Treatment Of axSpA Research Articles

Real-World Retention and Clinical Effectiveness of Secukinumab for Axial Spondyloarthritis: Results From the Canadian Spondyloarthritis Research Network.

Axial spondyloarthritis (axSpA) is a chronic, immune-mediated, inflammatory condition consisting of 2 clinical subsets: nonradiographic axSpA and ankylosing spondylitis, the latter having an estimated prevalence of 0.2% to 1% in Canada. Secukinumab (SEC) received Health Canada approval in 2016 for the treatment of adults with axSpA who have responded inadequately to conventional treatment, and has demonstrated efficacy and safety through extensive clinical trials. However, there is limited evidence on its real-world use in Canada. The objective of this study was to use the Canadian Spondyloarthritis (CanSpA) Research Network to describe real-world retention and effectiveness of SEC in the Canadian axSpA population. This was an observational cohort study of Canadian patients with axSpA aged 18 to 65 years within the CanSpA network who had received treatment with SEC. Patients were indexed on the first date of SEC initiation. Retention and clinical effectiveness were assessed at 12 months postindex. Clinical effectiveness was measured as the proportion in remission and change in disease activity using multiple clinical indices. A total of 146 patients were included. Overall retention was estimated at 62.9%. Low disease activity (ie, Bath Ankylosing Spondylitis Disease Activity Index < 4) was achieved in 29.2% of patients, and 2% had achieved remission based on the Ankylosing Spondylitis Disease Activity Score. Bath Ankylosing Spondylitis Metrology Index scores improved by more than 60% from baseline to 12 months. The results of this real-world study of Canadian patients with axSpA, one of the first of its kind, support the effectiveness of SEC for treatment of axSpA. The CanSpA network presents an opportunity to continue building and improving the real-world evidence base for treatment of Canadian patients with spondyloarthritis.

Management of Axial Spondyloarthritis - Insights into Upadacitinib.

Although the pathogenesis of spondyloarthritis (SpA) has still not been elucidated our options to treat SpA have definitely improved in the last decades. There are two main types of SpA: (i) axial spondyloarthritis (axSpA), also covering the classical ankylosing spondylitis (AS) which is largely equivalent to radiographic (r)-axSpA but different from non-radiographic (nr)-axSpA, and (ii) peripheral SpA (pSpA) also covering psoriatic arthritis (PsA) as the main subtype. The subtype nr-axSpA has historically developed because the approval of drugs for AS did not cover forms without structural changes in the sacroiliac joints which is mandatory in the 1984 New York criteria. The definitions for axSpA are based on the 2009 Assessments in AxSpA International Society (ASAS) classification criteria. Several biologic disease modifying anti-rheumatic drugs (bDMARDs) such as the tumor necrosis factor alpha inhibitors (TNFi) and the interleukin-17-inhibitors (IL-17i) are approved mostly for the whole spectrum of SpA including axSpA and PsA but L-17i does not work in inflammatory bowel disease (IBD). Targeted synthetic (ts) DMARDs cover mainly the janus kinase (JAK)-inhibitors which have recently been developed to inhibit inflammation in several rheumatic and other immune mediated diseases such as IBD. Indeed, the physiologic mechanism of JAK-mediated signal transduction has been recognized as an important target because the inhibition of its actions was shown to successfully work as a therapeutic mechanism. There are now 4 small molecule JAK inhibitors (JAKi) that currently play a role in rheumatology with variable selectivity for the four different JAK isoforms: tofacitinib, baricitinib, upadacitinib and filgotinib. In this review, we summarize current clinical trial data and evaluate the use of the JAK1 selective inhibitor upadacitinib in the treatment of axSpA, including nr-axSpA and r-axSpA. Even though the efficacy and safety of upadacitinib over shorter periods of time has been convincing to date, long-term trials are needed to fully establish its performance and also evaluate the safety at higher doses, and its use in PsA.

Certolizumab Pegol Treatment in Patients with Axial-Spondyloarthritis-Associated Acute Anterior Uveitis: a Narrative Review.

