perceptions was very similar to that selected by international experts, i.e., 40. Gender affected the cutoff for perceived symptom relief in our study. These results need to be confirmed by further studies collecting the opinions of both patients and physicians.