Non-radiographic Spondyloarthritis Research Articles

Probability of the 10-year Risk of Hip and Major Osteoporotic Fracture in Non-radiographic Axial Spondyloarthritis.

Fracture risk in non-radiographic spondyloarthritis is underestimated. A reliable tool such as the Fracture Risk Assessment tool (FRAX) may assess this risk probability. This study aimed to assess the fracture risk by the FRAX score in patients with nr-axSpA and to determine factors associated with high fracture risk. We conducted a retrospective study of nr-axSpA patients meeting the Assessment of SpondyloArthritis International Society (ASAS) classification criteria for spondyloarthritis. All patients had Bone Mineral Density (BMD) by dual-energy X-ray absorptiometry (DEXA). The 10- year probability of major osteoporotic fracture (MOF) and hip fracture (HF) was calculated using the Fracture Risk Assessment Tool (FRAX). Among 40 patients with nr-axSpA, 27 were women (67.5%). Their mean age was 43.7 ± 12.1 years. The mean disease duration was 3.15 ± 2.7 years. Eighteen patients (45%) had osteopenia, and 12 patients (30%) had osteoporosis. The median HF FRAX was 0% [0-1.2]. The median MOF FRAX was 0.5% [0.3-1.8]. MOF FRAX was positively correlated with age (p = 0.002), disease onset age (p = 0.006), disease duration (p = 0.024), and the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) (p < 0.0001), and negatively correlated with daily calcium intake (p < 0.0001). HF FRAX was positively correlated with mSASSS (p < 0.0001) and negatively correlated with daily calcium intake (p = 0.005). Our study confirmed the frequency of bone loss during nr-axSpA and showed that osteoporotic risk fracture was related not only to traditional risk factors for osteoporosis but also to disease-related factors.

Comparative Efficacy of Biologic Disease-Modifying Anti-Rheumatic Drugs for Non-Radiographic Axial Spondyloarthritis: A Systematic Literature Review and Bucher Indirect Comparisons.

Biologic disease-modifying anti-rheumatic drugs (bDMARDs), including certolizumab pegol (CZP), are effective treatment options for the management of non-radiographic spondyloarthritis (nr-axSpA). In the absence of head-to-head comparisons in nr-axSpA, we conducted a systematic literature review (SLR) and indirect treatment comparison (ITC) to better understand the comparative efficacy of CZP vs. other bDMARDs. Literature searches were conducted in October 2020 in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials to identify randomized controlled trials in patients with nr-axSpA who had failed at least one non-steroidal anti-inflammatory drug and were treated with bDMARDs. Outcomes of interest included the Assessment of Spondyloarthritis international Society (ASAS), Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Functional Index (BASFI) and Disease Activity Index (BASDAI), and spinal pain score. Comparative efficacy was examined using a series of Bucher ITCs in subgroups matched by prior exposure to bDMARDs, disease duration, baseline C-reactive protein (CRP) levels/magnetic resonance imaging (MRI) status, and timepoints, to ensure comparability between studies. At 12-16weeks, treatment with CZP was significantly more likely to achieve ASAS20/40 response and ASDAS-inactive disease status vs. etanercept (ETN), ixekizumab (IXE), and secukinumab (SEC). CZP showed statistically significant improvement in BASDAI, BASFI, and total spine pain score over adalimumab (ADA), ETN, and IXE, and in BASFI over SEC. Among patients with objective signs of inflammation (OSI; elevated CRP levels and/or inflammation on MRI at baseline), CZP had a statistically significant advantage over ETN and SEC (with or without loading dose) in achieving ASAS40, whereas the comparisons with other bDMARDs did not show any statistically significant differences. In the overall matched population, CZP performed significantly better than most comparators in improving the clinical outcomes. Among patients with OSI, CZP was found to be superior to SEC (in the MRI-/CRP + and MRI + /CRP- subgroups) and ETN (in the MRI + /CRP- subgroup) and it was comparable to golimumab and IXE across the different OSI subgroups.

