[Development of quality standards for patients with axial spondyloarthritis for use in Germany]. / Entwicklung von Qualitätsstandards für Patient*innen mit axialer Spondyloarthritis zum Einsatz in Deutschland.

Quality standards (QS) are measurable constructs designed to quantify gaps in care and subsequently to improve quality of care. The Assessment of SpondyloArthritis International Society (ASAS) recently generated and published international QS for the management of patients with axial spondyloarthritis (axSpA) for the first time. The German Society of Rheumatology (DGRh) then decided to translate, review and possibly adopt these standards by a group of experts from different care settings. Against this background, national QS for the management of patients with axSpA for Germany were developed for the first time. The main focus was on feasibility and practical relevance. Ultimately, nine QS were defined with which the quality of care in Germany can and should be measured and improved.

[Pathogenesis of spondylarthritis : Relevance for treatment]. / Pathogenese der Spondyloarthritiden : Relevanz für die Therapie.

Although the pathogenesis of spondylarthritis (SpA) has been the subject of intensive research in recent years, the consequences for treatment are relatively minor. Basic research studies indicated a potentially important role of the cytokines tumor necrosis factor (TNF) alpha and interleukin (IL)-17 for the pathogenesis of SpA but their outstanding role could then only be demonstrated by their inhibition in clinical studies, while other promising targets, such as IL­23 and IL­6 could not be shown to be relevant (at least against axial manifestations) in clinical studies. The intestinal microbiota probably plays an important role in the pathogenesis but not yet for the treatment of SpA. Ultimately, early effective and long-term suppression of inflammation is currently the best method to prevent ankylosis in the long run.

[Is it possible to delegate medical services to qualified nurses specialized in rheumatology when evaluating patients with suspicion of ankylosing spondylitis?-Results of the PredAS study]. / Ist eine Delegation ärztlicher Leistungen auf rheumatologische Fachassistenten bei der Evaluierung von Patienten mit Verdacht auf ankylosierende Spondylitis möglich? ­ Ergebnisse der PredAS-Studie.

BACKGROUND: The often slow onset of ankylosing spondylitis (AS), the initially partially unspecific symptoms (back pain) and the scarcity of resources in rheumatological care are important factors leading to delayed diagnosis and treatment of these mostly young patients in Germany. Qualified nurses specialized in rheumatology might improve quality of care by providing medical services delegated by the rheumatologists. OBJECTIVE: The aim was to investigate whether qualified nurses specialized in rheumatology can interpret anamnestic and clinical findings such as rheumatologists in patients with chronic low back pain and still unclear diagnosis using a structured questionnaire. MATERIAL AND METHODS: In the multicenter PredAS study a structured anamnestic questionnaire was applied independently by qualified nurses specialized in rheumatology and rheumatologists to patients referred to rheumatology practices with the leading symptom of low back pain. The questionnaire covered basic demographic data, medical history and patient reported outcomes. Additionally, measurements of physical function using the Bath ankylosing spondylitis functional index (BASFI) and spinal mobility using the Bath ankylosing spondylitis metrology index (BASMI) were standardized. In order to test the possible facilitation by using digital media, the results of two patient groups were separately documented on paper-based report forms and on an i­pad. Concordance between documentation by qualified nurses specialized in rheumatology and rheumatologists was studied by calculating Cohen's kappa, intraclass correlation coefficients (ICC) and percentage agreement on an individual patient level. RESULTS: Nearly 75% of the 141 patients with chronic low back pain were identified as having the characteristics of inflammatory back pain. The concordance of the documentation for the anamnesis of back pain by qualified nurses specialized in rheumatology and physicians was higher than for the localization of the back pain. The results for the BASMI showed no differences between qualified nurses specialized in rheumatology and physicians (ICC 0.925, 95 % confidence interval, CI 0.879-0.953). The time taken for the structured documentation was 20 ± 6.7 min for physicians and 28.5 ± 13 min for qualified nurses specialized in rheumatology. CONCLUSION: The results indicate that well-trained qualified nurses specialized in rheumatology have a high potential to take over some of the workload from rheumatologists during documentation of the anamnesis and the initial physical examination in the diagnosis of ankylosing spondylitis.

