Impact of the time of initiation and line of biologic therapy on the retention rate of secukinumab in axial spondyloarthritis (axSpA): data from the French multicentre retrospective FORSYA study.

OBJECTIVE: To compare the 1-year retention rate of secukinumab in axial spondyloarthritis (axSpA) and its predisposing factors with regard to its time of initiation (eg, right after or remotely from its launch). METHODS: Study design: Retrospective multicentre French study of patients with axSpA. Study periods: Two cohorts were evaluated regarding the time of initiation of secukinumab: cohort 1 (C1)-between 16 August 2016 and 31 August 2018-and cohort 2 (C2)-between 1 September 2018 and 13 November 2020. STATISTICAL ANALYSIS: The 1-year retention rate of secukinumab was estimated using the Kaplan-Meier method, and the log-rank test was used to compare the retention curves of the two cohorts. Preselected factors (eg, disease characterristics, line and time of secukinumab initiation) of secukinumab retention at 1 year were analysed by univariate and multivariate Cox model regression. RESULTS: In total, 906 patients in C1 and 758 in C2 from 50 centres were included in the analysis. The 1-year retention rate was better in C2 (64% (61%-68%)) vs C1 (59% (55%-62%)) (HR=1.19 (1.02-1.39); p=0.0297). In the multivariate analysis, the line of biologic therapy was the single predictive factor of the 1-year retention rate of secukinumab picked up in both cohorts, with a better retention rate when prescribed as first-line biologic therapy. CONCLUSION: The better secukinumab retention rate remotely from its launch is explained by its use at an earlier stage of the disease, suggesting a change in the behaviour of prescribing physicians. Our results emphasise the relevance of iterative evaluations of routine care treatments.

Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.

OBJECTIVE: To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities. METHODS: Prospective, randomized, controlled, open, 12-month trial (NCT02374749). PARTICIPANTS: consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group). MAIN OUTCOME: change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management). RESULTS: 502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). CONCLUSIONS AND RELEVANCE: This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.

Usefulness of polymerase chain reaction for diagnosing Whipple's disease in rheumatology.

OBJECTIVES: To determine when Tropheryma whipplei polymerase chain reaction (PCR) is appropriate in patients evaluated for rheumatological symptoms. METHODS: In a retrospective observational study done in rheumatology units of five hospitals, we assessed the clinical and radiological signs that prompted T. whipplei PCR testing between 2010 and 2014, the proportion of patients diagnosed with Whipple's disease, the number of tests performed and the number of diagnoses according to the number of tests, the patterns of Whipple's disease, and the treatments used. Diagnostic ascertainment was based on 1- Presence of at least one suggestive clinical finding; 2- at least one positive PCR test, and 3- a response to antibiotic therapy described by the physician as dramatic, including normalization of C Reactive Protein. RESULTS: At least one PCR test was performed in each of 267 patients. Rheumatic signs were peripheral arthralgia (n = 239, 89%), peripheral arthritis (n = 173, 65%), and inflammatory back pain (n = 85, 32%). Whipple's disease was diagnosed in 13 patients (4.9%). The more frequently positive tests were saliva and stool. In the centres with no diagnoses of Whipple's disease, arthritis was less common and constitutional symptoms more common. The group with Whipple's disease had a higher proportion of males, older age, and greater frequency of arthritis. The annual incidence ranged across centres from 0 to 3.6/100000 inhabitants. CONCLUSION: Males aged 40-75 years with unexplained intermittent seronegative peripheral polyarthritis, including those without constitutional symptoms, should have T. whipplei PCR tests on saliva, stool and, if possible, joint fluid.

Treatment of primary Sjögren syndrome.

Primary Sjögren syndrome (pSS) is a progressive autoimmune disease characterized by sicca and systemic manifestations. In this Review, we summarize the available data on topical and systemic medications, according to clinical signs and disease activity, and we describe the ongoing studies using biologic drugs in the treatment of pSS. Expanding knowledge about the epidemiology, classification criteria, systemic activity scoring (ESSDAI) and patient-reported outcomes (ESSPRI) is driving active research. Treatment decisions are based on the evaluation of symptoms and extraglandular manifestations. Symptomatic treatment is usually appropriate, whereas systemic treatment is reserved for systemic manifestations. Sicca is managed by education, environment modification, elimination of contingent offending drugs, artificial tears, secretagogues and treatments for complications. Mild systemic signs such as fatigue are treated by exercise. Pain can require short-term moderate-dose glucocorticoid therapy and, in some cases, disease-modifying drugs. Severe and acute systemic manifestations indicate treatment with glucocorticoids and/or immunosuppressant drugs. The role for biologic agents is promising, but no double-blind randomized controlled trials (RCTs) proving the efficacy of these drugs are available. Targets for new treatments directed against the immunopathological mechanisms of pSS include epithelial cells, T cells, B-cell overactivity, the interferon signature, proinflammatory cytokines, ectopic germinal centre formation, chemokines involved in lymphoid cell homing, and epigenetic modifications.