BackgroundAcute anterior uveitis (AAU) affects up to 40% of patients with axial spondyloarthritis (axSpA). An effective treatment for patients with axSpA that reduces the risk of AAU flares while also targeting axial symptoms is therefore highly desirable. Tumor necrosis factor inhibitors (TNFis) have been shown effective for treatment of axSpA and AAU occurrence, with guidelines conditionally recommending treating patients with axSpA and associated AAU with TNFi monoclonal antibodies. To date, most available data on the impact of TNFis on AAU in axSpA are from observational, open-label studies without parallel comparator arms. However, there is a growing body of evidence describing the impact of the TNFi certolizumab pegol (CZP) on the incidence of axSpA-associated AAU.ObjectiveOur objective was to collate data pertaining to the impact of CZP in axSpA-associated AAU in patients across the full axSpA spectrum.MethodsData were obtained from four industry-supported phase 3 and 4 clinical trials (C-VIEW, C-axSpAnd, C-OPTIMISE, and RAPID-axSpA). To supplement these data, a targeted literature review was performed through searches of MEDLINE, Embase, and reference lists.ResultsAvailable data from 1467 patients from the C-VIEW, C-axSpAnd, C-OPTIMISE, and RAPID-axSpA trials show CZP to be effective in AAU in patients across the full axSpA spectrum, reducing AAU flares when compared with placebo or pretreatment period. No differences in AAU outcomes were reported when stratified by axSpA subgroup age or sex. The targeted literature review identified six further studies of CZP in spondyloarthritis-associated AAU, only one of which was specific to axSpA.ConclusionCZP was effective in reducing AAU incidence in clinical trials with patients with axSpA. The targeted literature review, however, highlighted that there remains a paucity of data beyond these trials. Data from comparative studies would further enhance the body of evidence on the effects of CZP in patients with axSpA who develop AAU.Graphical abstract Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-022-00486-1.

Prevalence and neglected rate of sacroiliitis on lumbar spine CT in patients with low back pain.

The study aims to investigate the prevalence and neglected rate of sacroiliitis on lumbar spine computed tomography (CT) in patients with low back pain. From January 2016 to December 2020, a total of 4827 patients (mean age: 35.4 ± 9.5years) who underwent lumbar spine CT examinations were included in this retrospective study. The CT degree of sacroiliitis in all study population were retrospectively reviewed by two radiologists. The independent sample t-test was used to compare the continuous values and chi-squared or Fisher's exact test was used to compare the categorized values. Sacroiliitis was identified in 514 of 4827 patients (10.6%). Patients with sacroiliitis were significantly younger than those without sacroiliitis (32.1 ± 8.9 vs. 35.8 ± 9.5years, p < 0.001). Moreover, significantly more patients with sacroiliitis had HLA-B27 (p < 0.001) positivity and inflammatory back pain syndrome (p = 0.003) than those without sacroiliitis. Among the 514 patients, sacroiliitis was recognized on primary reading in 386 patients (75.1%) but was neglected in the remaining 128 patients (24.9%). Of the 386 patients, 371 patients were followed up, and finally, 295 patients of them (79.5%) were diagnosed with axSpA. Radiologists should pay careful and more attention to sacroiliac joint on lumbar spine CT for early diagnosis of sacroiliitis in young patients with low back pain, which could result in early diagnosis and treatment of axSpA.

Chronic back pain in axial spondylarthritis : Current diagnostic challenges and treatment possibilities

Among chronic back diseases, axial spondylarthritis (axSpA) is the entity with the largest spectrum of specific anti-inflammatory treatment modalities; however, from ageneral medical perspective axSpA is only ranked as another etiology of back pain to be considered after spinal cord or cauda equina compression, bone metastases, epidural abscess or osteomyelitis of the vertebrae, radiculopathy or spinal stenosis. Due to its relatively low prevalence and mostly later occurring sequelae, there is a danger that axSpA will be arelatively neglected entity for specialists. This article recapitulates the recommendations of the Assessment of Ankylosing Spondyloarthritis International Society (ASAS). This review addresses the practical aspects of the detailed evaluation of treatment attempts carried out so far with nonsteroidal anti-inflammatory drugs (NSAID) for back pain. Undesired effects on the symptoms of the lower intestinal tract could be of particular interest here. The sex-specific differences in the response to treatment with tumor necrosis factor (TNF) inhibitors in axSpA are mentioned. Further aspects of treatment options with biologics in axSpA are discussed based on a case of maintained remission after acourse of interleukin (IL) 17 inhibitors in undifferentiated, HLA-B27 and magnetic resonance imaging (MRI) positive axSpA and long-standing good treatment response to IL-12/23 inhibitor treatment in axial psoriatic arthritis. Furthermore, the literature is discussed with respect to uveitis, carditis and amyloidosis in the context of axSpA. The early diagnosis in the general medical context and the specific consideration of numerous predictive factors play an increasingly more important role in the personalized treatment of axSpA.

