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1.
Medicina (B Aires) ; 84(4): 760-763, 2024.
Article in English | MEDLINE | ID: mdl-39172578

ABSTRACT

In this report, we present the case of a woman with clinical characteristics of hypercalcemia due to ectopic production of 1,25(OH)2D. She reported a history of aesthetic surgery with gluteal fillers. The formation of granulomas after these interventions were previously described. In this case, surgical removal of the foreign formations was attempted with clinical stability during 3 years.


Presentamos el caso de una mujer con características clínicas de hipercalcemia secundaria a la producción ectópica de 1,25(OH)2D. La paciente informó una historia de rellenos glúteos con fines estéticos. La formación de granulomas posterior a este tipo de intervenciones fue previamente descrita por otros autores. En este caso se intentó la extirpación quirúrgica de las formaciones extrañas con estabilidad clínica durante 3 años.


Subject(s)
Granuloma, Foreign-Body , Hypercalcemia , Humans , Hypercalcemia/etiology , Female , Granuloma, Foreign-Body/surgery , Granuloma, Foreign-Body/etiology , Granuloma/surgery , Granuloma/etiology , Dermal Fillers/adverse effects , Middle Aged , Cosmetic Techniques/adverse effects , Buttocks , Treatment Outcome
2.
Climacteric ; : 1-8, 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-39037037

ABSTRACT

Fibromyalgia (FM) and climacteric conditions share common epidemiological and clinical features, with FM symptoms often beginning during menopause. Musculoskeletal pain, arthralgia, myalgia and other symptoms are frequently seen in both conditions. Some research suggests a link between the cessation of sex hormones and FM symptoms. Women with FM tend to experience more severe symptoms after menopause, and the severity of FM symptoms can worsen in women who have had a hysterectomy with or without oophorectomy. Despite these similarities, it is essential to treat FM and climacteric conditions separately and follow established guidelines for management. However, it is also important to recognize that both conditions can coexist in the same patient. It is crucial to note that there is limited evidence supporting the effectiveness of menopausal hormone therapy for primary FM management. Therefore, menopausal hormone therapy should not be recommended for FM unless the patient also has climacteric syndrome.

6.
Reumatol. clín. (Barc.) ; 20(1): 32-42, Ene. 2024. ilus, tab
Article in Spanish | IBECS | ID: ibc-228932

ABSTRACT

Objetivos: Explorar la experiencia de las personas con fibromialgia (FM) en países latinoamericanos con objeto de identificar problemas en la atención sanitaria y otros ámbitos potencialmente solucionables. Métodos: Estudio cualitativo con enfoque fenomenológico y de análisis de contenido a través de grupos focales y metodología de viaje del paciente (Ux del inglés User Experience). Se llevaron a cabo 9 grupos focales virtuales con pacientes con FM y profesionales sanitarios en Argentina, México y Colombia reclutados a partir de informantes clave y redes sociales. Resultados: Participaron 43 personas (33 clínicos y 10 pacientes). Los agentes que interaccionan con el paciente en la enfermedad se encuentran en 3 esferas: la de la atención sanitaria, la del apoyo y vida laboral y la del contexto socioeconómico. La línea del viaje presenta 2 grandes tramos, 2 bucles y una línea discontinua delgada. Los 2 grandes tramos representan los tiempos que van desde los primeros síntomas hasta la visita médica y desde el diagnóstico hasta el seguimiento. Los bucles incluyen: 1.°) sucesión de diagnósticos, tratamientos erróneos y derivaciones a especialistas y 2.°) nuevos síntomas cada cierto tiempo, visitas a especialistas y dudas diagnósticas. Pocos pacientes logran la fase final de autonomía. Conclusión: El viaje de una persona con FM en Latinoamérica está lleno de obstáculos. La meta deseada es que todos los agentes entiendan que el automanejo por parte del paciente con FM es una parte indispensable del éxito, y solo se puede lograr accediendo a recursos de forma precoz y guiado por profesionales.(AU)


