To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment. Phase III randomised, double-blind, multicentre, multinational, parallel-group study. Patients with active disease despite MTX (12.5-25 mg/week) were randomised to receive 3 mg/kg of CT-P13 (n=302) or INX (n=304) with MTX and folic acid. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 30. Therapeutic equivalence of clinical response according to ACR20 criteria was concluded if the 95% CI for the treatment difference was within ±15%. Secondary endpoints included ACR response criteria, European League Against Rheumatism (EULAR) response criteria, change in Disease Activity Score 28 (DAS28), Medical Outcomes Study Short-Form Health Survey (SF-36), Simplified Disease Activity Index, Clinical Disease Activity Index, as well as pharmacokinetic (PK) and pharmacodynamic (PD) parameters, safety and immunogenicity. At week 30, ACR20 responses were 60.9% for CT-P13 and 58.6% for INX (95% CI -6% to 10%) in the intention-to-treat population. The proportions in CT-P13 and INX groups achieving good or moderate EULAR responses (C reactive protein (CRP)) at week 30 were 85.8% and 87.1%, respectively. Low disease activity or remission according to DAS28-CRP, ACR-EULAR remission rates, ACR50/ACR70 responses and all other PK and PD endpoints were highly similar at week 30. Incidence of drug-related adverse events (35.2% vs 35.9%) and detection of antidrug antibodies (48.4% vs 48.2%) were highly similar for CT-P13 and INX, respectively. CT-P13 demonstrated equivalent efficacy to INX at week 30, with a comparable PK profile and immunogenicity. CT-P13 was well tolerated, with a safety profile comparable with that of INX. CLINICALTRIALS.GOV IDENTIFIER: NCT01217086.

Objective To evaluate the efficacy and safety of the immunotherapeutic vaccine interferon-α kinoid (IFN-K) in a 36-week (W) phase IIb, randomised, double-blind, placebo (PBO)-controlled trial in adults with active systemic lupus erythematosus (SLE) despite standard of care. Methods Patients with SLE (185) with moderate to severe disease activity and positive interferon (IFN) gene signature were randomised to receive IFN-K or PBO intramuscular injections (days 0, 7 and 28 and W12 and W24). Coprimary endpoints at W36 were neutralisation of IFN gene signature and the BILAG-Based Composite Lupus Assessment (BICLA) modified by mandatory corticosteroid (CS) tapering. Results IFN-K induced neutralising anti-IFN-α2b serum antibodies in 91% of treated patients and reduced the IFN gene signature (p<0.0001). Modified BICLA responses at W36 did not statistically differ between IFN-K (41%) and PBO (34%). Trends on Systemic Lupus Erythematosus Responder Index-4, including steroid tapering at W36, favoured the IFN-K and became significant (p<0.05) in analyses restricted to patients who developed neutralising anti-IFN-α2b antibodies. Attainment of lupus low disease activity state (LLDAS) at W36 discriminated the two groups in favour of IFN-K (53% vs 30%, p=0.0022). A significant CS sparing effect of IFN-K was observed from W28 onwards, with a 24% prednisone daily dose reduction at W36 in IFN-K compared with PBO (p=0.0097). The safety profile of IFN-K was acceptable. Conclusions IFN-K induced neutralising anti-IFN-α2b antibodies and significantly reduced the IFN gene signature with an acceptable safety profile. Although the clinical coprimary endpoint was not met, relevant secondary endpoints were achieved in the IFN-K group, including attainment of LLDAS and steroid tapering. Trial registration number NCT02665364.

