[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.

[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.

[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.

[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.

Spinal radiographic progression over 2 years in ankylosing spondylitis patients treated with secukinumab: a historical cohort comparison.

OBJECTIVE: The aim of this study was to compare radiographic progression in patients with ankylosing spondylitis (AS) treated for up to 2 years with secukinumab (MEASURE 1) with a historical cohort of biologic-naïve patients treated with NSAIDs (ENRADAS). METHODS: Baseline and 2-year lateral cervical and lumbar spine radiographs were independently evaluated using mSASSS by two readers, who were blinded to the chronology and cohort of the radiographs. The primary endpoint was the proportion of patients with no radiographic progression (mSASSS change ≤ 0 from baseline to year 2). The Primary Analysis Set included patients with baseline (≤ day 30) and post-baseline day 31-743 radiographs. Sensitivity analyses were performed to assess the robustness of the comparison between the two cohorts, as follows: Sensitivity Analysis Set 1 included all patients with baseline (≤ day 30) and year 2 (days 640-819) radiographs; Sensitivity Analysis Set 2 included all patients with baseline and post-baseline (> day 30) radiographs. RESULTS: A total of 168 patients (84%) from the MEASURE 1 cohort and 69 (57%) from the ENRADAS cohort qualified for the Primary Analysis Set. Over 2 years, the LS (SE) mean change from baseline in mSASSS for the primary analysis was 0.55 (0.139) for MEASURE 1 vs 0.89 (0.216) for ENRADAS (p = 0.1852). Mean changes from baseline in mSASSS were lower in MEASURE 1 vs ENRADAS for the primary and sensitivity analyses. The proportion of patients with no radiographic progression was consistently higher in the MEASURE 1 vs ENRADAS cohort across all cutoffs for no radiographic progression (change in mSASSS from baseline to year 2 of ≤ 0, ≤ 0.5, ≤ 1, and ≤ 2), but the differences were not statistically significant. CONCLUSION: Secukinumab-treated patients demonstrated a numerical, but statistically non-significant, higher proportion of non-progressors and lower change in mSASSS over 2 years versus a cohort of biologic-naïve patients treated with NSAIDs.

Secukinumab and Sustained Improvement in Signs and Symptoms of Patients With Active Ankylosing Spondylitis Through Two Years: Results From a Phase III Study.

OBJECTIVE: Secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) over 52 weeks in the phase III MEASURE 2 study. Here, we report longer-term (104 weeks) efficacy and safety results. METHODS: Patients with active AS were randomized to subcutaneous secukinumab 150 mg, 75 mg, or placebo at baseline; weeks 1, 2, and 3; and every 4 weeks from week 4. The primary end point was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response rate at week 16. Other end points included ASAS40, high-sensitivity C-reactive protein, ASAS5/6, Bath Ankylosing Spondylitis Disease Activity Index, Short Form 36 health survey physical component summary, ASAS partial remission, EuroQol 5-domain measure, and Functional Assessment of Chronic Illness Therapy fatigue subscale. End points were assessed through week 104, with multiple imputation for binary variables and a mixed-effects model repeated measures for continuous variables. RESULTS: Of 219 randomized patients, 60 of 72 (83.3%) and 57 of 73 (78.1%) patients completed 104 weeks of treatment with secukinumab 150 mg and 75 mg, respectively; ASAS20/ASAS40 response rates at week 104 were 71.5% and 47.5% with both secukinumab doses, respectively. Clinical improvements with secukinumab were sustained through week 104 across all secondary end points. Across the entire treatment period (mean secukinumab exposure 735.6 days), exposure-adjusted incidence rates for serious infections and infestations, Crohn's disease, malignant or unspecified tumors, and major adverse cardiac events with secukinumab were 1.2, 0.7, 0.5, and 0.7 per 100 patient-years, respectively. No cases of tuberculosis reactivation, opportunistic infections, or suicidal ideation were reported. CONCLUSION: Secukinumab provided sustained improvement through 2 years in the signs and symptoms of AS, with a safety profile consistent with previous reports.