Objectives: To explore the patient journey of people with fibromyalgia (FM) in Latin American countries in order to identify problems in health care and other areas that may be resolvable. Methods: Qualitative study with phenomenological and content analysis approach through focus groups and patient journey (Ux; User Experience) methodology. Nine virtual focus groups were conducted with FM patients and healthcare professionals in Argentina, Mexico and Colombia recruited from key informants and social networks. Results: Forty-three people participated (33 were clinicians and 10 were patients). The agents interacting with the patient in their disease journey are found in three spheres: healthcare (multiple medical specialists and other professionals), support and work life (including patient associations) and socioeconomic context. The line of the journey presents two large sections, two loops and a thin dashed line. The two major sections represent the time from first symptoms to medical visit (characterized by self-medication and denial) and the time from diagnosis to follow-up (characterized by high expectations and multiple contacts to make life changes that are not realized). The two loop phases include (1) succession of misdiagnoses and mistreatments and referrals to specialists and (2) new symptoms every so often, visits to specialists, diagnostic doubts, and impatience. Very few patients manage to reach the final phase of autonomy. Conclusion: The journey of a person with FM in Latin America is full of obstacles and loops. The desired goal is for all the agents involved to understand that self-management by the patient with FM is an essential part of success, and this can only be achieved with early access to resources and guidance from professionals.(AU)


Subject(s)
Humans , Male , Female , Fibromyalgia/drug therapy , Chronic Pain/drug therapy , Patient Navigation , Health Status Disparities , Health Personnel , Qualitative Research , Rheumatology , Rheumatic Diseases , Argentina , Mexico , Colombia , Focus Groups
7.
Reumatol Clin (Engl Ed) ; 20(1): 32-42, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38182526

ABSTRACT

OBJECTIVES: To explore the patient journey of people with fibromyalgia (FM) in Latin American countries in order to identify problems in health care and other areas that may be resolvable. METHODS: Qualitative study with phenomenological and content analysis approach through focus groups and patient journey (Ux; User Experience) methodology. Nine virtual focus groups were conducted with FM patients and healthcare professionals in Argentina, Mexico and Colombia recruited from key informants and social networks. RESULTS: Forty-three people participated (33 were clinicians and 10 were patients). The agents interacting with the patient in their disease journey are found in three spheres: healthcare (multiple medical specialists and other professionals), support and work life (including patient associations) and socioeconomic context. The line of the journey presents two large sections, two loops and a thin dashed line. The two major sections represent the time from first symptoms to medical visit (characterized by self-medication and denial) and the time from diagnosis to follow-up (characterized by high expectations and multiple contacts to make life changes that are not realized). The two loop phases include (1) succession of misdiagnoses and mistreatments and referrals to specialists and (2) new symptoms every so often, visits to specialists, diagnostic doubts, and impatience. Very few patients manage to reach the final phase of autonomy. CONCLUSION: The journey of a person with FM in Latin America is full of obstacles and loops. The desired goal is for all the agents involved to understand that self- management by the patient with FM is an essential part of success, and this can only be achieved with early access to resources and guidance from professionals.


Subject(s)
Fibromyalgia , Humans , Fibromyalgia/diagnosis , Fibromyalgia/therapy , Fibromyalgia/complications , Latin America , Mexico , Qualitative Research , Focus Groups
8.
Osteoporos Int ; 35(3): 451-468, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37955683

