Background
Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction. Retention of golimumab was high in clinical trial extensions and real-world studies up ...to 5 years in patients with immune-mediated rheumatic diseases.
Objective
To assess the probability of real-world long-term retention of treatment with golimumab up to 7 years after treatment initiation.
Methods
This retrospective noninterventional study involved analysis of the Spanish biological drugs registry, BIOBADASER. Adults who had ever received golimumab for rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA), and had initiated it > 6 months before the analysis date, were included.
Results
Among 685 patients (28.5% RA, 42.9% SpA, 28.6% PsA), the overall probability of retention of golimumab treatment since initiation was 71.7% (95% confidence interval 68.1–74.9) at year 1, 60.5% (56.5–64.2%) at year 2, 55.6% (51.5–59.5%) at year 3, 50.6% (46.2–54.8%) at year 4, 45.1% (40.1–50.0%) at year 5, 44.2% (39.0–49.3) at year 6, and 39.5% (32.8–46.2) at year 7. Retention was greater in patients with axial SpA or PsA versus RA (
p
< 0.001) and when golimumab was used as first-line treatment versus third or later lines (
p
< 0.001). Factors associated with greater golimumab retention in Cox regression included use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy. Steroids were associated with lower retention.
Conclusion
In this real-world study of RA, axial SpA, and PsA patients, the retention rate of golimumab was 39.5% at year 7.
Key Points
• Retention of biological treatment provides a marker of drug effectiveness and patient satisfaction.
• This real-world study of 685 patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA), or psoriatic arthritis (PsA) showed that golimumab treatment had a retention rate up to 39.5% at year 7.
• Greater golimumab retention was associated with use as first-line biological therapy, having axial SpA or PsA rather than RA, and concomitant methotrexate therapy
This study aimed at determining socio-demographic and clinical factors of primary Sjögren syndrome (pSS) associated with osteoporosis (OP) and fragility fracture. SJOGRENSER is a cross-sectional ...study of patients with pSS, classified according to American European consensus criteria developed in 33 Spanish rheumatology departments. Epidemiological, clinical, serological and treatment data were collected and a descriptive analysis was conducted. Bivariate and multivariate analyses were performed using a binomial logistic regression to study the factors associated with OP and fragility fracture in pSS. 437 patients were included (95% women, with a median age of 58.6 years). 300 women were menopausal (76.4%). Prevalence of OP was 18.5% in men (
N
= 21) this measured 19%. A total of 37 fragility fractures were recorded. In the multivariate analysis, there was an association between OP and age: in the 51–64 age range (menopausal women), the OR measured 9.993 (95% CI 2301–43,399,
p
= 0.002); In the age > 64 years group, OR was 20.610 (4.679–90.774,
p
< 0.001); between OP and disease duration, OR was 1.046 (1.008–1085,
p
= 0.017); past treatment with corticosteroids, OR 2.548 (1.271–5.105,
p
= 0.008). Similarly, an association was found between fragility fractures and age: in the 51–64 age group, OR measured 5.068 (1.117–22,995,
p
= 0.035), age > 64 years, OR was 7.674 (1.675–35,151,
p
< 0.009); disease duration, OR 1.049 (CI 1.003–1097,
p
< 0.036) and the ESSDAI index, OR 1.080 (1.029–1134,
p
= 0.002). Patients with pSS can develop osteoporosis and fragility fractures over the course of the disease. Age, corticosteroids treatment and disease duration were associated with the development of OP. Disease duration and ESSDAI were associated with the development of fractures in patients with pSS.
The better understanding of the safety of biologic DMARDs (bDMARDs), as well as the emergence of new bDMARDs against different therapeutic targets and biosimilars have likely influenced the use ...patterns of these compounds over time. The aim of this study is to assess changes in demographic characteristics, disease activity and treatment patterns in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) who started a first- or second-line biologic between 2007 and mid-2020. Patients diagnosed with RA, PsA or AS included in the BIOBADASER registry from January 2007 to July 2020 were included. According to the start date of a first- or second-line biologic therapy, patients were stratified into four time periods: 2007-2009; 2010-2013; 2014-2017; 2018-2020 and analyzed cross-sectionally in each period. Demographic and clinical variables, as well as the type of biologic used, were assessed. Generalized linear models were applied to study the evolution of the variables of interest over time periods, the diagnosis, and the interactions between them. A total of 4543 patients initiated a first biologic during the entire time frame of the study. Over the four time periods, disease evolution at the time of biologic initiation (p < 0.001), disease activity (p < 0.001), retention rate (p < 0.001) and the use of tumor necrosis factor inhibitors as a first-line treatment (p < 0.001) showed a significant tendency to decrease. Conversely, comorbidities, as assessed by the Charlson index (p < 0.001), and the percentage of patients using bDMARDs in monotherapy (p < 0.001), and corticosteroids (p < 0.001) tended to increase over time. Over the entire period of the study's analysis, 3289 patients started a second biologic. The following trends were observed: decreased DAS28 at switching (p < 0.001), lower retention rates (p = 0.004), and incremental changes to the therapeutic target between the first and second biologic (p < 0.001). From 2007 until now rheumatic patients who started a biologic were older, exhibited less clinical activity, presented more comorbidities, and switched to a different biologic more frequently and earlier.
