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Le filgotinib a précédemment démontré une amélioration rapide avec des PRO significatifs à l'échelle du groupe. Cependant, on ne sait pas quelle proportion de patients s'est améliorée et si ces améliorations se maintiennent au niveau individuel. L'objectif de cette étude était d'évaluer le maintien de l'amélioration des PRO significatifs (douleur, fatigue et fonction physique) chez les patients atteints de PR recevant FIL 200 ou 100 mg (FIL200/100), de l'adalimumab ou un placebo. Cette analyse a évalué les données des essais de phase 3 FINCH 1 (NCT02889796) et FINCH 2 (NCT02873936). Dans FINCH 1, les patients présentant une réponse inadéquate (RI) au méthotrexate (MTX) ont reçu FIL200/100, ADA ou PBO, avec du MTX, pendant 52 semaines (52S). Dans FINCH 2, les patients présentant une RI à ≥ 1 médicament bDMARD ont reçu FIL200/100 ou PBO, avec des csDMARD, pendant 24S. Les proportions de patients répondant aux critères suivants ont été évaluées : « douleur limitée ou nulle » (échelle visuelle analogique EVA ≤ 10 mm), « état de santé non affecté négativement par la douleur » (EVA ≤ 20 mm), 4 évaluation fonctionnelle de la thérapie des maladies chroniques – fatigue (FACIT-F) (différence minimale cliniquement importante [MCID], changement par rapport à l'inclusion CFB ≥ 4) et un questionnaire d'évaluation de l'état de santé – indice d'invalidité (HAQ-DI) (MCID, CFB = –0,22 ou moins). La proportion de patients ayant obtenu une première réponse aux S2, 4, 12, 24 et 52 (52 pour FINCH 1), la durée de la réponse et ceux ayant maintenu leur réponse de S12 à S24 et S52 (52 pour FINCH 1) ont été rapportées par groupe de traitement. Dans l'ensemble, versus FIL100 ou PBO, une plus grande proportion de patients ayant reçu FIL200 ont d'abord obtenu une réponse pour l'ensemble des critères dans FINCH 1 et FINCH 2, à l'exception de FACIT-F avec FIL100, pour lequel les proportions étaient similaires. Dans FINCH 1, un plus grand nombre de patients sous FIL200 a atteint plus rapidement (S4) un état de « douleur limitée à nulle ». Dans FINCH 1, une plus grande proportion de patients recevant un traitement actif a obtenu plus rapidement le statut « douleur limitée à nulle » que ceux recevant le PBO, et une plus grande proportion de patients dans le bras FIL200 a atteint ces critères que dans les bras FIL100 ou ADA (Tableau 1). La durée de la réponse HAQ-DI dans FINCH 1 et FINCH 2 était similaire avec FIL200 et FIL100, et plus longue qu'avec ADA et PBO (Figure 1). À l'exception de FACIT-F, où les courbes FIL et ADA se sont chevauchées, une perte de réponse des PRO dans FINCH 1 et 2 a été observée jusqu'à S12 avant de se stabiliser. Avec FIL200, le premier statut « douleur limitée à nulle » a été atteint à la S12 et maintenu à la S52 chez 15,4 % des patients dans FINCH 1 (Tableau 1) et à la S24 chez 13,6 % des patients dans FINCH 2. Les proportions de patients recevant FIL200 avec des réponses « état de santé non affecté négativement par la douleur », FACIT-F et HAQ-DI maintenues, étaient respectivement de 29,7 %, 49,3 % et 64,4 % dans FINCH 1 (S52) et de 29,9 %, 55,8 % et 63,9 % dans FINCH 2 (S24). Cette analyse post hoc montre que les améliorations significatives des PRO avec FIL dans la PR, à l'échelle du patient, se produisent tôt et se maintiennent dans le temps. [ABSTRACT FROM AUTHOR]