ABSTRACT

The RICO study indicated that most patients would like to receive information regarding their fracture risk but that only a small majority have actually received it. Patients globally preferred a visual presentation of fracture risk and were interested in an online tool showing the risk. PURPOSE: The aim of the Risk Communication in Osteoporosis (RICO) study was to assess patients' preferences regarding fracture risk communication. METHODS: To assess patients' preferences for fracture risk communication, structured interviews with women with osteoporosis or who were at risk for fracture were conducted in 11 sites around the world, namely in Argentina, Belgium, Canada at Hamilton and with participants from the Osteoporosis Canada Canadian Osteoporosis Patient Network (COPN), Japan, Mexico, Spain, the Netherlands, the UK, and the USA in California and Washington state. The interviews used to collect data were designed on the basis of a systematic review and a qualitative pilot study involving 26 participants at risk of fracture. RESULTS: A total of 332 women (mean age 67.5 ± 8.0 years, 48% with a history of fracture) were included in the study. Although the participants considered it important to receive information about their fracture risk (mean importance of 6.2 ± 1.4 on a 7-point Likert scale), only 56% (i.e. 185/332) had already received such information. Globally, participants preferred a visual presentation with a traffic-light type of coloured graph of their FRAX® fracture risk probability, compared to a verbal or written presentation. Almost all participants considered it important to discuss their fracture risk and the consequences of fractures with their healthcare professionals in addition to receiving information in a printed format or access to an online website showing their fracture risk. CONCLUSIONS: There is a significant communication gap between healthcare professionals and patients when discussing osteoporosis fracture risk. The RICO study provides insight into preferred approaches to rectify this communication gap.


Subject(s)
Osteoporosis , Osteoporotic Fractures , Humans , Female , Middle Aged , Aged , Patient Preference , Pilot Projects , Risk Assessment , Canada/epidemiology , Osteoporosis/complications , Osteoporotic Fractures/epidemiology , Osteoporotic Fractures/etiology , Communication , Risk Factors
10.
Arch Osteoporos ; 18(1): 81, 2023 06 15.
Article in English | MEDLINE | ID: mdl-37316765

ABSTRACT

Osteoporosis management has become more relevant as the life expectancy increases. In Ecuador, approximately 19% of adults over 65 years of age have been diagnosed with osteoporosis. There is no national consensus for the management and prevention of the disease being this proposal the first Ecuadorian consensus. INTRODUCTION: In Ecuador, it is estimated that around 19% of adults over 65 years of age have osteoporosis. Due to the increase in life expectancy in the world population, the evaluation and management of osteoporosis has become more relevant. Currently, there is no national consensus for the management and prevention of the disease. The Ecuadorian Society of Rheumatology presented the project for the elaboration of the first Ecuadorian consensus for the management and prevention of osteoporosis. METHODS: A panel of experts in multiple areas and extensive experience was invited to participate. The consensus was carried out using the Delphi method. Six working dimensions were created: definition and epidemiology of osteoporosis, fracture risk prediction tools, non-pharmacological treatment, pharmacological treatment, calcium and vitamin D, and glucocorticoid-induced osteoporosis. RESULTS: The first round was held in December 2021, followed by the second round in February 2022 and the third round in March 2022. The data was shared with the specialists at the end of each round. After three rounds of work, a consensus was reached for the management and prevention of osteoporosis. CONCLUSION: This is the first Ecuadorian consensus for the management and treatment of postmenopausal osteoporosis.


Subject(s)
Osteoporosis, Postmenopausal , Osteoporosis , Adult , Female , Humans , Ecuador/epidemiology , Consensus , Osteoporosis/diagnosis , Osteoporosis/epidemiology , Osteoporosis/therapy , Calcium, Dietary
11.
Aging Clin Exp Res ; 35(7): 1405-1416, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37222927

ABSTRACT

Normal bone remodeling depends of a balance between bone forming cells, osteoblasts and bone resorbing cells, the osteoclasts. In chronic arthritides and some inflammatory and autoimmune diseases such as rheumatoid arthritis, there is a great constellation of cytokines produced by pannus that impair bone formation and stimulate bone resorption by inducing osteoclast differentiation and inhibiting osteoblast maturation. Patients with chronic inflammation have multiple causes that lead to low bone mineral density, osteoporosis and a high risk of fracture including circulating cytokines, impaired mobility, chronic administration of glucocorticoids, low vitamin D levels and post-menopausal status in women, among others. Biologic agents and other therapeutic measures to reach prompt remission might ameliorate these deleterious effects. In many cases, bone acting agents need to be added to conventional treatment to reduce the risk of fractures and to preserve articular integrity and independency for daily living activities. A limited number of studies related to fractures in chronic arthritides were published, and future investigation is needed to determine the risk of fractures and the protective effects of different treatments to reduce this risk.


