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Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period
ObjectiveTanezumab, a nerve growth factor inhibitor, was investigated for osteoarthritis (OA) of the hip or knee in a study with 24-week treatment and 24-week safety follow-up.MethodsThis double-blind, randomised, phase III study enrolled adults in Europe and Japan with moderate-to-severe OA who had not responded to or could not tolerate standard-of-care analgesics. Patients were randomised to tanezumab 2.5 mg or 5 mg subcutaneously or matching placebo every 8 weeks (three doses). Co-primary end points were change from baseline to week 24 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Physical Function, and Patient’s Global Assessment of OA (PGA-OA). Joint safety and neurological assessments continued throughout the 48-week study.ResultsFrom March 2016 to December 2017, 849 patients were randomised and evaluated (placebo n=282, tanezumab 2.5 mg n=283, tanezumab 5 mg n=284). At week 24, there was a statistically significant improvement from baseline for tanezumab 5 mg compared with placebo for WOMAC Pain (least squares mean difference±SE –0.62±0.18, p=0.0006), WOMAC Physical Function (–0.71±0.17, p<0.0001) and PGA-OA (–0.19±0.07, p=0.0051). For tanezumab 2.5 mg, there was a statistically significant improvement in WOMAC Pain and Physical Function, but not PGA-OA. Rapidly progressive osteoarthritis (RPOA) was observed in 1.4% (4/283) and 2.8% (8/284) of patients in the tanezumab 2.5 mg and tanezumab 5 mg groups, respectively and none receiving placebo. Total joint replacements (TJRs) were similarly distributed across all three treatment groups (6.7%–7.8%). Tanezumab-treated patients experienced more paraesthesia (5 mg) and hypoaesthesia (both doses) than placebo.ConclusionTanezumab 5 mg statistically significantly improved pain, physical function and PGA-OA, but tanezumab 2.5 mg only achieved two co-primary end points. RPOA occurred more frequently with tanezumab 5 mg than tanezumab 2.5 mg. TJRs were similarly distributed across all three groups.Trial registration numberNCT02709486.
Journal Article
Effect of a Mediterranean type diet on inflammatory and cartilage degradation biomarkers in patients with osteoarthritis
To investigate the effects of a Mediterranean type diet on patients with osteoarthritis (OA).
Ninety-nine volunteers with OA (aged 31 - 90 years) completed the study (83% female).
Southeast of England, UK.
Participants were randomly allocated to the dietary intervention (DIET, n = 50) or control (CON, n = 49). The DIET group were asked to follow a Mediterranean type diet for 16 weeks whereas the CON group were asked to follow their normal diet.
All participants completed an Arthritis Impact Measurement Scale (AIMS2) pre-, mid- and post- study period. A subset of participants attended a clinic at the start and end of the study for assessment of joint range of motion, ROM (DIET = 33, CON = 28), and to provide blood samples (DIET = 29, CON = 25) for biomarker analysis (including serum cartilage oligomeric matrix protein (sCOMP) (a marker of cartilage degradation) and a panel of other relevant biomarkers including pro- and anti-inflammatory cytokines).
There were no differences between groups in the response of any AIMS2 components and most biomarkers (p > 0.05), except the pro-inflammatory cytokine IL-1α, which decreased in the DIET group (~47%, p = 0.010). sCOMP decreased in the DIET group by 1 U/L (~8%, p = 0.014). There was a significant improvement in knee flexion and hip rotation ROM in the DIET group (p < 0.05).
The average reduction in sCOMP in the DIET group (1 U/L) represents a meaningful change, but the longer term effects require further study.
Journal Article
Effect of Lifestyle Counselling via a Mobile Application on Disease Activity Control in Inflammatory Arthritis: A Single-Blinded, Randomized Controlled Study
Mobile applications (apps) are a resource for information on lifestyle and nutrition which are associated to improved outcomes in inflammatory arthritis.
The aim of this study was to explore whether targeted lifestyle counselling via an app improves disease activity in arthritis patients.
Patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA) were randomized to 12 weeks of lifestyle counselling via an app (Mida, Midaia GmbH, Germany) pertaining to a healthy Mediterranean Diet, physical activity, and mental health. Disease activity was measured with specific instruments by a blinded physician and categorized (remission, low, moderate, high). Dietary adherence was assessed by the Mediterranean Diet Adherence Screener (MEDAS). Mixed effects logistic regression adjusted to baseline disease activity, age, and sex were calculated.