[Cost of illness in axial spondylarthritis for patients with and without tumor necrosis factor inhibitor treatment: results of a routine data analysis]. / Krankheitskosten bei axialer Spondyloarthritis für Patienten mit und ohne Tumor-Nekrose-Faktor-Inhibitor-Behandlung: Ergebnisse einer Routinedatenanalyse.

BACKGROUND: Tumour necrosis factor-alpha inhibitors (TNFi) are an effective but expensive treatment option in axial spondylarthritis (axSpA) patients who fail to achieve disease control under conventional treatment. OBJECTIVE: The aim of this study was to assess the cost of illness in axSpA patients treated with and without TNFi. METHODS: Using German health insurance data, patients with axSpA who newly received TNFi between 2011 and 2015 were identified and matched by age and sex to a reference group of patients with axSpA without TNFi treatment. Costs for services performed in an outpatient setting, inpatient care, pharmacotherapy and for productivity loss due to absence from paid work were analyzed over a 2-year period. In patients treated with TNFi , the 2­year period included 1 year before and 1 year after the initiation of TNFi. RESULTS: Data from 1455 axSpA patients who received TNFi treatment were included in the analyses. Costs for services performed in an outpatient setting, inpatient care, pharmacotherapy (excluding TNFi) as well as productivity loss significantly decreased after initiation of TNFi. Mean total costs increased from €â€¯6075 in the year prior to TNFi initiation to €â€¯27,871 in the year after TNFi initiation. Excluding costs for TNFi, total costs decreased by 22% to €â€¯4761. Mean total costs among the reference group of 1455 age and sex-matched axSpA patients who did not receive TNFi remained stable over 2 years: €â€¯3939 in the first year vs. €â€¯3832 in the second year. CONCLUSION: Initiation of TNFi treatment led to a sharp increase in the total costs of axSpA patients. Part of this increase was offset by a decrease of costs for services performed in an outpatient setting, inpatient care, pharmacotherapy (excluding TNFi) as well as productivity loss. In patients who did not receive TNFi, the costs remained stable over 2 years.

[Health care and disease burden in persons with axial spondyloarthritis in Germany]. / Gesundheitsversorgung und Krankheitslast bei Personen mit axialer Spondyloarthritis in Deutschland.

BACKGROUND: Only very few data are available on the comprehensive care in patients with axial spondylarthritis (axSpA), one of the most frequent inflammatory rheumatic disease. OBJECTIVE: 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. METHODS: A cross-sectional analysis was performed based on claims data of the BARMER health insurance company (in 2015) and a questionnaire, which was sent to a representative sample of patients with axSpA (International Classification of Diseases, 10th revision, German modification, ICD-10-GM, code M45) aged 18-79 years. A stratified sample of 5000 patients was used. The patients received a postal 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. RESULTS: A total of 1741 patients (mean age 55.9 years, 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 a substantial 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. CONCLUSION: 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.

[Evidence-based recommendations on diagnostics and therapy of axial spondyloarthritis : S3 guidelines of the German Society of Rheumatology (DGRh) in cooperation with the Association of the Scientific Medical Societies in Germany (AWMF)]. / Evidenzbasierte Empfehlung zur Diagnostik und Therapie der axialen Spondyloarthritis : S3-Leitlinie der Deutschen Gesellschaft für Rheumatologie (DGRh) in Kooperation mit der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF).

The clinical course of axial spondyloarthritis (SpA) is variable and characterized by chronic back pain and extraspinal manifestations, such as asymmetrical arthritis, dactylitis and enthesitis. Extra-articular manifestations in the eyes (anterior uveitis), skin (psoriasis) and intestines (chronic inflammatory bowel disease) are also frequent manifestations in patients with SpA. Due to the heterogeneity of disease manifestations and the partial concentration on structural alterations in the sacroiliac joints visible in X­ray images, the diagnosis is often delayed for many years. An important step in the direction of improved early recognition of axial SpA was establishment of the Assessment of SpondyloArthritis International Society (ASAS) classification criteria published in 2009, which focused on the initally deep-seated back pain and chronicity in relatively young patients as well as the importance of magnetic resonance imaging and HLA B 27 determination in the early stages of the disease. In order to achieve the foundations for an effective and timely therapy of affected patients, in 2014 on the initiative of the German Society of Rheumatology, S3 guidelines on axial SpA including Bechterew's disease and early forms were formulated in cooperation with other specialist societies. This article gives an overview of the contents of the S3 guidelines on axial SpA.