Subject(s)
Arthritis, Rheumatoid , Bone Resorption , Fractures, Bone , Humans , Female , Osteoclasts , Bone and Bones , Osteoblasts , Cytokines
12.
Reumatol Clin (Engl Ed) ; 19(4): 215-222, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37005129

ABSTRACT

The first experiences with a group of drugs called immune checkpoint inhibitors for the treatment of cancer were described in 2010. They are currently used in many tumours, with successful survival outcomes but a new profile of adverse events. This new spectrum of immune-mediated toxicities includes an exaggerated inflammatory response of T lymphocyte and the development of autoimmune diseases or similar pathologies. Of these, of particular note are the rheumatological toxicities. This review aims to alert internists and rheumatologists to their recognition and clinical management.


Subject(s)
Autoimmune Diseases , Neoplasms , Rheumatic Diseases , Rheumatology , Humans , Immune Checkpoint Inhibitors/therapeutic use , Immunotherapy/adverse effects , Autoimmune Diseases/chemically induced , Autoimmune Diseases/drug therapy , Autoimmune Diseases/complications , Neoplasms/drug therapy , Rheumatic Diseases/complications
13.
Reumatol. clín. (Barc.) ; 19(4): 215-222, Abr. 2023. mapas, tab
Article in Spanish | IBECS | ID: ibc-218869

ABSTRACT

En 2010 se conocieron las primeras experiencias con un grupo de medicamentos denominados inhibidores de los puntos de control inmunitario (IPCI) para el tratamiento del cáncer. Actualmente se utilizan en diferentes tumores y estadios, mejorando la sobrevida de los pacientes pero generando un nuevo perfil de toxicidad. Este nuevo espectro de toxicidades inmunomediadas (irAE) es generado por una exagerada respuesta inflamatoria de linfocitosT que puede desarrollar enfermedades autoinmunes o patologías similares. Entre ellas se hallan las toxicidades reumatológicas. Esta revisión se propone alertar a los internistas y reumatólogos a reconocer las irAE reumatológicas y conocer su manejo clínico.(AU)


The first experiences with a group of drugs called immune checkpoint inhibitors for the treatment of cancer were described in 2010. They are currently used in many tumours, with successful survival outcomes but a new profile of adverse events. This new spectrum of immune-mediated toxicities includes an exaggerated inflammatory response of Tlymphocyte and the development of autoimmune diseases or similar pathologies. Of these, of particular note are the rheumatological toxicities. This review aims to alert internists and rheumatologists to their recognition and clinical management.(AU)


Subject(s)
Humans , Drug-Related Side Effects and Adverse Reactions , Musculoskeletal System , Arthritis , Antibodies, Monoclonal , Myositis , Immunotherapy , Rheumatology , Rheumatic Diseases
14.
Mod Rheumatol ; 33(4): 657-667, 2023 Jul 04.
Article in English | MEDLINE | ID: mdl-35921235

ABSTRACT

OBJECTIVES: To evaluate the long-term safety and efficacy of filgotinib (FIL) for Japanese patients with rheumatoid arthritis (RA) and limited/no prior methotrexate (MTX) exposure. We present a Japanese population subanalysis of a global randomised-controlled trial at Week 52 and interim long-term extension (LTE) to Week 48 through June 2020. METHODS: Patients were randomised to FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, or MTX for 52 weeks. At completion, eligible patients could enrol in the LTE. Those receiving FIL continued; those receiving MTX were rerandomised (blinded) to FIL 200 or 100 mg upon discontinuation of MTX. After a 4-week washout period, MTX could be re-added. RESULTS: Adverse event rates at Week 52 and in the LTE to Week 48 were comparable across treatment groups. Week 52 American College of Rheumatology 20% improvement (ACR20) rates were 83% (19/23), 82% (9/11), 75% (9/12), and 76% (19/25) for FIL 200 mg plus MTX, FIL 100 mg plus MTX, FIL 200 mg, and MTX, respectively. Through LTE Week 48, ACR20 rates were maintained. CONCLUSIONS: In the 56 Japanese patients treated with FIL, efficacy was maintained through Week 52 and beyond, with no increases in the incidence of adverse events.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Animals , Humans , Antirheumatic Agents/adverse effects , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Double-Blind Method , Drug Therapy, Combination , East Asian People , Methotrexate/adverse effects , Treatment Outcome
15.
Aging Clin Exp Res ; 34(11): 2591-2602, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36348222