[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.

Long-term efficiency of infliximab in patients with ankylosing spondylitis: real life data confirm the potential for dose reduction.

OBJECTIVE: To analyse the treatment outcome of patients with ankylosing spondylitis (AS) in the European AS infliximab cohort (EASIC) study after a total period of 8 years with specific focus on dosage and the duration of intervals between infliximab infusions. METHODS: EASIC included patients with AS who had received infliximab for 2 years as part of the ASSERT trial. After that period, rheumatologists were free to change the dose or the intervals of infliximab. Clinical data were status at baseline, end of ASSERT and for a total of 8 years of follow-up. RESULTS: Of the initially 71 patients with AS from EASIC, 55 patients (77.5%) had completed the 8th year of anti-tumour necrosis factor (TNF) treatment. Of those, 48 patients (87.3%) still continued on infliximab. The mean infusion interval increased slightly from 6 to 7.1±1.5 weeks, while 45.8% patients had increased the intervals up to a maximum of 12 weeks. The mean infliximab dose remained stable over time, with a minimum of 3.1 mg/kg and a maximum of 6.4 mg/kg. In patients receiving <5 mg/kg infliximab, the mean infusion interval increased to 7.0±1.2 weeks. In total, the mean cumulative dose per patient and per year decreased from 3566.30 to 2973.60 mg. CONCLUSIONS: We could observe that over a follow-up of 8 years of treatment with infliximab, >85% patients still remained on the same treatment, without any major safety events. Furthermore, both the infusion intervals and also the mean infliximab dose were modestly reduced in ≥70% of the patients without the loss of clinical efficiency.

[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.

Observed Incidence of Uveitis Following Certolizumab Pegol Treatment in Patients With Axial Spondyloarthritis.

OBJECTIVE: Axial spondyloarthritis (axial SpA) is characterized by inflammation of the spine and sacroiliac joints and can also affect extraarticular sites, with the most common manifestation being uveitis. Here we report the incidence of uveitis flares in axial SpA patients from the RAPID-axSpA trial, including ankylosing spondylitis (AS) and nonradiographic (nr) axial SpA. METHODS: The RAPID-axSpA (NCT01087762) trial is double-blind and placebo-controlled to week 24, dose-blind to week 48, and open-label to week 204. Patients were randomized to certolizumab pegol (CZP) or placebo. Placebo patients entering the dose-blind phase were re-randomized to CZP. Uveitis events were recorded on extraarticular manifestation or adverse event forms. Events were analyzed in patients with/without history of uveitis, and rates reported per 100 patient-years. RESULTS: At baseline, 38 of 218 CZP-randomized patients (17.4%) and 31 of 107 placebo-randomized patients (29.0%) had past uveitis history. During the 24-week double-blind phase, the rate of uveitis flares was lower in CZP (3.0 [95% confidence interval (95% CI) 0.6-8.8] per 100 patient-years) than in placebo (10.3 [95% CI 2.8-26.3] per 100 patient-years). All cases observed during the 24-week double-blind phase were in patients with a history of uveitis; in these patients, rates were similarly lower for CZP (17.1 [95% CI 3.5-50.1] per 100 patient-years) than placebo (38.5 [95% CI 10.5-98.5] per 100 patient-years). Rates of uveitis flares remained low up to week 96 (4.9 [95% CI 3.2-7.4] per 100 patient-years) and were similar between AS (4.4 [95% CI 2.3-7.7] per 100 patient-years) and nr-axial SpA (5.6 [95% CI 2.9-9.8] per 100 patient-years). CONCLUSION: The rate of uveitis flares was lower for axial SpA patients treated with CZP than placebo during the randomized controlled phase. Incidence of uveitis flares remained low to week 96 and was comparable to rates reported for AS patients receiving other anti-tumor necrosis factor antibodies.

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.

A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis.