Objectives: To update the long-term safety profile of filgotinib, a Janus kinase-1 preferential inhibitor, in patients with moderate-to-severe rheumatoid arthritis., Methods: Data from seven trials were integrated (NCT01888874, NCT01894516, NCT02889796, NCT02873936, NCT02886728, NCT02065700 and NCT03025308). Patients received once-daily filgotinib 100 mg or 200 mg. Exposure-adjusted incidence rates (EAIRs)/100 patient-years of exposure (PYE) were calculated for treatment-emergent adverse events (TEAEs). Post hoc analyses assessed patients aged <65 and ≥65 years., Results: Patients (N=3691) received filgotinib for a median (maximum) of 3.8 (8.3) years (12 541 PYE). Rates of TEAEs of interest: serious infections, malignancies, major adverse cardiovascular events (MACE) and venous thromboembolism were stable over time and comparable between doses. In the overall population, numerically lower EAIR (95% CI)/100 PYE of herpes zoster was observed for filgotinib 100 mg versus 200 mg (1.1 (0.8 to 1.5) vs 1.5 (1.2 to 1.8)). Incidence of serious infections, herpes zoster, MACE, malignancies and all-cause mortality was higher in patients aged ≥65 versus <65 years. In patients aged ≥65 years, EAIRs (95% CI)/100 PYE for non-melanoma skin cancer (NMSC) (0.4 (0.1 to 1.1) vs 1.4 (0.8 to 2.2)), malignancies excluding NMSC (1.0 (0.5 to 1.9) vs 2.0 (1.3 to 2.9)) and all-cause mortality (1.3 (0.7 to 2.2) vs 1.6 (1.0 to 2.5)) were numerically lower for filgotinib 100 mg versus 200 mg., Conclusions: In the overall population, TEAEs of interest were stable over time and similar between filgotinib 100 mg and 200 mg dose groups, except for herpes zoster. A dose-dependent relationship between malignancies and all-cause mortality was suggested in patients ≥65 years old., Competing Interests: Competing interests: GRB reports consultancy fees from AbbVie, Amgen, BMS, Galapagos, Lilly, Pfizer and Sanofi; and speakers’ bureau fees from AbbVie, Amgen, BMS, Chugai, Galapagos, Lilly, Pfizer and Sanofi. J-EG reports consultancy fees from AbbVie, BMS, Galapagos, Gilead, Lilly, MSD, Novartis and Pfizer; and grant/research support from BMS and Pfizer. RC reports consultancy fees from AbbVie, Fresenius, Galapagos, Lilly, Pfizer, Novartis and UCB; speakers’ bureau fees from AbbVie, Amgen, BMS, Celltrion, Fresenius, Galapagos, Janssen, Lilly, Novartis, Pfizer and UCB. KLW reports consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly & Company, Galapagos, Gilead, GSK, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB; and grant/research support from BMS and Pfizer. YT has received speaker fees and/or honoraria from AbbVie, Asahi Kasei, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Taiho, Taisho and Pfizer; and research grants from Asahi Kasei, Chugai, Eisai, Mitsubishi Tanabe and Taisho. EVEO is a consultant for Galapagos. VR is a former employee of, and shareholder in, Galapagos. PVH is a consultant for AOP Health, Aspen and Galapagos; and a previous employee of Janssen, MSD and Schering-Plough. KVB is an employee of, and shareholder in, Galapagos. TT reports consultancy fees from AbbVie GK, Astellas, Chugai, Eli Lilly Japan, Gilead, Janssen Pharma K.K., Mitsubishi Tanabe and Pfizer Japan; speakers’ bureau fees from AbbVie GK, AYUMI, BMS, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Gilead, Janssen Pharma K.K., Mitsubishi Tanabe, Pfizer Japan and Sanofi K.K.; and research/grant support from AbbVie GK, Asahi Kasei, Astellas, AYUMI, Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan, Mitsubishi Tanabe, Nippon Kayaku and UCB Japan. RW acted as an adviser and speaker for Celltrion, Galapagos and Gilead. DA reports consultancy fees, speakers’ bureau fees and grant/research support from AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Sandoz and Sanofi., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ on behalf of EULAR.)

