Canadian Adalimumab Post-Marketing Observational Epidemiological Study Effectiveness in Psoriatic Arthritis (COMPLETE-PsA): 12-Month Results of Comparative Effectiveness of Adalimumab and nbDMARDs

Objective COMPLETE-PsA was an observational study of biologic-naïve Canadian adults with active psoriatic arthritis (PsA) treated with adalimumab or a non-biologic disease-modifying antirheumatic drug (nbDMARDs) regimen, after inadequate response/intolerance to a current nbDMARD treatment regimen. The aim of this analysis was to assess 12-month effectiveness of adalimumab versus nbDMARDs. Methods Patients enrolled between March 2012 and November 2017 were included. The following clinical parameters and patient-reported outcomes were collected/calculated per routine care: DAPSA28, DAS28, ESR, CRP, MDGA, PtGA, pain, HAQ-DI, SF-12, enthesitis, dactylitis, BSA, and time to achieving ACR50, ACR70 and modified MDA (mMDA). Results Two hundred seventy-seven adalimumab-treated and 148 nbDMARD-treated patients were included. At baseline, adalimumab-treated patients were less likely to be employed; had longer morning stiffness; higher DAPSA28, DAS28, MDGA, PtGA, pain, and HAQ-DI; and lower prevalence of dactylitis (all p<0.05). Adalimumab-treated patients showed lower baseline-adjusted DAPSA28 (16.5 vs. 26.6), DAS28 (2.8 vs. 3.9), MDGA (25.3 vs. 37.1), and ESR (10.2 vs. 15.4 mm/hr) after 3 months compared to nbDMARD-treated patients, with observed improvements maintained to month 12. Time to achievement of ACR50, ACR70, and mMDA was significantly (p<0.01) shorter among adalimumab-treated patients, with the likelihood of having dactylitis [OR: 0.4 (0.2–0.6)] and BSA<3% [2.7 (1.5–5.0)] significantly lower and higher, respectively. Switching to another biologic was less likely in adalimumab-treated vs. nbDMARD -treated patients (HR [95% CI]: 0.3 [0.2-0.5]). Conclusion In a real-world Canadian PsA population, adalimumab was more effective than nbDMARDs at reducing disease activity and the severity of skin involvement and demonstrated higher retention.

Evaluating Comparing the Effects of Massage Therapy and Aromatherapy on Knee Pain, Morning Stiffness, Daily Life Function, and Quality of Life in Patients with Knee Osteoarthritis

Dear Editor, We are very happy to read this article named “Comparing the Effects of Massage Therapy and Aromatherapy on Knee Pain, Morning Stiffness, Daily Life Function, and Quality of Life in Patients with Knee Osteoarthritis” [1]. The study confirmed that massage can effectively improve the quality of life of patients with knee osteoarthritis. This provides clinicians with good health advice. We greatly appreciate the author’s research. If the research design can be improved, then the research power will be stronger. The authors used simple randomization for patient assignments. Although simple randomization is inexpensive and easy to implement, it is easy to trigger imbalances in terms of important baseline[2]. Furthermore, simple randomization may lead to i=imbalances in the number of participants randomized for each group [3]. In a small samples trial, simple randomization is not a good option for the trial. Blocked randomization may be a better choice for a small sample trial, for example, this study. On the other hand, authors should report the basis for the calculation of sample size according to the CONSORT statement [4]. The authors should consider the balance between medicine and statistics, which will be a bridge of scientific study and ethical requirements. The authors did not disclose how they determined the sample size, so we cannot evaluate whether the study reached a reasonable balance.

AYURVEDIC MANAGEMENT OF SYSTEMIC LUPUS ERYTHEMATOSUS

Systemic Lupus Erythematosus is a systemic autoimmune connective tissue disease. Arthralgia is a common symptom, occurring in 90% of patients, and is often associated with early morning stiffness. Considering symp- tomatology, In Ayurveda classics, it can be compared with amavata1. This is the case report of a female patient aged 19 years suffering from multiple joints pain associated with swelling and tenderness and finger deformities, Diagnosed as Systemic lupus erythematosus (SLE). Visited the Department of Panchakarma, SAMC&H, Banga- lore for the treatment. Virechana karma followed by Shamana Aushadhi was administered. Significant improve- ment in the signs and symptoms was observed clinically. Keywords: Systemic Lupus Erythematosus, SLE, Amavata, Virechana, Shamana Auaushadhi

Test–retest reliability of outcome measures: data from three trials in radiographic and non-radiographic axial spondyloarthritis