ABSTRACT

Guidelines and recommendations developed and endorsed by the International Osteoporosis Foundation (IOF) are intended to provide guidance for particular pattern of practice for physicians who usually prescribe glucocorticoid (GC) therapy, and not to dictate the care of a particular patient. Adherence to the recommendations within this guideline is voluntary and the ultimate determination regarding their application should be made by the physician in light of each patient's circumstances. Guidelines and recommendations are intended to promote a desirable outcome but cannot guarantee any specific outcome. This guideline and its recommendations are not intended to dictate payment, reimbursement or insurance decisions. Guidelines and recommendations are subjected to periodic revisions as a consequence of the evolution of medicine, technology and clinical practice. A panel of Latin American (LATAM) experts specialized in osteoporosis with recognized clinical experience in managing patients with glucocorticoid-induced osteoporosis (GIO) met to produce evidence-based LATAM recommendations for the diagnosis and management of GIO. These guidelines are particularly intended to general practitioners and primary care physicians who prescribe GC treatments in LATAM to guide their daily clinical practice in terms of evaluation, prevention and treatment of GIO. These recommendations were based on systematic literature review using MEDLINE, EMBASE, SCOPUS and COCHRANE Library database during the period from 2012 to 2021. Randomized clinical trials (RCT), systematic reviews of RCT, controlled observational studies, guidelines and consensus were considered. Based on the review and expert opinion the panel members voted recommendations during two successive rounds of voting by panel members. Agreements for each statement were considered if a concordance of at least 70% was achieved following Delphi methodology. Grading of recommendations was made according to the Oxford Centre for the Evidence-based Medicine (EBM) criteria. Among five GIO guidelines and consensus initially identified, two of them (American College of Rheumatology 2017 and the Brazilian Guidelines 2021) were selected for comparison considering the latter as the most current guides in the LATAM region. Based on this methodology fifty statements were issued. All of them but four (1.20, 1.21, 1.23 and 4.2) attained agreement.


Subject(s)
General Practitioners , Osteoporosis , Humans , Glucocorticoids/adverse effects , Latin America , Osteoporosis/chemically induced , Osteoporosis/diagnosis , Osteoporosis/drug therapy , Hispanic or Latino
16.
J Bone Miner Res ; 37(6): 1136-1146, 2022 06.
Article in English | MEDLINE | ID: mdl-35340062

ABSTRACT

In a randomized clinical trial in patients initiating glucocorticoid therapy (GC-I) or on long-term therapy (GC-C), denosumab every 6 months increased spine and hip bone mineral density at 12 and 24 months significantly more than daily risedronate. The aim of this study was to evaluate the effects of denosumab compared with risedronate on bone strength and microarchitecture measured by high-resolution peripheral quantitative computed tomography (HR-pQCT) in GC-I and GC-C. A subset of 110 patients had high-resolution peripheral quantitative computed tomography (HR-pQCT) scans of the distal radius and tibia at baseline and at 12 and 24 months. Cortical and trabecular microarchitecture were assessed with standard analyses and failure load (FL) with micro-finite element analysis. At the radius at 24 months, FL remained unchanged with denosumab and significantly decreased with risedronate in GC-I (-4.1%, 95% confidence interval [CI] -6.4, -1.8) and, in GC-C, it significantly increased with denosumab (4.3%, 95% CI 2.1, 6.4) and remained unchanged with risedronate. Consequently, FL was significantly higher with denosumab than with risedronate in GC-I (5.6%, 95% CI 2.4, 8.7, p < 0.001) and in GC-C (4.1%, 95% CI 1.1, 7.2, p = 0.011). We also found significant differences between denosumab and risedronate in percentage changes in cortical and trabecular microarchitectural parameters in GC-I and GC-C. Similar results were found at the tibia. To conclude, this HR-pQCT study shows that denosumab is superior to risedronate in terms of preventing FL loss at the distal radius and tibia in GC-I and in increasing FL at the radius in GC-C, based on significant differences in changes in the cortical and trabecular bone compartments between treatment groups in GC-I and GC-C. These results suggest that denosumab could be a useful therapeutic option in patients initiating GC therapy or on long-term GC therapy and may contribute to treatment decisions in this patient population. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).