Evolution of direct costs in the first years of rheumatoid arthritis: impact of early versus late biologic initiation--an economic analysis based on the ESPOIR cohort.

OBJECTIVES: To estimate annual direct costs of early RA by resource component in an inception cohort, with reference to four distinct treatment strategies: no disease modifying antirheumatic drugs (DMARDs), synthetic DMARDs only, biologic DMARDs in the first year ('first-year biologic', FYB), and biologic DMARDs from the second year after inclusion ('later-year biologic', LYB); to determine predictors of total and non-DMARD related costs. METHODS: The ESPOIR cohort is a French multicentric, prospective study of 813 patients with early arthritis. Data assessing RA-related resource utilisation and disease characteristics were collected at baseline, biannually during the first two years and annually thereafter. Costs predictors were determined by generalised linear mixed analyses. RESULTS: Over the 4-year follow-up, mean annual direct total costs per treatment strategy group were €3,612 for all patients and €998, €1,922, €14,791, €8,477 respectively for no DMARDs, synthetic DMARDs only, FYB and LYB users. The main predictors of higher costs were biologic use and higher Health Assessment Questionnaire (HAQ) scores at baseline. Being a biologic user led to a higher total cost (FYB Rate Ratio (RR) 7.22, [95% CI 5.59-9.31]; LYB RR 4.39, [95% CI 3.58-5.39]) compared to non-biologic users. Only LYB increased non-DMARD related costs compared to all other patients by 60%. CONCLUSIONS: FYB users incurred the highest levels of total costs, while their non-DMARD related costs remained similar to non-biologic users, possibly reflecting better RA control.

High pain catastrophizing scores in one-fourth of patients on biotherapy for spondylarthritis or rheumatoid arthritis.

OBJECTIVES: To measure catastrophizing scores in patients on biotherapy for spondyloarthritis (SpA) or rheumatoid arthritis (RA). METHODS: The first 140 outpatients or day-hospital patients seen at a teaching hospital rheumatology department for biotherapy administration completed the validated French version of the Pain Catastrophizing Scale (PCS, total score ranging from 0 to 52); a questionnaire on perceived support and past, current, and future disease activity; and a questionnaire on perceived understanding of their disease by family and co-workers. RESULTS: PCS scores were significantly higher in the 54 SpA patients than in the 86 RA patients (20.8 ± 12.1 versus 17.0 ± 13.6; P = 0.08), as a result of a higher helplessness subscore (10.0 ± 6.2 versus 7.8 ± 6.2; P = 0.046). The PCS score was ≥30 in 14/54 (26%) SpA patients and in 19/86 (22%) RA patients; physicians identified catastrophizing in only 17 of these 33 patients. PCS scores showed moderate correlations with the AS-DAS and DAS-28 and slightly stronger correlations with the overall pain score (Pearson, +0.431; P = 0.0001). SpA patients reported significantly worse understanding by their co-workers than did RA patients (33.9 ± 33.4 versus 53.9 ± 36.3; P = 0.007). CONCLUSION: One-fourth of patients with SpA or RA had very high pain catastrophizing scores despite biotherapy. Pain catastrophizing was missed by the physicians in half the cases and was relatively independent from other follow-up parameters. Pain catastrophizing can jeopardize treatment outcomes and deserves specific management.

Incidence and nature of karate injuries.

OBJECTIVES: To determine the incidence and nature of karate injuries sustained in karate clubs and to identify risk factors for injuries. METHODS: One hundred eighty-six individuals from three karate clubs in Brest, France, were entered in a retrospective study extending from September 2002 to June 2003. Each athlete was asked to complete a questionnaire on karate injuries sustained during the previous year (type, location, mechanism, exercise during which the injury occurred, number of days off training and work, and medical care). Injury types were described by number of injuries and risk factors per number of injured athletes. RESULTS: Forty-eight (28.8%) of the 186 athletes sustained 83 injuries (63 while training and 20 while competing). The annual injury rate was 44.6 per 100 athletes. Incidence rates were similar in males and females and across the three clubs but increased with age, time spent training (3.6+/-1.7 vs. 2.9+/-1.5 h/week; P=0.001), rank (lower ranks vs. brown and black belts, P=0.015), and years of practice (7.3+/-5.5 years in athletes with injuries vs. 5.1+/-4.8 in those without injuries; P=0.03). Injuries consisted of 43 (53%) hematomas, 16 (19%) sprains, seven (7%) muscle lesions, six (7%) fractures, four (5%) malaise episodes, and seven (7%) miscellaneous lesions. Time off training occurred for 26 (31.3%) injuries and ranged from 8 to >30 days. The body region involved was the head in 22 (26.5%) injuries, the torso in eight injuries (9.6%), the upper limb in 24 (28.9%) injuries, and the lower limb in 29 (35%) injuries. CONCLUSION: Karate injuries are fairly common but usually minor. They are more likely to occur during competitions than while training. The head and limbs are the main regions involved. Longer training times per week and higher rank are associated with an increased risk of injury. Prevention seems crucial.