A Real-World Study on the Effect of Imrecoxib for Patients with Axial Spondyloarthritis.

PurposeNon-steroidal anti-inflammatory drugs (NSAIDs) have generally been viewed as first-line therapy for axial spondyloarthritis (axSpA). Imrecoxib is a selective COX-2 inhibitor developed independently in China. At present, only one single-center RCT trial has shown that imrecoxib is equally effective as celecoxib in treating axSpA. Based on real-world data, our study aims to explore the efficiency of imrecoxib and TNF inhibitor (TNFi) combined with imrecoxib in treating axSpA.Patients and MethodsA total of 163 patients with axSpA who had more than two follow-up records in 6 months and treated with imrecoxib/celecoxib/TNFi combined with imrecoxib/TNFi combined with celecoxib from the First Affiliated Hospital of Anhui Medical University SpA Real World Database (AHSpA) were selected for analysis of our study. The linear mixed model was used to compare efficacy indexes before and after treatment and between different groups, adjust baseline measurement value and follow-up time. The Kaplan–Meier survival analysis was used to identify the differences in cumulative clinical remission rates between groups with different treatment at the follow-up period.ResultsResults showed that after treatment ASDAScrp was slightly improved in imrecoxib group and celecoxib group within 6 months (p < 0.05). CRP, ESR, BASDAI, ASDAScrp, BASFI, occiput to wall distance and finger floor distance all significantly improved in TNFi combined with imrecoxib group and TNFi combined with celecoxib group within 6 months (all p < 0.05). According to the Kaplan–Meier survival curve and Log rank test analysis, the clinical remission rate was not significantly different between different treatment during 24-month follow-up (all p > 0.05).ConclusionASDAScrp improved slightly within 6 months after treatment with imrecoxib, and TNFi combined with imrecoxib significantly improved multiple effect indexes in axSpA patients. The efficacy of imrecoxib and celecoxib in the treatment of axSpA is equivalent. Also, they have the same efficacy after being combined with TNFi.

P272 Pregnancy outcomes in women receiving biological therapy for axial spondyloarthritis

Abstract Background/Aims Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting the spine and sacroiliac joints. It is typically diagnosed before the age of thirty-five in patients presenting with pain and stiffness of the lower back. Treatment of axSpA is multidisciplinary and medical management initially consists of non-steroidal anti-inflammatory medications. For patients with high disease activity or poor symptomatic control, treatment may be escalated to biological therapies including, tumour necrosis factor (TNF) alpha inhibitors. Thus, treatment with these powerful medications is likely to coincide with the time that patients may wish to start a family. Currently, there is very limited evidence regarding the safety of biological therapies during pregnancy and the advice to patients is unclear. The aim of this paper is to identify the current evidence regarding pregnancy outcomes following exposure to biological therapy during pregnancy for the treatment of axSpA. Methods Methods: A literature search was conducted through Ovid Medline and Embase to identify relevant studies in line with a patient population, intervention, comparator, and outcomes (PICO) model identified prior to this study. An adapted version of the PRISMA 2020 flow diagram guided screening of manuscripts identified during database searches. Data gathered were summarised in a narrative review. Results From 15,121 papers identified, 101 were assessed for eligibility and six full papers were included in this study. Five of these studies reported 117 pregnancy outcomes following exposure to TNF-alpha inhibitors (adalimumab, etanercept, certolizumab pegol) for treatment of axSpA during pregnancy. Of these, five pregnancies were reported to have birth defects, for example cerebral ventricle dilatation and premature birth. The final study reported a high proportion of Caesarean sections among women treated with TNF-alpha inhibitors: 83 deliveries (61%) from 136 pregnancies. Conclusion There is very little published evidence on the safety of TNF-alpha inhibitors during pregnancy for axSpA and no papers were identified describing pregnancy outcomes in non-TNF biologics. Some additional literature was identified, examining biologic use in pregnancy across a variety of other rheumatological conditions, although it was often not possible to extract data on axSpA separately. However, existing evidence suggests no increased risk of adverse pregnancy outcomes associated with TNF inhibition in axSpA. There is some evidence that pregnant women may be more likely to undergo Caesarean section rather than vaginal delivery, although it is not clear whether this is due to increased elective or emergency Caesarean section. This review highlights the need for more studies to be conducted on this topic. This would enable more robust evidence-based guidelines to be produced and implemented confidently in clinical practice. Funding Statement: ELB supported by University of Aberdeen Summer Research Scholarship Programme. Disclosure E.L. Brandie: None. G.T. Jones: None.