OBJECTIVE: Axial spondyloarthritis (SpA) is a chronic inflammatory disease characterized by back pain and stiffness. The objective of this study was to determine whether golimumab is superior to placebo in patients with nonradiographic axial SpA. METHODS: This phase III, double-blind, randomized, placebo-controlled trial was performed to evaluate subcutaneous golimumab (50 mg) versus placebo in patients ages ≥18 years to ≤45 years who had active nonradiographic axial SpA according to the Assessment of SpondyloArthritis international Society (ASAS) criteria for ≤5 years since diagnosis, high disease activity, and an inadequate response to or intolerance of nonsteroidal antiinflammatory drugs. Patients were randomized 1:1 to receive golimumab or placebo subcutaneously every 4 weeks. The primary end point was 20% improvement according to the ASAS criteria (ASAS20) at week 16. Key secondary end points were an ASAS40 response, ASAS partial remission, 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and change in the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) index for sacroiliac (SI) joint inflammation (SPARCC score). RESULTS: Of the 198 patients randomized, 197 were treated (97 received golimumab, and 100 received placebo). The mean age of the patients was 31 years, and 57.1% were male. At baseline, the mean ± SD BASDAI was 6.5 ± 1.5, the mean ± SD ASDAS was 3.5 ± 0.9, and the mean ± SD SPARCC score was 11.3 ± 14.0. The primary end point, an ASAS20 response, was achieved by significantly more patients in the golimumab group compared with the placebo group (71.1% versus 40.0%; P < 0.0001). An ASAS40 response was also achieved by significantly more patients in the golimumab group compared with the placebo group (56.7% versus 23.0%; P < 0.0001). The incidence of adverse events did not differ meaningfully between groups. CONCLUSION: Patients with active nonradiographic axial SpA treated with golimumab had significantly greater improvement in symptoms compared with patients treated with placebo. Golimumab was well tolerated and had a favorable risk/benefit profile.

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.

Impact of Certolizumab Pegol on Patient-Reported Outcomes in Patients With Axial Spondyloarthritis.

OBJECTIVE: Patient-reported outcomes (PROs) provide an opportunity to collect important information relating to patient well-being, which is often difficult for physicians to measure (e.g., quality of life, pain, fatigue, and sleep). Here we evaluate the effects of certolizumab pegol (CZP) on PROs during the 24-week, double-blind phase of the RAPID axial spondyloarthritis (SpA) trial, a phase 3 trial of axial SpA patients, including both ankylosing spondylitis (AS) and nonradiographic axial SpA patients. METHODS: A total of 325 patients with active axial SpA were randomized 1:1:1 to placebo, CZP 200 mg every 2 weeks, or CZP 400 mg every 4 weeks. The primary end point was the Assessment of SpondyloArthritis International Society criteria for 20% improvement in disease activity response at week 12, and has been reported previously. PROs included total back pain, nocturnal back pain, a daily pain diary, the Sleep Problems Index II (SPI) domain of the Medical Outcomes Study (MOS) Sleep Scale, fatigue, the Ankylosing Spondylitis Quality of Life (ASQOL) measure, and the Short Form 36-item (SF-36) health survey physical component summary (PCS), mental component summary (MCS), and domains. RESULTS: Patients treated with CZP reported significant improvements from week 1 for nocturnal back pain (placebo -0.6, CZP 200 mg every 2 weeks -1.9, and CZP 400 mg every 4 weeks -1.6; P < 0.001) and ASQOL (placebo -1.0, CZP 200 mg every 2 weeks -2.3, and CZP 400 mg every 4 weeks -1.9; P < 0.05) compared with placebo, while significant improvements in total back pain were seen from day 2. Patients treated with both CZP dosing regimens also had significantly greater improvements in fatigue, MOS-SPI, SF-36 PCS, MCS, and domains compared with placebo. Improvements were similar in both AS and nonradiographic axial SpA patients. CONCLUSION: Both CZP dosing schedules rapidly improved patient well-being, as measured by PROs, including pain, fatigue, sleep, SF-36, and ASQOL in both AS and nonradiographic axial SpA patients.

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.