Of 158 patients included (73% female, 53.3 ± 11.7 years), 74 were in the active counselling group (ACG). All showed improvement in low disease activity or remission. ACG patients had an odds ratio (OR) of 2.8 (95%-CI 1.1-7.2,
= 0.035), while OR in the control group was not significant OR = 2.1 (0.9-5.0,
= 0.097). The control group was less likely to reach a MEDAS >= 4 (OR = 0.16 (0.03-0.77),
= 0.02), while this was not seen in the ACG (OR = 0.54 (0.06-4.63),
= 0.6). Patients in the ACG showed a tendency towards improved adhesion to a Mediterranean Diet (MEDAS) (β = 0.35 (-0.05-0.74),
= 0.086). This tendency was not observed in the control group (β = 0.09 (-0.29-0.46),
= 0.64).
Individualized lifestyle and dietary counselling via app may help to improve disease control in inflammatory arthritis patients.
Journal Article
Effects of self-monitoring physical activity with wearable activity trackers on perceived joint function and health-related quality of life in people with hip and knee osteoarthritis: a secondary analysis of a cluster-randomised clinical trial
Background
Osteoarthritis (OA) often leads to pain and functional limitations, impacting work and daily life. Physical activity (PA) is an important part of the treatment. Wearable activity trackers (WATs) offer a novel approach to promote PA but could also aid in finding a sustainable PA level over time. The aim of this secondary analysis was to examine the effects of self-monitoring PA with a WAT on perceived joint function and health-related quality of life in people with hip and knee OA.
Method
A two-armed cluster-randomized controlled trial (C-RCT) was conducted in southern Sweden including 160 individuals with hip or knee OA. The participants were cluster-randomized to a Supported Osteoarthritis Self-management Program (SOASP) with the addition of self-monitoring PA using a commercial WAT for 12 weeks (n = 86), or only the SOASP (
n
= 74). The outcomes include perceived joint function measured with HOOS/KOOS and health-related quality of Life (HRQoL) measured with EQ-5D-3L index and EQ VAS. Participants responded to the questionnaires at baseline and at follow-up after 3, 6 and 12 months. Statistical analyses involved linear mixed models, ANCOVA and paired t-test.
Results
Participants with data from baseline and at least one follow-up were included in the analyses (
n
= 124). The analyses showed no statistically significant differences in changes between the groups in perceived joint function or HRQoL throughout the study period. Both groups improved in pain and symptoms, but the changes were small.
Conclusion
The addition of WAT-use did not have any effect on perceived joint function or HRQoL. The participants’ relatively high baseline scores might have influenced the outcomes of this study. We suggest that future WAT-interventions target inactive people with OA and use devices that also captures other activities such as cycling or aquatic exercise.
Trial registration
ClinicalTrials.gov, NCT03354091. Registered 15/11/2017.
Journal Article
Pain-free joints : 46 simple qigong movements for arthritis healing and prevention
\"Highlights the exercides you need to treat your arthritis. The gentle, meditative movements emphasize proper motion in coordination with breath. By committing to a simple qigong practice, you can begin to take care of your own joints, to prevent and heal injuries and maintain loose, flexible, and healthy joints.\"--Provided by publisher.
Book
MicroRNA-155 as a proinflammatory regulator in clinical and experimental arthritis
MicroRNA (miRNA) species (miR) regulate mRNA translation and are implicated as mediators of disease pathology via coordinated regulation of molecular effector pathways. Unraveling miR disease-related activities will facilitate future therapeutic interventions. miR-155 recently has been identified with critical immune regulatory functions. Although detected in articular tissues, the functional role of miR-155 in inflammatory arthritis has not been defined. We report here that miR-155 is up-regulated in synovial membrane and synovial fluid (SF) macrophages from patients with rheumatoid arthritis (RA). The increased expression of miR-155 in SF CD14⺠cells was associated with lower expression of the miR-155 target, Src homology 2-containing inositol phosphatase-1 (SHIP-1), an inhibitor of inflammation. Similarly, SHIP-1 expression was decreased in CD68⺠cells in the synovial lining layer in RA patients as compared with osteoarthritis patients. Overexpression of miR-155 in PB CD14⺠cells led to down-regulation of SHIP-1 and an increase in the production of proinflammatory cytokines. Conversely, inhibition of miR-155 in RA synovial CD14⺠cells reduced TNF-α production. Finally, miR-155-deficient mice are resistant to collagen-induced arthritis, with profound suppression of antigen-specific Th17 cell and autoantibody responses and markedly reduced articular inflammation. Our data therefore identify a role of miR-155 in clinical and experimental arthritis and suggest that miR-155 may be an intriguing therapeutic target.
Journal Article