Background: The interest in meat alternatives has increased over the years as people embrace more varied food choices because of different reasons. This study aims to analyse the nutritional composition of ready-to-use meat alternatives and compare them with meat (products)., Methods: Nutritional composition values were collected in 2022 of all ready-to-use meat alternatives in Belgian supermarkets, as well as their animal-based counterparts. A one-sample t -test was performed to test the nutritional composition of ready-to-use meat alternatives against norm values, while an independent samples t -test was used to make the comparison with meat., Results: Minced meat and pieces/strips/cubes scored favourably on all norm values. Cheeseburgers/schnitzels, nut/seed burgers and sausages contained more than 10 g/100 g total fat. The saturated fat and salt content was lower than the norm value in each category. Legume burgers/falafel contained less than 10 g/100 g protein. Vegetarian/vegan minced meat and bacon contained fewer calories, total and saturated fat, and more fibre compared to their animal-based counterparts., Conclusions: Minced meat and pieces/strips/cubes came out as the most favourable categories regarding nutritional composition norm values. Vegetarian/vegan steak came out the least favourable compared to steak, while vegetarian/vegan minced meat and vegetarian/vegan bacon came out the most favourable compared to their animal-based counterparts., Competing Interests: The authors declare no conflicts of interest.

Objective: Understanding preferences of patients with rheumatoid arthritis (RA) can facilitate tailored patient-centric care. This study elicited trade-offs that patients with RA were willing to make during treatment selection., Methods: Patients with RA completed an online discrete choice experiment, consisting of a series of choices between hypothetical treatments. Treatment attributes were selected based on literature review and qualitative patient interviews. Eligible patients were ≥18 years old, diagnosed with RA, receiving systemic disease-modifying antirheumatic drug therapy, and residents of Europe or USA. Male patients were oversampled for subgroup analyses. Data were analysed using a correlated mixed logit model., Results: Of 2090 participants, 42% were female; mean age was 45.2 years (range 18-83). Estimated effects were significant for all attributes (p<0.001) but varied between patients. Average relative attribute importance scores revealed different priorities (p<0.001) between males and females. While reducing pain and negative effect on semen parameters was most important to males, females were most concerned by risk of blood clots and serious infections. No single attribute explained treatment preferences by more than 30%. Preferences were also affected by patients' age: patients aged 18-44 years placed less importance on frequency and mode of treatment administration (p<0.05) than older age groups. Patients were willing to accept higher risk of serious infections and blood clots in exchange for improvements in pain, daily activities or administration convenience. However, acceptable trade-offs varied between patients (p<0.05)., Conclusion: Treatment preferences of patients with RA were individual-specific, but driven by benefits and risks, with no single attribute dominating the decision-making., Competing Interests: Competing interests: RA, consultancy fees from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celltrion, Gilead, Janssen, Lilly, Medac, MSD, Mylan, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, UCB, VIATRIS. JCNG, consultancy fees from Lilly, Janssen, Amgen, GSK, AbbVie, Galápagos, MSD; speakers fees from MSD, Pfizer, BMS, AbbVie, UCB Pharma, Janssen, Lilly, Faes Farma, Roche, Celgene, Sanofi, Nordic Pharma, Gebro, Novartis, Biogen, Amgen, Sandoz. PJ, grants support from Pfizer and Roche; speakers fees from Eli Lilly; support for meeting attendance from Galapagos. CM, consultancy fees from BMS, AbbVie, Gilead; speakers fees from BMS, AbbVie, Eli Lilly, Pfizer, Boehringer, Galapagos, Sanofi, Roche. RM, grant support from Novartis; consultancy fees from Ferring; speakers fees from Amgen and Galapagos. HR, speakers fees from Gilead Science, Merck Sharp; Pfizer Cooperation Austria, Janssen. HEV, grants from Galapagos, Boehringer Ingelheim; speakers fees from Galapagos, AbbVie, Boehringer Ingelheim, Novartis, Pfizer, UCB, Janssen. SH, employee of Evidera Inc, which is part of Thermo Fisher Scientific's Clinical Research Group; Evidera received payment for conducting the work outlined in this manuscript; SH is a minority stockholder of Thermo Fisher Scientific, as part of his employment with Evidera. CW, employee of Evidera Inc, which is part of Thermo Fisher Scientific's Clinical