Etanercept in axial spondyloarthritis – treatment efficacy

The beginning of the 21st century was marked by a simultaneous changes in view on pathogenesis, diagnostics and treatment of axial spondyloarthritis (axSpA). Anti-TNFα inhibitors were the first biologics prescribed in axSpA. 20 year after the biological treatment was first prescribed we have enough data to understand their long-term efficacy.The aim of this study is to evaluate the long-term efficacy of etanercept in patients with axial spondyloarthritis based on data published in periodicals and clinical practice.Patients and methods. An analysis of publications from medical database and data from the St. Petersburg register of patients with rheumatic diseases (n=68) was performed to assess the effectiveness of etanercept in axSpA treatment in the long-term perspectives. Descriptive statistics methods were used.Results. In clinical studies and in real word practice, etanercept has shown high efficiency in reducing clinical, laboratory and visual manifestations of non-radiographic and radiographic axial spondyloarthritis at early and advanced stages of their development.Conclusions. In the long term, the use of etanercept is associated with an increasing slowdown in structural progression while maintaining a stable clinical and laboratory improvement. Discontinuation of treatment in the majority of patients leads to exacerbation of axSpA. At the same time, the low immunogenicity of etanercept allows the resumption of axSpA treatment with a high probability of re-achieving the lost effect with a low probability of secondary ineffectiveness or anaphylaxis.

Anxiety and depression among patients with axial spondyloarthritis.

The axial spondyloarthritis (axSpA) mainly affects young population and often leads to reduced mobility, but less is known about the impact it has on mental health. The objective of this study was to determine the prevalence of symptoms of anxiety and depression among axSpA patients and explore the underlying associated factors. A cross sectional survey-based study was conducted from a single center. A convenient sampling was done to include 100 patients. We included questions about disease activity, sleep, fatigue, quality of life (QoL), and work productivity. All patients were asked to fill the patient health questionnaire-9 (PHQ) for depression and general anxiety disorder-7 (GAD) for anxiety. A multivariate binomial logistic regression analysis was performed to determine associations between PHQ-9 and GAD-7 scores with various socio-demographic factors, disease activity scores, and other variables. Clinically significant symptoms of anxiety and depression were present in 38% and 36% patients, respectively. Both were significantly associated with younger age at disease onset (P < .05), high disease activity, sleep disturbances, fatigue, poor QoL, and high impact on work productivity. Misbeliefs that "doctors hide side-effects of medicines" and "all modern medicine used in treatment of axSpA causes side-effects" were also related to higher anxiety and depression scores. Depression was also found to be associated with female patients. Anxiety and depression are common in axSpA. They are associated with high disease activity and reduced work productivity. Patients should be regularly screened for these symptoms.

Anti-IL-17 Agents in the Treatment of Axial Spondyloarthritis.