The aim of this study was to analyze the longitudinal practice patterns of prophylaxis of glucocorticoid-induced osteoporosis in patients with polymyalgia rheumatica (PMR). Patients diagnosed with ...PMR were collected retrospectively in two rheumatology departments. In addition to demographic and diagnostic criteria, the chart review included the following information at baseline and at follow-up: doses of prednisone, prescription of calcium, vitamin D and bisphosphonates, bone mass measurement (BMD) and fragility fractures. We analyzed the percentage of patients undergoing BMD and were prescribed a bisphosphonate over the years. We evaluated 158 patients: 117 of them were women, mean age was 73 years, and they had an average follow-up of 4.8 years. 104 patients (66 %) received osteoporosis medication during the first visit, 44 of them were given bisphosphonate. During follow-up, another 30 treatments with bisphosphonate were added (46 % overall) while 37 cases (23 %) received no treatment with calcium or bisphosphonate. BMD was performed in 111 patients (69 %; 53 % of males and 76 % of females). Factors associated with the use of bisphosphonates were female sex (OR 4.4, 95 % CI 4.02–4.86), BMD (OR 2.4, 95 % CI 2.05–2.78) and commencement of treatment after the year 2005 (54 vs 37 %, OR 1.93, 95 % CI 1.60–2.26). No significant differences were found with age, initial doses of prednisone or the hospital. According to recent prevention guidelines, treatment with biphosphonate should have been administered in more than 90 % of patients. Although prophylaxis of glucocorticoid-induced osteoporosis in patients with PMR has increased in the recent years, many patients do not receive prophylaxis with bisphosphonate during the first visit.
Aim
To assess the golimumab retention rate during up to 8 years of follow up, and any associated factors.
Methods
Retrospective analysis of the BIOBADASER (Spanish registry of biological drugs) ...database, assessing all adults who had ever started golimumab >6 months before the analysis for an approved indication (rheumatoid arthritis RA, axial spondyloarthritis SpA or psoriatic arthritis PsA).
Results
Among 885 patients (RA 267, axial SpA 370, PsA 248) receiving 944 cycles of golimumab, the retention rate of golimumab was 71.1% (95% confidence interval: 68.0–73.9) at year 1% and 37.7% (95% CI: 33.3–42.1) at year 7 and at year 8. Retention was higher when golimumab was used as the first biological drug (81.7% at year 1, 49.9% at year 7, p < 0.001). In Cox regression analysis, factors associated with golimumab retention included use as first‐line therapy (hazard ratio HR for discontinuation 1.52 for second‐ and 1.79 for third/later‐line vs. first‐line), use in axial SpA or PsA rather than RA (HR for axial SpA vs. RA 0.59, for PsA vs. Rheumatoid arthritis 0.67), and treatment with concomitant methotrexate (HR 0.67). Factors associated with golimumab discontinuation were corticosteroid use (HR 1.46) and disease activity above median (HR 1.29) at golimumab initiation.
Conclusion
Based on this retrospective analysis of the BIOBADASER registry, nearly two‐fifths (37.7%) of adult rheumatology patients initiating golimumab will remain on treatment for 8 years, with a higher probability of retention in axial SpA or PsA indications and when golimumab is used as first biologic.
Spondyloarthritis (SpA) is one of the most common extraintestinal manifestations of inflammatory bowel disease (IBD). Diagnostic delay must be avoided.
We assessed the validity of SpA screening ...criteria (any of the following characteristics: chronic low back pain with onset before 45 years of age; inflammatory lower back pain or alternating buttock pain; arthritis; heel enthesitis; dacylitis; HLA-B27 positivity; sacroiliitis on imaging).
This was a multicenter cross-sectional observational study in IBD patients aged ≥18 years. After evaluating the SpA screening criteria, the gastroenterologists referred the participants to the rheumatologists, who determined whether the patient fulfilled the screening criteria and carried out the necessary tests for SpA diagnosis.
35 (11.7%) out of 300 patients were diagnosed with SpA. The combination with the best balance between sensitivity and specificity (91.4% and 72.1%, respectively, when applied by the rheumatologists; 80% and 78.9%, when applied by the gastroenterologists) for SpA screening, was fulfillment of any of the following: chronic low back pain with onset before age 45 years, inflammatory low back pain or alternating buttock pain, arthritis, or dactylitis.