ObjectivesAim of this study was to assess test–retest reliability of candidate instruments for the mandatory domains of the Assessment of Spondyloarthritis international Society (ASAS)-Outcome Measures in Rheumatology core set for axial spondyloarthritis (axSpA).MethodsScreening and baseline data from COAST-V, COAST-X and RAPID-axSpA was used to evaluate test–retest reliability of each candidate instrument for the mandatory domains (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health). A maximum time interval of 28 days between both visits was used for inclusion in this study. Test–retest reliability was assessed by intraclass correlation coefficient (ICC). Bland and Altman plots provided mean difference and 95% limits of agreement, which were used to calculate the smallest detectable change (SDC). Data were analysed for radiographic and non-radiographic axSpA separately.ResultsGood reliability was found for Ankylosing Spondylitis Disease Activity Score (ICC 0.79, SDC 0.6), C reactive protein (ICC 0.72–0.79, SDC 12.3–17.0), Bath Ankylosing Spondylitis Functional Index (ICC 0.87, SDC 1.1) and 36-item Short-Form Health Survey (ICC Physical Component Summary 0.81, SDC 4.7, Mental Component Summary 0.80, SDC 7.3). Moderate reliability was found for Bath Ankylosing Spondylitis Disease Activity Index (ICC 0.72, SDC 1.1), patient global assessment (ICC 0.58, SDC 1.5), total back pain (ICC 0.64, SDC 1.3), back pain at night (ICC 0.67, SDC 1.3), morning stiffness (ICC 0.52–0.63, SDC 1.5–2.2), fatigue (ICC 0.65, SDC 1.3) and ASAS-Health Index (ICC 0.74, SDC 2.5). Reliability and SDC for the radiographic and non-radiographic axSpA subgroups were similar.ConclusionOverall reliability was good, and comparable levels of reliability were found for patients with radiographic and non-radiographic axSpA, even though most instruments were developed for radiographic axSpA. Composite measures showed higher reliability than single-item measures in assessing disease activity in patients with axSpA.

P018 Functional impairment in enthesitis related arthritis patients

Background Enthesitis related arthritis (ERA) is a subgroup of juvenile idiopathic arthritis. It is characterized by the presence of enthesitis and predominately lower limb arthritis and can affect sacroiliac joint and spine. Recent studies showed that ERA is associated with worse physical status and poorer quality of life (1). The main objective of this study was to compare the aspects of functional status in patients (ERA) and patients with spondyloarthritis (SpA). Methods A retrospective monocentric study was carried out on patients with ERA (ILAR criteria) or SpA (ASAS Criteria). Demographic data and clinical characteristics were obtained from medical records. Disease activity was evaluated by: erythrocyte sedimentation rate (ESR), C-reactive protein rate (CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Functional impairment was evaluated by Bath Ankylosing Spondylitis Functional Index (BASFI) and Ankylosing Spondylitis Quality of life Questionnaire (ASQoL). Global well-being was assessed by Bath Ankylosing Spondylitis Global Index (BASGI). Population was divided into two groups: group 1 (G1) stands for ERA patients and group 2 (G2) stands for SpA patients. P &lt; 0.05 was considered statistically significant. Results A total of 174 patients (40 ERA and 134 SpA) were enrolled. Mean age at disease onset was 12.4 ± 3 years in G1 and 27.8 ± 8 years in G2. Male to female sex ratio was 5.6 in G1 and 3.7 in G2. Morning stiffness (&gt;60 min) was reported by 37.5% of G1 and 49.3%. G1 patients had longer morning stiffness than G2 (61 [0–90] min vs 30 [0–240] min; P = 0.58). Multiple nocturnal awakenings were reported by 45% of G1 patients and 58.2% of G2 patients. Median BASDAI score was 4.9 [1–44] in G1 and 4.5 in G2 [0–10] (P = 0.48). Median BASGI score was 6 [1.5–9.5] in G1 and 6 [0–10] in G2 (P = 0.58). Median ESR was 35 mm/h [8–90] in G1 and 35 mm/h [2–125] in G2. Median CRP was 18.2 mg/l [1–70] in G1 and 13 mg/l [3–180] in G2. The assessment of functional status revealed that G1 patients had higher BASFI scores than G2 patients (5.2 vs 4.5). The association between G1 and BASFI was statistically significant (P = 0.05). Median ASQoL was 12 [2–17] in G1 and 9 [0–18] in G2. No link was noted between G1 and ASQoL score (P = 0.152). Conclusion Our study showed that ERA was associated with higher BASFI scores in comparison with SpA. Treat-to target strategies are mandatory in order to optimize the functional status of children with ERA.