Axial spondyloarthritis (axSpA) describes a group of chronic inflammatory rheumatic diseases primarily involving the axial skeleton. IL-17 is involved in the pathogenesis of numerous inflammatory diseases, including inflammatory arthritis. Until a few years ago, the only biological agents licensed for the treatment of axSpA and nr-axSpA were TNF inhibitors. However, as some patients did not respond to TNF inhibition or experienced secondary failure, the introduction of the first two IL-17 inhibitors (secukinumab [SEC] and ixekizumab [IXE]) has extended the treatment options, and there are now three others (bimekizumab, brodalumab and netakimab) in various stages of clinical development. The last ten years have seen the development of a number of therapeutic recommendations that aimed at improving the management of axSpA patients. The aim of this narrative review of the published literature concerning the role of IL-17 in the pathogenesis of SpA, and the role of IL-17 inhibitors in the treatment of axSpA, is to provide a comprehensive picture of the clinical efficacy and safety of the drugs themselves, and the treatment strategies recommended in the international guidelines.

Brazilian recommendations for the use of nonsteroidal anti-inflammatory drugs in patients with axial spondyloarthritis

Spondyloarthritis (SpA) is a group of chronic inflammatory systemic diseases characterized by axial and/or peripheral joints inflammation, as well as extra-articular manifestations. Over some decades, nonsteroidal anti-inflammatory drugs (NSAIDs) have been the basis for the pharmacological treatment of patients with axial spondyloarthritis (axSpA). However, the emergence of the immunobiologic agents brought up the discussion about the role of NSAIDs in the management of these patients. The objective of this guideline is to provide recommendations for the use of NSAIDs for the treatment of axSpA. A panel of experts from the Brazilian Society of Rheumatology conducted a systematic review and meta-analysis of randomized clinical trials for 15 predefined questions. The Grading of Recommendations, Assessment, Development and Evaluation methodology to assess the quality of evidence and formulate recommendations were used, and at least 70% agreement of the voting panel was needed. Fourteen recommendations for the use of NSAIDs in the treatment of patients with axSpA were elaborated. The purpose of these recommendations is to support clinicians’ decision making, without taking out his/her autonomy when prescribing for an individual patient.

Therapeutic exercises and rehabilitation in axial spondyloarthropathy: Balancing benefits with unique challenges in the Asia-Pacific countries.

The burden of axial spondyloarthropathy (axSpA) in the Asia-Pacific region is substantial. The management of axSpA has been revolutionized with the advent of biological therapy where the disease activity, functional disability and negative psychological affect can be mitigated to a great extent. On the other hand, exercise remains an essential component of the treatment of axSpA at all stages, which is often discounted or underused. This is compounded by a gap in demand and supply between increasing number patients with axSpA and paucity of trained specialists and rehabilitation personnel in the Asia-Pacific countries. The acceptability and uptake of therapeutic exercise is strikingly poor in this region because of multiple factors such as lack of awareness among health professionals and the general population, poor healthcare infrastructure, lack of resources and limited accessibility to rehabilitation services. Health authorities and professional bodies in these countries need to work in tandem to expand healthcare facilities, encourage training opportunities and promote safe and effective exercise interventions which is accessible to the general population and individuals with axSpA. Adequate patient education, optimum control of disease activity and strict adherence to therapeutic exercise is essential to predict the best clinical outcome. In this narrative review we have appraised the impact of therapeutic exercise in this era of biological therapies in axSpA and have explored the challenges of rehabilitation services in the Asia-Pacific countries. Overall, the available quality of evidence is mixed, acknowledging the beneficial role of exercise and optimum usage and protocols pertaining to axSpA specific exercises and therefore further research is warranted.

The treatment journey for patients with axial spondyloarthritis in North Africa and the Middle East: From diagnosis to management.

The management of axial spondyloarthritis (axSpA) is challenging worldwide, and the particular challenges shared by North Africa and the Middle East are mainly related to early diagnosis and standardized management. We believe there are several reasons for these challenges, including: (a) limited awareness of the disease manifestations and prevalence in the region among physicians; (b) the concept of nonradiographic axSpA, while accepted with some difficulty by the rheumatology community, may not be well understood by the referring primary care physicians; (c) access to, and training in magnetic resonance imaging varies greatly between countries in the North Africa and Middle East region, and this may have a large impact on early diagnosis; (d) country‐specific treatment guidelines are unavailable; and (e) economic and cultural factors influence patients’ attempts to seek and continue treatment. In this review, we will discuss the prevalence of axSpA in North Africa and the Middle East, as well as the challenges to diagnose and treat patients in this region. As rheumatologists practicing in North Africa and the Middle East, we also provide suggestions to assist physicians, other healthcare professionals, and researchers in facilitating early, accurate diagnosis and treatment of axSpA.