European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update.

BACKGROUND: Since the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations. METHODS: A systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated. RESULTS: The updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used. CONCLUSIONS: These recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

[Treat-to-target (T2T) recommendation for patients with spondyloarthritis - translation into German]. / "Treat-to-target (T2T)" Empfehlungen für die Behandlung von Patienten mit Spondyloarthritis ­ Übersetzung ins Deutsche.

The management of patients with spondyloarthritis (SpA) has experienced a paradigm shift in recent years. This is true for the treatment of axial as well as peripheral manifestations. International treat to target (T2T) recommendations for SpA based on the T2T strategy have now also been published, which contain 5 higher level principles (A-E) in addition to the 15 recommendations. In order to make the recommendations known and to promote national distribution, German experts have now issued a translation of the T2T recommendations for SpA into German.

EULAR recommendations for the use of imaging in the diagnosis and management of spondyloarthritis in clinical practice.

A taskforce comprised of an expert group of 21 rheumatologists, radiologists and methodologists from 11 countries developed evidence-based recommendations on the use of imaging in the clinical management of both axial and peripheral spondyloarthritis (SpA). Twelve key questions on the role of imaging in SpA were generated using a process of discussion and consensus. Imaging modalities included conventional radiography, ultrasound, magnetic resonance imaging, computed tomography (CT), positron emission tomography, single photon emission CT, dual-emission x-ray absorptiometry and scintigraphy. Experts applied research evidence obtained from systematic literature reviews using MEDLINE and EMBASE to develop a set of 10 recommendations. The strength of recommendations (SOR) was assessed by taskforce members using a visual analogue scale. A total of 7550 references were identified in the search process, from which 158 studies were included in the systematic review. Ten recommendations were produced using research-based evidence and expert opinion encompassing the role of imaging in making a diagnosis of axial SpA or peripheral SpA, monitoring inflammation and damage, predicting outcome, response to treatment, and detecting spinal fractures and osteoporosis. The SOR for each recommendation was generally very high (range 8.9-9.5). These are the first recommendations which encompass the entire spectrum of SpA and evaluate the full role of all commonly used imaging modalities. We aimed to produce recommendations that are practical and valuable in daily practice for rheumatologists, radiologists and general practitioners.

In situ analysis of interleukin-6 expression at different sites of zygapophyseal joints from patients with ankylosing spondylitis in comparison to controls.

OBJECTIVES: Analysis of interleukin (IL)-6 serum levels in patients with ankylosing spondylitis (AS) has indicated that IL-6 might be a pro-inflammatory cytokine involved in AS. However, two placebo-controlled trials with monoclonal antibodies directed against the IL-6 receptor have failed to demonstrate the efficacy of the monoclonal humanized anti-human IL-6 receptor antibody over placebo for the treatment of symptoms of AS. In this study we conducted an in situ analysis of IL-6 expression at different sites of inflammation in zygapophyseal joints of patients with AS in comparison to osteoarthritis autopsy controls (CO). METHOD: Our immunohistochemical analysis involved 14 patients with AS, 12 autopsy controls (CO), and 11 patients with osteoarthritis (OA). Immunohistochemistry was performed to detect IL-6+ cells at five different sites: within subchondral bone marrow, fibrous tissue replacing subchondral bone marrow, hyaline cartilage, and the subchondral bone plate, and at entheseal sites. RESULTS: Apart from changes in subchondral bone marrow, no significant differences were observed at the sites analysed when comparing AS patients and controls. A significantly lower frequency of IL-6+ cells was evident in AS patients compared to controls (p = 0.0043). In addition, AS patients tended to have even lower percentages of IL-6+ cells than controls at subchondral bone plates and entheseal sites. A significantly lower number of IL-6 expressing cells was also seen within the fibrous tissue of AS compared to OA patients (p = 0.0237). CONCLUSIONS: This in situ analysis confirms that IL-6 is not a key player in the pathogenesis of inflammatory processes in spondyloarthritides (SpA). The relevance of pro-inflammatory agents in axial SpA might be studied better in situ in bony specimens at the primary site of inflammation.