Five Cases of Non-radiographic Spondyloarthritis (nr-SpA) of Patients from a Tertiary Care Center in the Philippines: A Case Series

Five Cases of Non-radiographic Spondyloarthritis (nr-SpA) of Patients from a Tertiary Care Center in the Philippines: A Case Series

Disease activity and functional outcomes in non-radiographic spondyloarthritis versus ankylosing spondylitis – preliminary results

Introduction. Spondyloarthritis (SpA) represent a heterogeneous group of chronic inflammatory conditions sharing clinical, genetic, imaging and therapeutic features. Objectives. To analyze the clinical and biological characteristics, disease activity and functional impact in non-radiographic axial SpA (nr-axSpA) versus ankylosing spondylitis (AS). Material and method. Cross-sectional observational 12 months study on 46 patients with axial SpA; disease related parameters (clinical, biological, activity and functionality indices) and treatment options were compared in disease categories (nr-axSpA and AS). Outcomes. AS was diagnosed in 73.9%, and nr-axSpA in 26.1% cases. The majority of patients with nr-axSpA were women (72% vs 28%), with a younger age at onset (35.2±9.5 years vs 41±0.6 years) and a shorter time to diagnosis (3±0.5 vs 5.5±3.2 years). C-reactive protein levels were significantly higher in AS compared to nr-axSpA (2.2±0.5 vs 1.28±0.7)(p&lt;0.05). However, there were no significant differences between activity (ASDAS-CRP: 3.4±1.2 vs 3.2±0.9; BASDAI: 5.8±1.3 vs 5.6±1.1) and functionality measures (BASFI: 5.8±1.4 vs 5.7±1.2) in (p &gt;0.05) in AS vs nr-axSpA. Conclusions. Although nr-axSpA occurs frequently in women and may present with lower CRP levels, there are similar trends in disease activity and functional outcomes in both disease categories of the ax-SpA spectrum. Both nr-axSpA and AS patients experience high disease burden.

AB0772 SAFETY AND SURVIVAL ANALYSIS OF SECUKINUMAB TREATMENT IN A COHORT OF RHEUMATIC PATIENTS NAÏVE TO BIOLOGICAL THERAPY

BackgroundSecukinumab is a fully human monoclonal antibody that selectively binds to IL-17A and inhibits the interaction with the IL-17 receptor. IL-17A plays a key role in the pathogenesis of plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (SpA).ObjectivesTo describe the safety and survival profile of treatment with Secukinumab in a cohort of patients (pac) with PsA, AS and non-radiographic SpA naïve to biological therapy.MethodsDescriptive observational study. Patients: Cohort of patients with PsA, AS and non-radiographic SpA from the Rheumatology Service of the H.U.V. del Rocío of Seville who undergo treatment with Secukinumab 150mg sc/m as the first line of biological treatment. Main variable: Secukinumab suspension due to adverse event (AE) (mild: requires suspension, serious: hospital admission or death), inefficacy (primary or secondary failure), decision of the pac, clinical remission or other reasons.Secondary variables: age, sex, type of disease (PsA, AS or non-radiographic SpA), clinical manifestations (axial, peripheral affectation and both) other clinical manifestations (cutaneous affectation, enthesis and/or dactylitis). Time from diagnosis to start of biological therapy (months) and exposure time to Secukinumab (months). Concomitant treatment with DMARDs. Statistical analysis: The statistical package SPSS v21 was used. Qualitative variables were analyzed using the Chi2 and Fisher tests, as required. It was considered statistically significant, p values ​​&lt;0.05. Survival analysis was performed using Kaplan-Meier survival curves, compared using the Log-Rank test.Results171 patients who underwent treatment with Secukinumab during their disease were analyzed. A total of 61 patients naïve to biological therapy were included. The baseline characteristics of the sample are shown in Table 1. The patients received treatment with Secukinumab for a median of 35m (SD +/- 17.5m). The drug was suspended in 27 patients; In 19 patients (70%) due to inefficiency (11 due to primary failure and 8 due to secondary failure); in 5 patients due to mild AD (1 patient with mucocutaneous candidiasis); 3 patients due to loss of follow-up and 1 patient for their own decision. There were no serious AEs. The average exposure time of the drug was 32.7 months. Drug survival was 85%, 76%, 68%, and 56%, at 6 months, 1, 2, and 3 years, respectively, with an overall survival of 69%.Table 1.Basal featuresGender, men36 (59%)Age, years (average, SD)47,8 (+/- 13,3)Disease:-Psoriatic arthritis36 (59%)-Ankylosing spondylitis22 (36%)-Non-radiographic axial spondyloarthritis3 (5%)Disease time of evolution, years (average, SD)12,6 (+/- 8)Time from diagnosis to start of biological therapy with Secukinumab, years (median)6Clinical manifestations (%):-Axial involvement32 (52%)-Peripherical involvement43 (70%)-Axial and peripherical involvement.31 (50,8%)Other manifestations:-Enthesis18 (29%)-Dactylitis17 (27%)Concomitant treatment with DMARDs after 6 months of treatment with Secukinumab (n, %):-Methotrexate19 (31%)-Leflunomide7 (11,5%)-Sulfasalazine6 (9,8%)There was no association between the different diagnoses and drug suspension, both variables were independent (p=0.702) with a 5% significance level. There was also no evidence of a significative relationship between the type of involvement (axial/peripheral/both), and the suspension of treatment (p=0.743).ConclusionThe suspension of the drug due to AEs was small in our sample (8,2%) and the AEs detected were mild (including a mucocutaneous candidiasis). No serious AEs were observed. We found an overall drug survival of 70% in our study. These data are consistent with those published in the different clinical trials of the drug (FUTURE I, II and V, MEASURE I, II and III, PREVENT...). Therefore, we can conclude that Secukinumab constitutes a drug with a good security profile.Disclosure of InterestsNone declared