Research Group; Evidera received payment for conducting the work outlined in this manuscript. NK, employee of Evidera Inc, which is part of Thermo Fisher Scientific's Clinical Research Group; Evidera received payment for conducting the work outlined in this manuscript; NK is a minority stockholder of Thermo Fisher Scientific, as part of his employment with Evidera. KVB, employee and shareholder of Galapagos NV., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: We aimed to describe, from the perspective of rheumatologists in Europe, how the coronavirus disease 2019 (COVID-19) pandemic has impacted their management of people with RA and the continuing medical education of physicians., Methods: Rheumatologists participating in the Adelphi RA Disease Specific Programme TM in six European countries were contacted in August and September 2020 for a telephone survey. Rheumatologists were asked seven attitudinal questions on changes to patient management, prescription behaviour and continuing education owing to COVID-19. Results were summarized with descriptive statistics., Results: The telephone survey was completed by 284 rheumatologists. The most commonly reported changes to patient management were increased utilization of video/telephone consultations (66.5% of respondents), fewer visits (58.5%) and limiting physical contact (58.1%). Furthermore, 67.9% of rheumatologists who indicated that prescribing behaviour had changed switched their patients to self-administered medication, and 60.7% reported not starting patients on targeted synthetic DMARDs, biologic originator DMARDs or biosimilar DMARDs. In total, 57.6% of rheumatologists believed that changes in management would persist. Rheumatologists reported that 38.0% of patients expressed concerns about how COVID-19 would impact treatment, including access to treatment and the risk of infection. The biggest impact on rheumatologist education was a switch to online training and conferences., Conclusion: All countries saw changes in patient management and prescribing behaviour, including the rapid uptake of telemedicine. It is important that the international rheumatology community learns from these experiences to prepare better for future pandemics and to address ongoing rheumatologist shortages., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Background: While treat-to-target (T2T) is endorsed for the management of rheumatoid arthritis (RA), data on the degree of implementation in clinical practice are limited. This study investigated the use of T2T for RA in a real-world setting across Europe., Methods: The Adelphi RA Disease-Specific Programme was a point-in-time survey of rheumatologists and their consulting patients with RA conducted between January and October 2020 in Belgium, France, Germany, Italy, Spain and the UK. Rheumatologists completed an attitudinal survey, and a record form for their next 10-12 consulting patients, who were invited to voluntarily complete a patient-reported questionnaire. Data collected included clinical characteristics, treatment patterns and attitudes towards T2T., Results: Overall, 316 rheumatologists provided data for 3120 patients, of whom 1108 completed the questionnaire. While 86.1% of rheumatologists estimated using T2T principles in clinical practice, only 66.6% of patients were reported by their physician to be managed using a T2T approach. Achieving disease remission was the most commonly reported treatment goal identified by rheumatologists (79.7%), followed by symptom control (47.8%) and reducing impact on quality of life (44.5%). 40.8% of rheumatologists and their patients were in agreement that a treatment goal had been set. When there was agreement on treatment goals, we observed better patient satisfaction, engagement and treatment success., Conclusions: Despite recommendations, the T2T approach in RA appears to be suboptimally implemented in clinical practice. This highlights the importance of patient-centricity in the decision-making process to define meaningful targets and select appropriate treatments to improve disease outcomes., Competing Interests: Competing interests: PCT has received research grants and/or consultation fees from Galapagos, AbbVie, Biogen, Gilead, GlaxoSmithKline, Janssen, Novartis, Lilly, Pfizer, Roche, Sanofi, Nordic Pharma, Fresenius and UCB. BF has received research grants from AbbVie, Lilly, MSD and Pfizer, and consultancy fees from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Fresenius Kabi, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, Sobi and UCB. YP has received consultancy fees from AbbVie, Galapagos, Grünenthal, Lilly, Novartis, Janssen and Sandoz. SR-Y has been paid as a speaker by AbbVie, Amgen, Bristol Myers Squibb, Grunenthal, Janssen, Kern Pharma, Lilly, Roche, Sandoz, Sanofi and