P022 Genetic background predicts the extra-articular involvement in patients with enthesitis related arthritis

Background Enthesitis-related arthritis (ERA) represents 20% of all juvenile idiopathic arthritis subtype. Among the genetic risk factors for the development of ERA, HLA-B27 has been implicated as a major contributor. The frequency of HLA-B27 varies among population. HLA-B 27 status in ERA may influence the clinical phenotype and prognosis of the disease. The main objective of this study is to determine whether genetic background including HLA B27 and familial history of spondylarthritits (SpA) may influence the clinical features of ERA patients. Methods We conducted a retrospective study including patients with ERA, all fulfilling the International League of Associations for Rheumatology (ILAR) criteria. For all patients, we collected the following data: Age, family history of rheumatic inflammatory diseases, inflammatory bowel diseases (IBD), the presence of HLA-B27 antigen, the inflammatory biomarkers: Erythrocyte sedimentation rate (ESR) C-reactive protein (CRP), the disease activity assessed by morning stiffness, night awakenings, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the current treatment. We assessed, as well, the functional impact using the Bath Ankylosing Spondylitis Functional Index (BASFI) the Lequesne index. The population was divided into two groups: a group including patients positive to HLA-B27 antigen and/or with family history of rheumatic inflammatory diseases, psoriasis or inflammatorybowel diseases. The second group was defined as control group with patients negative to HLA-B27 antigen and without any family history of the diseases above. Results We included 40 ERA patients, mean age of onset 12,43 ± 3,003 years (6–16). The majority of them were male (n = 34). Twenty-eight patients had a genetic background. Among them, 7,5% of patients had a positive family history, 42,5% were positive to HLA-B27 antigen and 20% of them met both criteria. As shown in table 1, clinical manifestations were similar between the 2 groups. Enthesitis was more frequent in patients with HLAB27 without a significant difference. Regarding the disease activity, the number of night awakenings and the morning stiffness duration were comparable in the two groups. Six patients had a BASDAI score &gt; 4 with no difference between the two groups. Extra-articular manifestations were present in 15 patients. Among them 14 had a genetic background, reaching the significance threshold with P = 0,013. We counted 8 cases of uveitis, one case of IBD, 5 cases of lung disease and 1 case of cardiac involvement. Inflammatory markers were higher in the group with familial history of SpA and/or positive HLAB27. Indeed, the mean ESR value was 42,73 vs 29.9, P = 0,01. There were no correlations between BASFI score and a positive genetic background (P = 0,283). Only one patient was put on biologics. He has no family history and is negative to HLA-B27 antigen. Conclusion The frequency of HLAB27 was in line with the literature data. The genetic background did not influence the disease activity or the functional impairment in our population. However, a positive correlation was found between a positive familial history of SpA, HLAB27, and the presence of extra-articular manifestations as well as with a higher ESR value.

Effects on health-related quality of life in the randomized, controlled crossover trial ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Background Patients with Rheumatoid Arthritis (RA) often report impaired health-related quality of life (HrQoL) such as difficulties in daily life, pain, fatigue and an affected social life. Even when lowering disease activity, pharmacological treatment does not always resolve these factors. Objective To investigate if a proposed anti-inflammatory diet improves HrQoL in patients with RA. Design In this controlled crossover trial, 50 patients were randomized to start with either an intervention diet (anti-inflammatory) or a control diet (usual Swedish intake) for ten weeks followed by a wash out period before switching to the other diet. Participants received food equivalent to ~1100 kcal/day, five days/week, and instructions to consume similarly for the remaining meals. HrQoL was evaluated using Health Assessment Questionnaire (HAQ), 36-item Short Form Survey (SF-36), Visual Analogue Scales (VAS) for pain, fatigue and morning stiffness, and a time scale for morning stiffness. Results Forty-seven participants completed ≥1 diet period and were included in the main analyses. No significant difference between intervention and control diet at end of diet periods was observed for any outcome. However, significant improvements were obtained for SF-36 Physical Functioning (mean:5.79, SE: 2.12, 95% CI: 1.58, 10.01) during the intervention diet period. When excluding participants with anti-rheumatic medication changes, the differences between diet periods increased for most outcomes, favoring the intervention diet period, and the difference for SF-36 Physical Functioning became significant (n = 25, mean:7.90, 95% CI:0.56, 15.24, p = 0.036). Conclusions In main analyses, the proposed anti-inflammatory diet did not significantly improve HrQoL for patients with RA compared to control diet. In sub-analyses, significant improvements in physical functioning were detected. Larger studies with consistent medication use and in populations more affected by the disease may be needed to obtain conclusive evidence.