Secukinumab Associated Choroidal Neovascularization

A previously healthy 38-year-old woman with non-radiographic spondyloarthritis (nrSpA) developed juxta-foveal Choroidal Neovascularization (CNV) in the right eye three months after starting treatment with the anti-IL-17A inhibitor secukinumab. As there was no sign of ocular inflammation, no known association with CNV and this rheumatic disease, and other etiologic etiologies were excluded, this biologic agent was the suspected cause. Drug discontinuation and treatment with bevacizumab resulted in full suppression of the neovascular activity. IL-17 has a purported etiologic role in ocular neovascular diseases. The onset of this process in a patient receiving anti-IL-17 therapy suggests a possible causative role requiring further clarification.

Axial spondyloarthritis may protect against poor outcomes in COVID-19: propensity score matched analysis of 9766 patients from a nationwide multi-centric research network.

IntroductionThe outcomes of COVID-19 in patients with axial spondyloarthritis (ax-SpA) have not been explored in detail. Tumour necrosis factor inhibitors (TNFi) are commonly used for ax-SpA patients, and how they influence outcomes may have implications on COVID-19 management.MethodsA nationwide multi-centric research network was queried for patients with ax-SpA, including ankylosing spondylitis (AS) and non-radiographic SpA (nr-SpA) who had developed COVID-19. An equal number of propensity score(PS) matched controls were extracted from the database amongst patients with COVID-19 who did not have any inflammatory arthritis. Outcomes included mortality and others including hospitalization, intensive care unit, ventilation, acute kidney injury (AKI), renal replacement therapy, acute respiratory distress syndrome, cerebral infarction, venous thromboembolism (VTE), and sepsis.ResultsWe identified 9766 patients with ax-SpA (924 AS and 8842 nr-SpA) and 691,862 without SpA who had COVID-19. In the unmatched comparison, patients with ax-SpA had higher risk ratios (RR) for all outcomes. After matching for demographics and comorbidities, patients with ax-SpA had lower RR for mortality [RR: 0.707 (95% CI: 0.598–0.836), p < 0.0001], severe COVID-19 [RR: 0.791 (0.69–0.906), p = 0.0007], hospitalization [RR: 0.872 (0.826–0.921), p < 0.0001], and AKI [RR: 0.902 (0.816–0.997), p = 0.044]. Only the risk of VTE was higher in ax-SpA patients [RR: 1.219 (1.037–1.433), p = 0.016]. Amongst the ax-SpA group, males had worse outcomes in 9 out of the 11 domains except for VTE and cerebral infarction, while blacks had worse outcomes in all except for mortality and the need for renal replacement therapy. AS had similar risk ratios for all outcomes compared with nr-SpA except hospitalization [RR: 1.457 (1.03–2.06), p = 0.0318]. There was no difference in outcomes in patients who had received TNFi in the year previous to COVID-19 infection. Ax-SpA patients who had been prescribed non-steroidal anti-inflammatory drugs in the 3 months prior to COVID-19 had poorer outcomes.ConclusionIn conclusion, COVID-19 outcomes were better in patients with ax-SpA as compared with PS matched controls except for increased risk for VTE. The use of TNFi is not associated with better or worse outcomes. These apparently protective effects observed need to be validated and explored further. Key Points• Patients with axial spondyloarthritis have lower mortality and morbidity during COVID-19 infections as compared with propensity score matched controls.• Axial spondyloarthritis is associated with higher risks for venous thromboembolism during COVID-19.• There is no difference in outcomes between ankylosing spondylitis and non-radiographic spondyloarthritis except in rates of hospitalization, which were higher in ankylosing spondylitis.• Use of tumour necrosis factor inhibitors did not influence COVID-19 outcomes.