UCB; been a paid consultant for AbbVie, Bristol, Biogen, Fresenius, Galapagos, Gebro, Janssen and Lilly; and received grant/research support from Bristol Myers Squibb, MSD, Novartis and Pfizer. JB has received consultancy fees from Galapagos, Gilead, Novartis, Astra Zeneca and UCB. MW has received research support from AbbVie, Actelion, Boehringer, Galapagos, Gilead, GSK, Hexal, Novartis and UCB; consultancy fees from AbbVie, Boehringer, BMS, Celgene, Galapagos, Gilead, GSK, Medac, Mylan, Novartis, Pfizer, Sanofi and UCB; and speaker fees from AbbVie, Aescu, Amgen, Biogen, BMS, Berlin Chemie, GSK, Hexal, Janssen, Medac, MSD, Mundipharma, Mylan, Novartis, Pfizer, Riemser, Sanofi and UCB. OH is an employee of Adelphi Real World. ER is an employee of Adelphi Real World. MZ is an employee and shareholder of Galapagos NV. KVB is an employee and shareholder of Galapagos NV. RC has been paid as a speaker for AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Fresenius Kabi, Galapagos, Gilead, Lilly, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi and UCB, and worked as a paid consultant for Galapagos, Gilead, Janssen, Lilly and MSD. RA has received advisory fees from AbbVie, Amgen, Biogen, BMS, Celltrion, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer and Roche., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The phase 2 MANTA and MANTA-RAy studies were developed in consultation with global regulatory authorities to investigate potential impacts of filgotinib, a Janus kinase 1 preferential inhibitor, on semen parameters in men with active inflammatory diseases. Here we describe the methods and rationale for these studies., Methods and Rationale: The MANTA and MANTA-RAy studies included men (aged 21-65 years) with active inflammatory bowel disease (IBD) and rheumatic diseases, respectively. Participants had no history of reproductive health issues, and the following semen parameter values (≥ 5th percentile of World Health Organization reference values) at baseline: semen volume ≥ 1.5 mL, total sperm/ejaculate ≥ 39 million, sperm concentration ≥ 15 million/mL, sperm total motility ≥ 40% and normal sperm morphology ≥ 30%. Each trial included a 13-week, randomized, double-blind, placebo-controlled period (filgotinib 200 mg vs placebo, up to N = 125 per arm), for pooled analysis of the week-13 primary endpoint (proportion of participants with ≥ 50% decrease from baseline in sperm concentration). All semen assessments were based on two samples (≤ 14 days apart) to minimize effects of physiological variation; stringent standardization processes were applied across assessment sites. From week 13, MANTA and MANTA-RAy study designs deviated owing to disease-specific considerations. All subjects with a ≥ 50% decrease in sperm parameters continued the study in the monitoring phase until reversibility, or up to a maximum of 52 weeks, with standard of care as treatment. Overall conclusions from MANTA and MANTA-RAy will be based on the totality of the data, including secondary/exploratory measures (e.g. sperm motility/morphology, sex hormones, reversibility of any effects on semen parameters)., Conclusions: Despite the complexities, the MANTA and MANTA-RAy studies form a robust trial programme that is the first large-scale, placebo-controlled evaluation of potential impacts of an advanced IBD and rheumatic disease therapy on semen parameters., Trial Registration: EudraCT numbers 2017-000402-38 and 2018-003933-14; ClinicalTrials.gov identifiers NCT03201445 and NCT03926195., (© 2022. The Author(s).)

Background: On Wednesday 18/03/2020 Belgium was placed in lockdown in order to curb the spread of COVID-19. Lockdown can lead to loneliness, boredom, anger, anxiety and depression, which in turn have an influence on food choices and physical activity (PA). This study aims to map the adjustments in food choices and PA by Flemish adults during lockdown., Methods: Chi square tests were performed to investigate the relationship between adjustments in food choices, PA and demographic variables., Results: A total of 1.129 respondents filled in the online questionnaire, aged between 18 and 81 years. The healthiest food choices were made by respondents living alone during lockdown, whilst people cohabiting with others increased their PA significantly. Moreover, the dietary adjustments of adults living with children evolved more favourably to healthier choices then those cohousing with other adults. However, respondents living with other adults showed a more favourable pattern regarding adjustments in PA. The strongest increase in sedentary behaviour was observed in students., Conclusions: This study shows the impact of lockdown on both PA and food choices, where healthier adjustments were observed in PA and respondents were prone to consume unhealthier food.