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.
Reducing the dose of biological therapy (BT) when patients with immune-mediated arthritis achieve a sustained therapeutic goal may help to decrease costs for national health services and reduce the ...risk of serious infection. However, there is little information about whether such a decision can be applied universally. Therefore, the objective of this study was to develop appropriateness criteria for reducing the dose of BT in patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), and peripheral spondyloarthritis (pSpA).
The RAND/UCLA appropriateness method was coordinated by experts in the methodology. Five rheumatologists with clinical research experience in RA and/or SpA selected and precisely defined the variables considered relevant when deciding to reduce the dose of BT in the 3 diseases, in order to define patient profiles. Ten rheumatologists with experience in prescribing BT anonymously rated each profile on a scale of 1 (completely inappropriate) to 9 (completely appropriate) after revising a summary of the evidence obtained from 4 systematic literature reviews carried out specifically for this project.
A total of 2,304 different profiles were obtained for RA, 768 for axSpA, and 3,072 for pSpA. Only 327 (14.2%) patient profiles in RA, 80 (10.4%) in axSpA, and 154 (5%) in pSpA were considered appropriate for reducing the dose of BT. By contrast, 749 (32.5%) patient profiles in RA, 270 (35.3%) in axSpA, and 1,243 (40.5%) in pSpA were considered inappropriate. The remaining profiles were considered uncertain.
Appropriateness criteria for reducing the dose of BT were developed in 3 inflammatory conditions. These criteria can help clinicians treating these disorders to optimize the BT dose. However, further research is needed, since more than 50% of the profiles were considered uncertain and the real prevalence of each profile in daily clinical practice remains unknown.
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
To evaluate the association between low disease activity according to the new ASDAS nomenclature and the physician therapeutic decisions in patients with axial spondyloarthritis (axSpA).
Longitudinal ...retrospective study including patients diagnosed with axSpA receiving a tumor necrosis factor-inhibitor between January 2014 and June 2019 as a first treatment. For each visit, disease activity was determined afterwards according to the new ASDAS nomenclature (inactive, low, high and very high activity), and the physician's therapeutic decision was recorded. The association between disease activity and the physician's decision was evaluated through descriptive statistics.
A total of 304 visits of 104 patients with axSpA were analyzed. For those visits where a low activity ASDAS score was obtained, the physician's therapeutic decision was no escalation of treatment in 98.2% of cases. However, for those visits with a high or very high disease activity ASDAS score, the physician's therapeutic decision was to escalate treatment in 33.7% and 82.8% of cases respectively.
The state measured by the ASDAS index formerly defined as ‘moderated disease activity’ is considered in clinical practice as ‘low disease activity’ because of the physician's choice in these situations to not-escalate the treatment. Our data substantiate the recent updating in ASDAS nomenclature.
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.
Digestive involvement (DI) has been reported in 10-30% of primary Sjögren's syndrome (pSS) patients, and few studies have systematically analysed the prevalence of DI in pSS patients. The aim of this ...study was to describe DI prevalence in pSS patients from the Sjögrenser Study, and to analyse its clinical associations.
All patients included in the Sjögrenser study, a Spanish multicentre randomised cohort, containing demographic, clinical and histologic data, have been analysed retrospectively. Patients were classified according to the presence of DI (oesophageal, gastric, intestinal, hepatic and pancreatic), and we have performed DI clinical associations, descriptive statistics, Student t or χ2 test, and uni and multivariate logistic regression.
From 437 included patients, 95% were women, with a median age of 58 years, 71 (16.2%) presented DI: 21 (29.5%) chronic atrophic gastritis, 12 (16.9%) oesophageal motility dysfunction, 3 (4.2%) lymphocytic colitis, 18 (25.3%) primary biliary cholangitis, 15 (21.1%) autoimmune hepatitis, 7 (9.8%) pancreatic involvement and 5 (7%) coeliac disease. Half of them developed DI at the same time or after pSS diagnosis. Patients with DI were significantly older at pSS diagnosis (p=0.032), more frequently women (p=0.009), presented more autoimmune hypothyroidism and C3 hypocomplementaemia (p=0.040), and were treated more frequently with glucocorticoids, immunosuppressant and biologic therapies. Patients with pancreatic involvement presented more central nervous system and renal involvement, Raynaud's phenomenon, lymphoma and C3/C4 hypocomplementaemia.
DI is frequent in Sjögrenser patients, mainly in the form of autoimmune disorders, and seem to be associated with a more severe phenotype. Our results suggest that DI should be evaluated in pSS patients, especially those with more severe disease.
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.
To assess fibromyalgia (FM) prevalence in a large cohort of primary Sjögren's syndrome patients (pSS) from a National Database.
Data included in the national retrospective register of pSS patients of ...the Spanish Society of Rheumatology (SJOGRENSER) were analysed.
437 pSS patients were included and a 14.6% of FM prevalence was found. FM-pSS patients significantly showed more constitutional, fatigue and arthralgia symptoms, splenomegaly, genital, skin and ear involvement and dyslipidaemia (p<0.05), as well as higher ESSPRI and SSDAI scores (p<0.01). Several symptomatic treatments were more frequently used in FM-pSS patients. No differences were observed in laboratory markers, imaging techniques or histologic inflammatory findings. Patients with FM showed statistically more fatigue than pSS without FM. In the multivariate logistic regression analysis several features were associated to pSS-FM patients.
We show data on a reliable prevalence of FM in pSS patients and its multiple associated factors along with the presence of higher disease activity scores than patients who did not show FM. The presence of fatigue, arthralgia, constitutional symptoms and dyslipidaemia were more likely to coexist in pSS-FM patients.
PDF