Анкилозирующий спондилит: подходы к диагностике и клиническая эффективность упадацитиниба

Ankylosing spondilitis (AS) is a relatively common disease mainly affecting young males and presenting with chronic inflammation of the spine and the sacroiliac joints. AS is one of the forms of axial spondyloarthritis (SpA). Diagnosis of AS is usually delayed on average by 8-10 years from the first symptoms. SpA should be considered both in males and females who present with chronic low back pain starting before the age of 45 years and at least one additional factor (inflammatory back pain, HLA-B27, sacroileitis, peripheral arthritis, enthesitis, dactylitis, psoriasis, uveitis, inflammatory bowel disease, family history for SpA, elevated ESR and/or C-reactive protein, and good response to NSAIDs). Such patients should be referred to rheumatologist. MRI improves early diagnosis of AS since it detects inflammatory changes, which precede structural damage of the sacroiliac joints (nonradiographic SpA). Physical exercises and NSAIDs are the first-line treatment for AS, whereas TNF and interleukin-17 inhibitors are widely used as a second-line therapy. Upadacitinib is the first JAK-inhibitor that was approved for the treatment of active AS in adult patients who have responded inadequately to conventional therapy. The authors discuss clinical cases demonstrating efficacy of upadacinitib in patients with AS.

A cross-sectional study on clinical characteristics of Saudi axial spondylarthritis: preliminary results.

To describe Spondyloarthritis (SpA) patients in a single center (preliminary phase), Build connections to establish local cohorts, Saudi Registry, and publication in Gulf and Arab database. This prospective observational cohort consists of patients with spondylarthritis (SpA) diagnosed by a rheumatologist. Patients with AS were defined as those who met the modified New York criteria for Ankylosing Spondylitis (AS) 1984. All other patients with axial SpA who did not meet the radiology criteria of modified New York criteria for Ankylosing Spondylitis were classified as having non-radiographic axial SpA based on Assessment of SpondyloArthritis International Society (ASAS) diagnostic criteria for axial spondyloarthropathy. The study group comprised 106 patients with SpA (49 patients with AS and 57 patients with non-radiographic axial SpA). Patients with non-radiographic axial SpA and patients with AS who had previously been treated with biologic disease-modifying drugs (DMARDs) were 66.67 percent and 83.67 percent, respectively. In patients with AS, CRP and age significantly impact disease activities (p<0.05). The overall mean ASDAS score was 2.3 ± 0.7. This study has shown a more detailed description of the largest Saudi cohort reported yet. Interestingly, both disease groups, Ankylosing spondylitis and non-radiographic spondyloarthritis showed a lower prevalence of HLA-B27 is lower in the general Saudi population compared to other nations including Caucasians, thus, limiting its use as a diagnostic tool. The majority of both groups, nearly three-quarters of all patients (74.53%) in biologic DMARD treatment, and only (22.64%) used csDMARD treatment, which may help control disease activity and showing easier access and availability of these therapies to the patient. Patients with non-radiographic axial SpA showed slightly higher Extra-articular Manifestations comparing with AS patients.

Клинический случай болезни Шейермана-Мау как ренессанс вековой истории

Modern strategy for management of spondyloarthritis (SpA) is aimed at the earliest possible diagnosis and treatment of diseases. Emergence of nonradiographic SpA in clinical practice necessitates differential diagnosis of this condition from a wide range of diseases including juvenile spondylodysplasia. The article presents a clinical case of newly-diagnosed Scheuermann-Mau disease in an adult patient

The IgG galactosylation ratio is higher in spondyloarthritis patients and associated with the MRI score.