[Enthesitis in connection with spondyloarthritides]. / Enthesitis im Rahmen von Spondyloarthritiden.

Enthesitis is a frequent manifestation in spondyloarthritis (SpA) and psoriatic arthritis (PsA) and can be found in up to 40% of patients with SpA. Because of the pathognomonic relevance the classification criteria for SpA and PsA use enthesitis as an entrance or secondary criterion. Enthesitis is most frequently localized at the heel but it can occur at any insertion of an enthesis into the bone. When diagnosing enthesitis differential diagnoses should be considered, mechanical-degenerative causes and fibromyalgia in particular should be excluded. The imaging techniques power Doppler ultrasound (PDUS) and magnetic resonance imaging (MRI) are most helpful in making the diagnosis. The therapeutic options for enthesitis are limited. Nonsteroidal antirheumatic drugs (NSARD) and local injections of corticosteroids are recommended. In small clinical trials no efficacy of disease modifying antirheumatic drugs (DMARD) could be demonstrated. In contrast, tumor necrosis factor alpha (TNF-alpha) blockers were shown to be highly effective in randomized controlled trials for SpA and PsA but they are not currently approved for enthesitis only.

[Enthesitis in the context of spondyloarthritides]. / Enthesitis im Rahmen von Spondyloarthritiden.

Enthesitis is a frequent manifestation in spondyloarthritis (SpA) and psoriatic arthritis (PsA) and can be found in up to 40 % of patients with SpA. Because of the pathognomonic relevance the classification criteria for SpA and PsA use enthesitis as an entrance or secondary criterion. Enthesitis is most frequently localized at the heel but it can occur at any insertion of an enthesis into the bone. When diagnosing enthesitis differential diagnoses should be considered, mechanical-degenerative causes and fibromyalgia in particular should be excluded. The imaging techniques power Doppler ultrasound (PDUS) and magnetic resonance imaging (MRI) are most helpful in making the diagnosis. The therapeutic options for enthesitis are limited. Nonsteroidal antirheumatic drugs (NSARD) and local injections of corticosteroids are recommended. In small clinical trials no efficacy of disease modifying antirheumatic drugs (DMARD) could be demonstrated. In contrast, tumor necrosis factor alpha (TNF-alpha) blockers were shown to be highly effective in randomized controlled trials for SpA and PsA but they are not currently approved for enthesitis only.

[Lessons learnt from 15 years of investigator-initiated trials on axial spondyloarthritis]. / Erfahrungen aus 15 Jahren Investigator-initiierten klinischen Studien zur axialen Spondyloarthritis.

BACKGROUND: Clinical research is receiving an increasing amount of attention and is essential for improving treatment of patients with rheumatic diseases. AIMS: This article reports on 15 years of experience with conducting investigator-initiated studies on axial spondyloarthritis including ankylosing spondylitis. RESULTS: We have organized and successfully conducted a series of open-labelled and placebo-controlled double-blind treatment studies and also non-interventional studies on this topic. The installation of a qualified and motivated trial unit and intensive collaboration with a statistician were crucial requirements for success. These results have increased our knowledge about the disease and changed and improved the diagnostic possibilities and the therapeutic options. CONCLUSION: Investigator-initiated trials are an important link between basic and clinical research and can substantially contribute to improvement of patient care. This kind of research should be more systematically funded in the future.

Efficacy of oral prednisolone in active ankylosing spondylitis: results of a double-blind, randomised, placebo-controlled short-term trial.