Association between pain, anxiety, and alpha2 frontal activity in women with fibromyalgia

Fibromyalgia is a disorder of the central nervous system, with the presence of chronic generalized pain, fatigue, morning stiffness, anxiety and depression symptoms. Higher amplitudes of the frequency band alpha2 have been associated with higher relaxation in this population. In the present study, we analysed the association between pain, anxiety, and the spectral power of alpha2 frontal in women with fibromyalgia. Thirty-one women diagnosed with fibromyalgia, for at least three months, took part in the study. Results revealed a statistically significant positive relationship between pain and anxiety levels. However, we found no association between the spectral power of alpha2 in the frontal cortex and the measures between anxiety and pain in the patients. Present findings emphasize the importance of understanding the cortical activity and the central control mechanisms in fibromyalgia.

Patient-Reported Outcomes of Upadacitinib Versus Abatacept in Patients with Rheumatoid Arthritis and an Inadequate Response to Biologic Disease-Modifying Antirheumatic Drugs: 12-Week Results of a Phase 3 Trial

Background In previous clinical trials, patients with active rheumatoid arthritis (RA) treated with upadacitinib (UPA) have improved patient-reported outcomes (PROs). This post hoc analysis of SELECT-CHOICE, a phase 3, double-blind, randomized clinical trial evaluated the impact of UPA vs abatacept (ABA) with background conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on PROs in patients with RA who have inadequate response or intolerance to biologic DMARDs (bDMARD-IR).Methods: Patients in SELECT-CHOICE received UPA (oral 15 mg once daily) or ABA (intravenous). PROs evaluated included Patient Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), patient’s assessment of pain by VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), duration and severity of morning stiffness, 36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Impairment (WPAI), and EQ-5D 5-Level (EQ-5D-5L) index score. Least squares mean (LSM) changes from baseline to week 12 were based on an analysis of covariance model. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) were compared using chi-square tests.Results: Data from 612 patients were analyzed (UPA, n=303; ABA, n=309). Mean age was 56 years and mean disease duration was 12 years. Thirty-two percent received >1 bDMARD and 72% received concomitant methotrexate at baseline. At week 12, UPA treatment showed significantly greater improvements than ABA treatment in PtGA, pain, HAQ-DI, morning stiffness severity, EQ-5D-5L, WPAI activity impairment domain, and 3/8 SF-36 domains and physical component summary (PCS) scores (P<0.05). Significantly more UPA- vs ABA-treated patients reported improvements ≥ MCID in HAQ-DI (74% vs 64%) and SF-36 PCS (79% vs 66%) and 4/8 domain scores (P<0.05). The proportions of patients achieving MCID in the remaining PROs were similar between groups.Conclusions: In this study, treatment with UPA or ABA resulted in clinically meaningful improvements in PROs at week 12 in patients with active RA. UPA treatment elicited greater improvements in key domains of physical functioning, pain, and general health, and earlier improvements in HAQ-DI compared with ABA.Trial registration: NCT03086343, March 22, 2017

The Neurasthenic Nipper-Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) is a heterogeneous group of paediatric, idiopathic, inflammatory arthritis exceeding >six weeks duration and commonly arising in children beneath <16 years. International League of Associations for Rheumatology (ILAR) has categorized juvenile idiopathic arthritis into distinctive subclasses as pauciarticular variant or oligoarthritis, Rheumatoid Factor (RF) positive polyarthritis, Rheumatoid Factor (RF) negative polyarthritis, systemic arthritis, psoriatic arthritis, enthesitis-related arthritis and undifferentiated arthritis. The condition is posited to arise from environmental factors, viral or bacterial infection or demonstrates a genetic predisposition. Juvenile idiopathic arthritis depicts decimated joint function with reduced Range of Motion (ROM), joint pain, morning stiffness, limping due to pain in the lower extremities, joint deformity and joint swelling commonly discerned within the knee, hand or foot, anomalous limb growth with leg length discrepancies,, uveitis, reoccurring pyrexia, cutaneous rash, myalgia, weight loss and disorders of skeletal growth. An intense, synovial infiltration of T lymphocytes, B lymphocytes, plasma cells, macrophages and dendritic cells is observed along with villous hyperplasia and hypertrophy, endothelial activation and hyperplasia and hyperplasia of synoviocytes.