MRI is an important tool for evaluating inflammation levels and assessing treatment response in patients with ankylosing spondylitis (AS). However, it is expensive and requires experienced physicians. The goal of this study was to identify a biomarker correlated with the MRI score. A total of 558 spondyloarthritis (SpA) patients including 527 AS patients, 10 psoriasis (PsA) patients, and 21 non-radiographic SpA (nr-SpA) patients and 725 controls were enrolled for the studies. Plasma IgG galactosylation (IgG-Gal) level was measured by mass spectrometry. Clinical indexes such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and C-reactive protein (CRP) were measured in all AS patients. MRIs and X-rays were obtained from 65 AS patients who were followed up for 6months. The IgG-Gal ratio was twice as high in the AS patients compared with the controls. It correlated with inflammation indices which is evaluated by MRI according to SPARCC. (Pearson coefficient/p value was 0.6/7E10-6). In addition, AS patients with a higher IgG-Gal ratio at baseline tended to show greater improvement in inflammation scores by MRI both in 3-month follow-up and 6-month follow-up. The IgG-Gal ratio was significantly increased in AS patients. In clinical care, it may be used as a potential biomarker for diagnosis in the future. Key Points • IgG galactosylation level was abnormal in SpA patients. • IgG galactosylation level was associated with MRI indices.

Diagnosis of spondyloarthritis: Application of criteria in clinical practice

Spondyloarthritis (SpA) is an umbrella term for a group of inflammatory musculoskeletal conditions characterized by predominant involvement of the spine, the lower limb joints, and the entheses. The Assessment of SpA International Society (ASAS) group classifies SpA into axial SpA (axSpA) and peripheral SpA. axSpA was further divided into radiographic SpA and nonradiographic SpA. Classification criteria are meant for research purposes to enroll a homogeneous cohort, unlike diagnostic criteria, which are meant for diagnosing diseases in the community and therefore must include all the heterogeneous manifestations of a disease. Inflammatory low back pain is one of the most important features in history to be elicited in the diagnosis of axSpAs. It should not be used in isolation and always combined with other features of SpA. Magnetic resonance imaging (MRI) is the gold standard and is the only imaging modality capable of detecting both inflammatory and structural changes. A positive MRI finding should be interpreted in the relevant clinical context, and an alternative differential diagnosis for sacroiliitis should be considered if the clinical picture is atypical of SpA. The presence of HLA B 27 in isolation is neither diagnostic of SpAs nor its absence rules out the diagnosis. Erythrocyte sedimentation rate and C-reactive protein are the commonly used biomarkers in SpA but do not always correlate with disease activity. The ASAS criteria have been tested for its validity, though there were concerns regarding its specificity. In this narrative review various criteria available for classifying SpAs have been discussed and their strengths, weaknesses, and usefulness in the diagnosis of SpA in our everyday practice have been appraised . Various referral strategies and usefulness of these criteria and parameters in the Indian context have also been discussed.

High prevalence of spondyloarthritis in sarcoidosis patients with chronic back pain

IntroductionChronic back pain (CBP) is a frequent complaint in patients with sarcoidosis, which challenges the clinician as multiples causes may potentially underlie this symptom. Interestingly, some reports suggest that the coexistence of sarcoidosis and spondyloarthritis (SpA) may be frequent. This study aimed to determine the prevalence of axial radiographic and non-radiographic SpA in patients with sarcoidosis and CBP and assess the association between patient characteristics and SpA. MethodsThis cross-sectional study enrolled 64 patients with a diagnosis of sarcoidosis and CBP. Patients describing CBP underwent a full spine MRI and radiography. All patients with inflammatory CBP underwent complementary sacroiliac joint MRI. The diagnosis of axial SpA was based on the Assessment of SpondyloArthritis International Society classification criteria. ResultsAmong the 64 patients (49 women) with sarcoidosis and CBP, 29 had inflammatory pain; 15/64 had a diagnosis of SpA (23.4% [95% CI: 13.7–35.6], 14/29 (48.3% [95% CI: 29.5–67.5] of those with inflammatory back pain). MRI sacroiliitis was found in 13 patients. On both univariate and multivariate analysis, SpA diagnosis was associated with inflammatory CBP (OR=28.5, 95% CI: 1.91–425.4) and sarcoidosis limited to the thorax (OR=6.74, 95% CI: 1.08–42.1). SpA was associated with young age (p = 0.0093) and male sex (p = 0.021) only on univariate analysis. Besides, 12/64 patients (18.8%, 95% CI: 10.1–30.5) had a diagnosis of sarcoidosis spine bone lesions, 7/64 (10.9%, 95% CI: 4.5–21.2) symptomatic vertebral fracture and 30/64 (46.9%, 95% CI: 34.3–59.8) degenerative spine. ConclusionsThe prevalence of SpA is increased in sarcoidosis patients with inflammatory back pain. The systematic use of spine and sacroiliac MRI in this subgroup is justified. The association between other patient features and SpA needs further confirmation.