BACKGROUND: The efficacy of oral prednisolone in patients with active ankylosing spondylitis (AS) has not been studied to date. METHODS: In this double-blind, randomised, placebo-controlled trial, patients with AS with active disease despite taking non-steroidal antirheumatic drugs were randomised to three groups in which they were either treated with 20 mg (n=13) or 50 mg (n=12) of prednisolone, or placebo (n=14), administered orally every day for a total of 2 weeks. The primary endpoint was defined as a 50% improvement of the Bath AS Disease Activity Index (BASDAI) at week 2. RESULTS: The primary endpoint was reached in 33% and 27% of the patients treated with 50 and 20 mg of prednisolone, respectively, versus only 8% on placebo (p=0.16 and p=0.30). However, the mean improvement of BASDAI score was significantly higher in the 50 mg prednisolone compared to the placebo group (2.39±0.5 vs 0.66±0.49, p=0.03), while there was only a small change in the 20 mg group (1.19±0.53; p=0.41). The results for other outcome parameters were similar. CONCLUSIONS: Oral prednisolone 50 mg per day, but not low dose prednisolone, showed a short-term response that was significantly higher than placebo. The clinical significance and the duration of this effect warrant further study.

Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1.

OBJECTIVES: To assess whether combination therapy with infliximab (IFX) plus nonsteroidal anti-inflammatory drugs (NSAIDs) is superior to NSAID monotherapy for reaching Assessment of SpondyloArthritis international Society (ASAS) partial remission in patients with early, active axial spondyloarthritis (SpA) who were naïve to NSAIDs or received a submaximal dose of NSAIDs. METHODS: Patients were randomised (2 : 1 ratio) to receive naproxen (NPX) 1000 mg daily plus either IFX 5 mg/kg or placebo (PBO) at weeks 0, 2, 6, 12, 18 and 24. The primary efficacy measure was the percentage of patients who met ASAS partial remission criteria at week 28. Several other measures of disease activity, clinical symptoms and patient-rated outcomes were evaluated. Treatment group differences were analysed with Fisher exact tests or analysis of covariance. RESULTS: A greater percentage of patients achieved ASAS partial remission in the IFX+NPX group (61.9%; 65/105) than in the PBO+NPX group (35.3%; 18/51) at week 28 (p=0.002) and at all other visits (p<0.05, all comparisons). Results of most other disease activity and patient-reported endpoints (including Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, multiple quality of life measures and pain measures) showed greater improvement in the IFX+NPX group than the PBO+NPX group, with several measures demonstrating early and consistent improvement over 28 weeks of treatment. CONCLUSIONS: Patients with early, active axial SpA who received IFX+NPX combination treatment were twice as likely to achieve clinical remission as patients who received NPX alone. NPX alone led to clinical remission in a third of patients.

Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2.

OBJECTIVE: To investigate whether biologic-free remission can be achieved in patients with early, active axial spondyloarthritis (SpA) who were in partial remission after 28 weeks of infliximab (IFX)+naproxen (NPX) or placebo (PBO)+NPX treatment and whether treatment with NPX was superior to no treatment to maintain disease control. METHOD: Infliximab as First-Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial (INFAST) Part 1 was a double-blind, randomised, controlled trial in biologic-naïve patients with early, active, moderate-to-severe axial SpA treated with either IFX 5 mg/kg+NPX 1000 mg/d or PBO+NPX 1000 mg/d for 28 weeks. Patients achieving Assessment of SpondyloArthritis international Society (ASAS) partial remission at week 28 continued to Part 2 and were randomised (1:1) to NPX or no treatment until week 52. Treatment group differences in ASAS partial remission and other efficacy variables were assessed through week 52 with Fisher exact tests. RESULTS: At week 52, similar percentages of patients in the NPX group (47.5%, 19/40) and the no-treatment group (40.0%, 16/40) maintained partial remission, p=0.65. Median duration of partial remission was 23 weeks in the NPX group and 12.6 weeks in the no-treatment group (p=0.38). Mean Bath Ankylosing Spondylitis Disease Activity Index scores were low at week 28, the start of follow-up treatment (NPX, 0.7; no treatment, 0.6), and remained low at week 52 (NPX, 1.2; no treatment, 1.7). CONCLUSIONS: In axial SpA patients who reached partial remission after treatment with either IFX+NPX or NPX alone, disease activity remained low, and about half of patients remained in remission during 6 months in which NPX was continued or all treatments were stopped.

Autoantibodies against CD74 in spondyloarthritis.