Subject(s)
Denosumab , Glucocorticoids , Bone Density , Bone and Bones , Denosumab/pharmacology , Denosumab/therapeutic use , Glucocorticoids/adverse effects , Humans , Radius , Risedronic Acid/pharmacology , Tibia/diagnostic imaging
18.
Mod Rheumatol ; 32(2): 273-283, 2022 Feb 28.
Article in English | MEDLINE | ID: mdl-34910203

ABSTRACT

OBJECTIVES: To evaluate the efficacy and safety of filgotinib for Japanese patients with rheumatoid arthritis (RA) and limited or no prior methotrexate (MTX) exposure. METHODS: Data up to 24 weeks were analysed for 71 Japanese patients from a 52-week global Phase 3 study. Patients with RA and limited or no prior MTX exposure were randomised in a 2:1:1:2 ratio to filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, or MTX. Maximum MTX dose was 15 mg/week. Primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at Week 24. RESULTS: Week 24 ACR20 rates in Japanese patients were 82.6%, 90.9%, 83.3%, and 80.0% for filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg, and MTX, respectively. Greater ACR20 rates with filgotinib vs MTX occurred at Week 2. Greater proportions receiving filgotinib vs MTX achieved DAS28-CRP <2.6 at Weeks 12 and 24. Adverse event rates were comparable across treatments and between the Japanese and overall populations. CONCLUSIONS: While Week 24 ACR20 rates were similar, filgotinib provided faster responses and higher remission rates vs MTX. In Japanese patients with RA and limited or no prior MTX exposure, filgotinib was generally well tolerated.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Finches , Animals , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Double-Blind Method , Drug Therapy, Combination , Humans , Japan , Methotrexate/adverse effects , Pyridines , Treatment Outcome , Triazoles
19.
Nutrients ; 13(11)2021 Oct 27.
Article in English | MEDLINE | ID: mdl-34836090

ABSTRACT

Vascular Calcification (VC), low bone mass and fragility fractures are frequently observed in ageing subjects. Although this clinical observation could be the mere coincidence of frequent age-dependent disorders, clinical and experimental data suggest that VC and bone loss could share pathophysiological mechanisms. Indeed, VC is an active process of calcium and phosphate precipitation that involves the transition of the vascular smooth muscle cells (VSMCs) into osteoblast-like cells. Among the molecules involved in this process, parathyroid hormone (PTH) plays a key role acting through several mechanisms which includes the regulation of the RANK/RANKL/OPG system and the Wnt/ß-catenin pathway, the main pathways for bone resorption and bone formation, respectively. Furthermore, some microRNAs have been implicated as common regulators of bone metabolism, VC, left ventricle hypertrophy and myocardial fibrosis. Elucidating the common mechanisms between ageing; VC and bone loss could help to better understand the potential effects of osteoporosis drugs on the CV system.


Subject(s)
Aging/physiology , Osteoporosis/physiopathology , Vascular Calcification/physiopathology , Bone Resorption/physiopathology , Humans , Osteogenesis/physiology
20.
RMD Open ; 7(2)2021 08.
Article in English | MEDLINE | ID: mdl-34385364

ABSTRACT

OBJECTIVE: This analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs). METHODS: This was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population. RESULTS: Of 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed. CONCLUSION: FIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.


Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Drug Therapy, Combination , Humans , Methotrexate/adverse effects , Prognosis , Pyridines , Treatment Outcome , Triazoles
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