Frequency of concomitant fibromyalgia in rheumatic diseases: Monocentric study of 691 patients.

Fibromyalgia (FM) is a confounding factor for diagnosing and assessing rheumatic disease activity. This study sought to assess the extent of this syndrome in rheumatism patients at a French rheumatology department. This monocentric epidemiological study enrolled all patients consulting due to rheumatoid arthritis (RA), spondyloarthritis (SpA), or connective tissue disease (CTD). FM diagnosis was confirmed or excluded according to the rheumatologist opinion and the 1990 American College of Rheumatology (ACR) criteria. We enrolled 691 patients, including 451 women (65.3%), with a mean age of 55.8 years (18-93). Of the enrolled patients, 325 presented with RA, 298 SpA [59 psoriatic arthritis (PsA), 137 ankylosing spondylitis (AS), 64 non-radiographic SpA (nr-SpA), and 38 peripheral SpA], and 71 CTD. The rheumatologist established FM diagnosis in 97 patients (14%), while 55 (8%) fulfilled the 1990 ACR criteria. The frequency of FM was lower in RA patients (4.9% by 1990 ACR criteria; 7.7% by expert opinion) compared to SpA (11.1% by 1990 ACR, p < 0.05; 17.5% by expert opinion, p < 0.003) and CTD (11.3% by 1990 ACR, non-significant; 28.2% by expert opinion, p < 0.001). In the SpA subgroups, FM was more common in the nr-SpA than in PsA or AS (23.9%, 9.6%, and 6.4%, by 1990 ACR, p = 0.001; 37.3%, 13.5%, and 7.2%, by expert opinion, p < 0.001). FM-like symptoms are commonly associated with rheumatic diseases. The frequency of FM is particularly high in non-radiographic axial SpA, thus raising questions about the specificity of the Assessment of SpondyloArthritis International Society (ASAS) classification criteria.

COMPARISON OF NON-RADIOGRAPHIC SPONDYLOARTHRITIS VERSUS ANKYLOSING SPONDYLITIS PATIENTS UNDERGOING BIOLOGICAL THERAPY – DATA FROM A ROMANIAN COHORT

Both non-radiographic spondyloarthritis (nr-SpA) and ankylosing spondylitis (AS) are medical conditions that belong to the axial spondyloarthritis spectrum; these two terms reveal the extent of sacroiliitis assessed by conventional x-ray or MRI. According to the latest classification criteria (ASAS, 2009), clinicians are able to differentiate patients with nr-SpA from AS and to follow their disease progression. The present study aims to compare the two patient categories undergoing biological therapy with an anti-TNF agent and indicate distinct disease features. We included 94 patients in treatment with IFX, ADL, ETA or GOL and monitored clinical, biological and disease activity parameters. The nr-SpA subgroup included a higher percentage of female patients; AS patients presented higher values of the CRP at follow-up visits; there were no significant differences between the two groups regarding the HLA-B27 presence, uveitis history or smoking status. Patients with an inactive disease status had a lower BMI, shorter disease duration and an early initiation of biological therapy, so that we suggest a close and regular monitoring of these two entities.