Axial Spondyloarthritis in the Era of Precision Medicine.

In axial spondyloarthritis (axSpA), the first treatment step is generally a nonsteroidal anti-inflammatory drug, and if insufficient, a biologic is added. Currently, most evidence is available of the biologic tumor necrosis factor-α inhibitors. In patients who have achieved sustained low disease activity, tumor necrosis factor-α inhibitor tapering is considered, although standardized tapering schedules are lacking. In axSpA patients with extra-articular manifestations, the effect of axSpA treatment on these extra-articular manifestations is important to determine the preferred therapy. Overall, it is recommended that treatment of axSpA be individualized based on the most prominent symptoms and presence of extra-articular and peripheral symptoms.

The Future of Axial Spondyloathritis Treatment.

Axial spondyloathritis (axSpA) treatment with biologic DMARDs was previously focused around anti-TNF agents. Significant advances in research have led to new therapeutic options, such as secukinumab, an IL-17 inhibitor, which has been approved for the treatment of axSpA. Two other biologic agents that are already licensed for rheumatoid and psoriatic arthritis, tofacitinib and ixekizumab, have demonstrated improved outcomes in axSpA. Several newer agents have been developed to inhibit IL-17, IL-23, and JAK. Early trials are promising; however, further research is needed. Rapid expansion of therapies available to treat axSpA could lead to improved disease control and decreased disease burden.

New Insights in Physical Therapy and Rehabilitation in Axial Spondyloarthritis: A Review.

Axial spondyloarthritis (axSpA) is a chronic and inflammatory rheumatic disease characterized by pain, structural and functional impairments, and reduced mobility and potential deformity of the axial skeleton. Treatment of axSpA includes pharmacological and non-pharmacological therapy. However, in the biologic era, unmet needs still remain for patients intolerant to or non-responders to biologic drugs and despite the development of new treatments, physical therapy and rehabilitation are of crucial importance in the management of axSpA patients. The aim of this manuscript is to review the current evidence on the assessment, physical therapy, and rehabilitation in axSpA patients.

Health care and disease burden in persons with axial spondyloarthritis in Germany

Only very few data are available on the comprehensive care in patients with axial spondylarthritis (axSpA), one of the most frequent inflammatory rheumatic disease. Description of the comprehensive care and common prescription patterns of medications and other therapies in patients with axSpA depending on the type of medical care by rheumatologists or nonrheumatologists. Across-sectional analysis was performed based on claims data of the BARMER health insurance company (in 2015) and aquestionnaire, which was sent to arepresentative sample of patients with axSpA (International Classification of Diseases, 10th revision, German modification, ICD-10-GM, code M45) aged 18-79years. Astratified sample of 5000 patients was used. The patients received apostal questionnaire including questions regarding the disease, health-related and psychological parameters and socioeconomic factors. Claims data consisted of demographic factors, medicinal and nonmedicinal treatment and the extra-articular manifestations inflammatory bowel disease, psoriasis and uveitis. Atotal of 1741 patients (mean age 55.9years, female 46.4%, 86.2% Human Leucocyte Antigen[HLA]-B27 positive) confirmed the diagnosis and answered the questionnaire. The mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 4.5 and the mean Bath Ankylosing Spondylitis Functional Index (BASFI)4.1. Of the patients 46% were treated by rheumatologists. There was asubstantial difference between patients in rheumatological care and those who were not in rheumatological care regarding prescriptions for drug treatment of axSpA (91.8% versus 66.4%). This difference was especially prominent for prescriptions of biologic disease-modifying antirheumatic drugs: 34.1% of patients in rheumatological care versus 3.1% of patients treated by nonrheumatologists (p < 0.0001), despite similar disease activity in both groups. The data show that the majority of patients diagnosed with axSpA did not receive regular care from rheumatologists. This seemed to be associated with insufficient medicinal care at least in some of these patients.