This is one of the first studies to validate SpA screening criteria in IBD patients in routine clinical practice.
To assess the efficacy of abatacept (ABA) in RA patients with interstitial lung disease (ILD) (RA-ILD).
This was an observational, multicentre study of RA-ILD patients treated with at least one dose ...of ABA. ILD was diagnosed by high-resolution CT (HRCT). We analysed the following variables at baseline (ABA initiation), 12 months and at the end of the follow-up: Modified Medical Research Council (MMRC) scale (1-point change), forced vital capacity (FVC) or diffusion lung capacity for carbon monoxide (DLCO) (improvement or worsening ≥10%), HRCT, DAS on 28 joints evaluated using the ESR (DAS28ESR) and CS-sparing effect.
We studied 263 RA-ILD patients 150 women/113 men; mean (s.d.) age 64.6 (10) years. At baseline, they had a median duration of ILD of 1 (interquartile range 0.25-3.44) years, moderate or severe degree of dyspnoea (MMRC grade 2, 3 or 4) (40.3%), FVC (% of the predicted) mean (s.d.) 85.9 (21.8)%, DLCO (% of the predicted) 65.7 (18.3) and DAS28ESR 4.5 (1.5). The ILD patterns were: usual interstitial pneumonia (UIP) (40.3%), non-specific interstitial pneumonia (NSIP) (31.9%) and others (27.8%). ABA was prescribed at standard dose, i.v. (25.5%) or s.c. (74.5%). After a median follow-up of 12 (6-36) months the following variables did not show worsening: dyspnoea (MMRC) (91.9%); FVC (87.7%); DLCO (90.6%); and chest HRCT (76.6%). A significant improvement of DAS28ESR from 4.5 (1.5) to 3.1 (1.3) at the end of follow-up (P < 0.001) and a CS-sparing effect from a median 7.5 (5-10) to 5 (2.5-7.5) mg/day at the end of follow-up (P < 0.001) was also observed. ABA was withdrawn in 62 (23.6%) patients due to adverse events (n = 30), articular inefficacy (n = 27), ILD worsening (n = 3) and other causes (n = 2).
ABA may be an effective and safe treatment for patients with RA-ILD.
Update on the Use of Steroids in Rheumatoid Arthritis García-Magallón, Blanca; Silva-Fernández, Lucía; Andreu-Sánchez, José Luis
Reumatologia clinica,
September-October 2013, 2013 Sep-Oct, 2013-09-00, Letnik:
9, Številka:
5
Journal Article
Recenzirano
Corticosteroids are a mainstay in the therapy of rheumatoid arthritis (RA). In recent years, a number of high-quality controlled clinical trials have shown their effect as a disease-modifying ...anti-rheumatic drug (DMARD) and a favorable safety profile in recent-onset RA. Despite this, they are more frequently used as bridge therapy while other DMARDs initiate their action than as true disease-modifying agents. Low-dose corticosteroid use during the first two years of disease slows radiologic damage and reduces the need of biologic therapy aimed at reaching a state of clinical remission in recent-onset RA. Thus, their systematic use in this clinical scenario should be considered.
Los glucocorticoides son un componente fundamental en el tratamiento de la artritis reumatoide (AR). En los últimos años, numerosos ensayos clínicos controlados de alta calidad metodológica han demostrado su acción como fármaco antirreumático modificador de enfermedad (FAME) y un favorable perfil de seguridad en la AR de reciente comienzo. No obstante, es frecuente que se utilicen más como terapia puente hasta que otros FAME comienzan a actuar que como auténticos agentes modificadores de enfermedad. Los glucocorticoides a dosis bajas durante los 2 primeros años de la enfermedad frenan el deterioro radiológico y reducen la necesidad de usar agentes biológicos para conseguir la remisión clínica en la AR de inicio por lo que se debería valorar su utilización sistemática en este contexto clínico.
Fungal arthritis is usually of haematogenous origin, and mainly affects patients with impaired cellular immunity or users of intravenous drugs. The infection in immunocompetent patients is generally ...caused by direct inoculation of the microorganism through an invasive device. The experience of azole therapy in these patients is limited.
We report a case of arthritis caused by Scedosporium apiospermum characterized by its slow onset, lack of response to posaconazole and caspofungin, and its successful resolution after surgical debridement and treatment with voriconazole.
Treatment with voriconazole and surgical debridement is an effective therapy for arthritis due to S. apiospermum.
The retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug’s overall effectiveness. The golimumab retention rate as first-line ...biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4–89.5%), 73.7% (67.1–79.1%), 68.5% (60.5–75.1%), 60.6% (50.2–69.5%) and 57.1% (44.9–67.5%), respectively. Retention was similar across indications (
p
= 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (
p
< 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.
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