Golimumab for the treatment of axial spondyloarthritis

ABSTRACTIntroduction: Anti-TNF drugs have represented an epochal revolution in the treatment of rheumatoid arthritis and spondyloarthritis. In the field of axial spondyloarthritis, golimumab, a fully human monoclonal anti-TNFα administered subcutaneously every 4 weeks, has shown significant efficacy and good safety in patients with ankylosing spondylitis. More recently, it was also indicated as an effective treatment for patients suffering from non-radiographic axial spondyloarthitits.Areas covered: A systematic literature search was completed, using the largest electronic databases (Medline, Embase and Cochrane), with the aim to review all data concerning the administration of golimumab in patients suffering from axial spondyloartritis.Expert opinion: In the 16-week GO-AHEAD study, golimumab was effective in patients with non-radiographic spondyloarthritis with high levels of CRP and/or positive MRI findings, but not in subjects with both negative CRP and MRI. This finding allows for the addressing the of anti-TNF treatment more specifically. Preliminary data concerning an open-label extension of the GO-AHEAD study outlined the high retention-rate of the drug at 52 weeks. The production of antibodies against golimumab is rare and it seems to exert scarce influence on the drug performances. In conclusion, golimumab appears as a very useful and well tolerated anti-TNF agent.

The Evolving Biosimilar Landscape: Approval of the First Etanercept Biosimilar in Europe, An Interview With Emilio Martín-Mola

On January 14th 2016, SB4 (Benepali®) received marketing authorisation application approval from the European Commission (EC). It is the first biosimilar to etanercept available in Europe as well as the first subcutaneous anti-tumour necrosis factor biosimilar. Benepali® was approved for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic spondyloarthritis), and plaque psoriasis. SB4 adds to the available biologic armamentarium of biosimilars in rheumatology, which also includes two infliximab biosimilars; one under the brand names Remsima® and Inflectra®, and the other under the brand name Flixabi®. Unlike infliximab biosimilar, which is a chimeric monoclonal antibody, SB4 is a fusion protein. We aimed to review the current European Medicines Agency (EMA) requirements for the approval of biosimilars and how these products can integrate into daily clinical practice in rheumatology. To that effect, we recently discussed with Dr Emilio Martín-Mola about the European framework for approval of biosimilars and the controversies that may surround this new category of medicinal products. We discussed how the advent of biosimilars in rheumatology has the potential to truly be a game-changer for both physicians and patients.

Editorial: The Vital Role of Randomized Controlled Trials in Arthritis &amp; Rheumatology

Editorial: The Vital Role of Randomized Controlled Trials in <i>Arthritis &amp; Rheumatology</i>

Similarities and differences between patients fulfilling axial and peripheral ASAS criteria for spondyloarthritis: Results from the Esperanza Cohort

To describe and compare the characteristics of patients fulfilling the ASAS criteria for axial Spondyloarthritis (SpA) versus peripheral SpA . Baseline dataset from the ESPeranza cohort was used. In this programme, patients were referred to rheumatologist in case of (1) age <45 years, (2) symptoms duration 3-24 months and (3) inflammatory back pain (IBP) or asymmetrical arthritis or spinal/joint pain plus ≥1 SpA features. The programme was developed between April 2008 and June 2011. Data from 377 patients fulfilling the ASAS classification criteria for SpA were used. Descriptive analysis was employed to compare demographic and disease characteristics between patients with axial SpA versus peripheral SpA. Two hundred and ninety (77.2%) patients were classified as axial SpA (109 ankylosing spondylitis and 182 non-radiographic SpA) while 86 (22.8%) patients had peripheral SpA. Age, gender distribution and degree of disease activity were similar in both groups. Patients with axial SpA were referred after having symptoms for a longer period and had more frequently uveitis and positive HLA-B27. Patients with peripheral SpA had in a greater percentage more working disability and had more frequently enthesitis, psoriasis, dactylitis and inflammatory bowel disease (IBD). The ASAS classification criteria for SpA seem to classify patients within the same spectrum of disease beyond the predominant symptoms at onset. However, despite having similar degree of disease activity, time to be referred to rheumatologist is increased in axial SpA patients compared with peripheral SpA patients.

Facteurs pronostiques dans les spondyloarthrites axiales

In the field of spondyloarthritis, knowledge of prognostic factors predicting severity and radiographic progression to ankylosis is an important issue. This review will address the predictors of disease severity, the various factors associated with structural progression and its long-term functional impairment, and finally those associated with progression to ankylosing spondylitis for non-radiographic spondyloarthritis.