Spotlight on certolizumab pegol in the treatment of axial spondyloarthritis: efficacy, safety and place in therapy.

Certolizumab pegol (CZP) is a pegylated humanized tumor necrosis factor-α inhibitor (TNFi) approved for the treatment of ankylosing spondylitis (AS) in the USA and for AS and non-radiographic axial spondyloarthritis (nr-axSpA) in Europe and in some Latin American countries. CZP lacks Fc region, preventing complement fixation and cytotoxicity mediated by antibody; CZP does not actively cross the placenta, unlike other TNFi. RAPID-axSpA study is a Phase III trial conducted in patients with AS and nr-axSpA as double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Of a total of 325 patients recruited, 107 patients were assigned to placebo and 218 patients to CZP (111 to CZP 200 mg Q2W, 107 to CZP 400 mg Q4W). Improvements in axial involvement, joint involvement, enthesitis and quality of life were reported in patients treated with CZP. Safety profile was like that reported for other TNFi in axSpA patients. In this article, we summarized the pharmacology and we reviewed the efficacy and tolerability of this drug for the treatment of axSpA. Some special considerations of CZP during pregnancy are included. CZP, the latest TNFi to be approved, showed efficacy in all manifestations of AS and nr-axSpA.

Should axial spondyloarthritis without radiographic changes be treated with anti-TNF agents?

A spectrum of disease extends beyond the rigid confines of ankylosing spondylitis (AS). Axial spondyloarthritis (axSpA) encompasses non-radiographic axSpA (nr-axSpA) in individuals without established radiographic changes but with other clinical/imaging axSpA features and AS in those with definite sacroiliac joint changes on pelvic X-rays. A broad consensus about the management of nr-axSpA is emerging among clinicians, but the evidence base remains open to question. To explore whether nr-axSpA and AS should be treated similarly, we examined the literature on their prevalence, natural history, disease burden, and treatment. There is strong evidence that nr-axSpA and AS are expressions of the same disease. Approximately 10% of patients with nr-axSpA will develop radiographic disease over 2years; after >20years, the figure may exceed 80%. Nr-axSpA patients have lower CRP and less spinal inflammation on MRI than AS patients but similar disease activity, pain, and quality-of-life impairment. Most patients with nr-axSpA manage well with conservative treatment, but a minority has severe disabling symptoms. Anti-TNF therapy has demonstrated similar efficacy and safety in nr-axSpA and AS. Current evidence does not clearly indicate that anti-TNF treatment can inhibit or limit bony progression of AS, the basis of conservative and anti-TNF treatment is control of symptoms and function. For some patients with nr-axSpA, the need for powerful treatments is as great as in some with AS; thus, treatment of axSpA should be consistent across the axSpA spectrum with anti-TNF agents being available, irrespective of radiographic change, according to the same criteria as those applied to AS.

Golimumab in radiographic and nonradiographic axial spondyloarthritis: a review of clinical trials.

Axial spondyloarthritis (Ax SpA) refers to chronic inflammatory rheumatic diseases that mainly affect the axial skeleton, leading to erosions and new bone formation in the sacroiliac joints and/or the spine. Ax SpA includes the radiographic form of the disease, ie, ankylosing spondylitis (AS), and the nonradiographic Ax SpA (non-Rx Ax SpA) forms. Anti-tumor necrosis factor alpha (TNFα) agents are used in the treatment of Ax SpA in patients who do not respond to or are intolerant to nonsteroidal anti-inflammatory drugs. In these patients, anti-TNFα agents show promising results by targeting the inflammatory process and providing symptomatic relief. Golimumab is a fully human anti-TNFα agent that is currently approved for the treatment of both AS and non-Rx Ax SpA in Europe. This review focuses on the results of clinical trials with golimumab for the treatment of AS (GO-RAISE studies) and non-Rx Ax SpA (GO-AHEAD study) and on the effects of this agent on imaging findings (radiographic progression, magnetic resonance imaging inflammation) as well as on biological parameters. Overall, golimumab is a valid therapeutic option in patients with AS and non-Rx Ax SpA in Europe.