BACKGROUND: Spondyloarthritis (SpA) is a common debilitating inflammatory disorder. Establishing the diagnosis is often difficult, since abnormalities in conventional X-ray develop with a latency of several years and only HLA-B27 is used as a laboratory marker. The goal of our study was to identify new autoantibodies as diagnostic markers of SpA. METHODS: Protein array technology was used to screen for new autoantigens in ankylosing spondylitis. Then, the results were confirmed by ELISA using Class II-associated invariant chain peptide domain of CD74 as antigen. Sera for the ELISA were obtained from 216 patients with axial (n=156) and peripheral (n=60) SpA. Sera of patients with psoriatic arthritis without axial involvement as another subtype of peripheral SpA, rheumatoid arthritis, systemic lupus erythematosus, HIV infection and blood donors served as controls. All donors provided informed consent for the study which was approved by the local ethics committee (project number 4928). RESULTS: Using protein arrays, we detected IgG antibodies against CD74 in SpA sera. Using ELISA technology on sera that had previously been frozen for several years, IgG autoantibodies against CD74 were found in 67% of the SpA patients and were even more frequent in patients with a short disease duration. In the controls, the prevalence of the new autoantibodies was 18/40 (45%) in psoriatic arthritis without axial involvement, 9/80 (11%) in rheumatoid arthritis, 6/40 (15%) in systemic lupus erythematosus, 1/40 (2.5%) in HIV and 1/125 (0.8%) in blood donors. CONCLUSIONS: Antibodies against CD74 could provide an important additional tool for diagnosis of SpA.

Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study.

OBJECTIVES: To evaluate the efficacy and safety of certolizumab pegol (CZP) after 24 weeks in RAPID-axSpA (NCT01087762), an ongoing Phase 3 trial in patients with axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA). METHODS: Patients with active axSpA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). In total 325 patients were randomised. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society 20) response at week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear. RESULTS: Baseline disease activity was similar between AS and nr-axSpA. At week 12, ASAS20 response rates were significantly higher in CZP 200 mg Q2W and CZP 400 mg Q4W arms versus placebo (57.7 and 63.6 vs 38.3, p≤0.004). At week 24, combined CZP arms showed significant (p<0.001) differences in change from baseline versus placebo in BASFI (-2.28 vs -0.40), BASDAI (-3.05 vs -1.05), and BASMI (-0.52 vs -0.07). Improvements were observed as early as week 1. Similar improvements were reported with CZP versus placebo in both AS and nr-axSpA subpopulations. Adverse events were reported in 70.4% vs 62.6%, and serious adverse events in 4.7% vs 4.7% of All CZP versus placebo groups. No deaths or malignancies were reported. CONCLUSIONS: CZP rapidly reduced the signs and symptoms of axSpA, with no new safety signals observed compared to the safety profile of CZP in RA. Similar improvements were observed across CZP dosing regimens, and in AS and nr-axSpA patients.

Treating axial and peripheral spondyloarthritis, including psoriatic arthritis, to target: results of a systematic literature search to support an international treat-to-target recommendation in spondyloarthritis.

BACKGROUND: Current recommendations for the management of axial spondyloarthritis (SpA) and psoriatic arthritis are to monitor disease activity and adjust therapy accordingly. However, treatment targets and timeframes of change have not been defined. An international expert panel has been convened to develop 'treat-to-target' recommendations, based on published evidence and expert opinion. OBJECTIVE: To review evidence on targeted treatment for axial and peripheral SpA, as well as for psoriatic skin disease. METHODS: We performed a systematic literature search covering Medline, Embase and Cochrane, conference abstracts and studies in http://www.clinicaltrials.gov. RESULTS: Randomised comparisons of targeted versus routine treatment are lacking. Some studies implemented treatment targets before escalating therapy: in ankylosing spondylitis, most trials used a decrease in Bath Ankylosing Spondylitis Disease Activity Index; in psoriatic arthritis, protocols primarily considered a reduction in swollen and tender joints; in psoriasis, the Modified Psoriasis Severity Score and the Psoriasis Area and Severity Index were used. Complementary evidence correlating these factors with function and radiographic damage at follow-up is sparse and equivocal. CONCLUSIONS: There is a need for randomised trials that investigate the value of treat-to-target recommendations in SpA and psoriasis. Several trials have used thresholds of disease activity measures to guide treatment decisions. However, evidence on the effect of these data on long-term outcome is scarce. The search data informed the expert committee regarding the formulation of recommendations and a research agenda.