Background: Patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) are perceived to be more vulnerable to worse COVID-19 infection outcome. Furthermore, severe shortage in hydroxychloroquine supply was experienced. Objective: We presented the psychological responses of Filipino SLE and RA patients to the COVID-19 pandemic and shortage of hydroxychloroquine supply. Methods: A total of 512 completed online surveys from SLE and RA patients were gathered from May 19 to 26, 2020. The online survey collected data on socio-demographics, health status, contact history, health service utilization, use of hydroxychloroquine, COVID-19 knowledge and concerns, precautionary measures, information needs, the validated Impact of Events Scale-Revised (IES-R) and Depression, Anxiety and Stress Scales (DASS-21) ratings. Results: The psychological impact of COVID-19 outbreak was at least moderate in 20%. The mean IES-R score was higher among SLE (22.34, SD=14.39) than RA (18.85, SD=13.24) patients. Stress, anxiety and depression were moderate to severe in 12.3%, 38.7%, and 27.7% of respondents. The mean stress subscale score was 10.11 (SD=7.95), mean anxiety subscale score was 6.79 (SD=6.57) and mean depression subscale score was 9.03 (SD=8.77). The risk factors for adverse mental health during the COVID-19 pandemic include the presence of comorbidity of hypertension and asthma; being a healthcare worker; and presence of specific symptoms of myalgia, cough, breathing difficulty, dizziness and sore throat. The protective factors for mental health during the pandemic include satisfaction with available health information and wearing of face masks. Conclusion: In the third month of the pandemic in the Philippines, 20% of the respondents with lupus and RA experienced moderate to severe psychological impact. There was moderate to severe anxiety in 38.7% and moderate to severe depression in 27%. Identification of factors that affect mental health in lupus and RA is useful in implementation of effective psychological support strategies.

The loss of muscle or fat free mass (FFM) as a result of systemic inflammation and poor nutrition in Chronic Obstructive Pulmonary Disease (COPD), is recognized as an important factor that influences symptoms and disease-related outcomes. To date, there are no data on body composition among Filipino COPD patients and how it impacts COPD disease severity. This paper examined the relationship of Fat Free Mass Index (FFMI = FFM/height) and sarcopenia with COPD disease severity variables. This was a cross-sectional analytic study comparing low and normal FFMI, sarcopenic and nonsarcopenic COPD patients, in terms of lung function, exercise capacity, and quality of life score. Filipino COPD patients older than 40 years were included. Patients performed six minute walking distance (6MWD), handgrip strength (HGS), and quality of life status evaluation using Filipino version of COPD Assessment Test (CAT). Body composition was measured using bioelectrical impedance analysis (BIA). A total of 41 patients were included. The mean age was 69.22 years. The prevalence of being underweight and having sarcopenia was 32% and 46%, respectively. Point biserial correlation showed that COPD patients with low FFMI had a statistically significant reduction in peak inspiratory flow (r= -0.5791, P value 0.0002), peak expiratory flow (r= -0.4475, P value 0.0055), and handgrip strength (r= -0.4560, P value 0.0027); and lower CAT score (r= -0.3422, P value 0.0285). Similar findings were observed among sarcopenic COPD patients. The prevalence of being underweight and having sarcopenia was high. Low FFMI results in reduction of lung function and upper limb muscle strength among Filipino COPD patients.

Disease activity monitoring in SLE includes serial measurement of anti-double stranded-DNA (dsDNA) antibodies, but in patients who are persistently anti-dsDNA positive, the utility of repeated measurement is unclear. We investigated the usefulness of serial anti-dsDNA testing in predicting flare in SLE patients who are persistently anti-dsDNA positive. Data were analysed from patients in a multinational longitudinal cohort with known anti-dsDNA results from 2013 to 2021. Patients were categorized based on their anti-dsDNA results as persistently negative, fluctuating or persistently positive. Cox regression models were used to examine longitudinal associations of anti-dsDNA results with flare. Data from 37 582 visits of 3484 patients were analysed. Of the patients 1029 (29.5%) had persistently positive anti-dsDNA and 1195 (34.3%) had fluctuating results. Anti-dsDNA expressed as a ratio to the normal cut-off was associated with the risk of subsequent flare, including in the persistently positive cohort (adjusted hazard ratio [HR] 1.56; 95% CI: 1.30, 1.87; P < 0.001) and fluctuating cohort (adjusted HR 1.46; 95% CI: 1.28, 1.66), both for a ratio >3. Both increases and decreases in anti-dsDNA more than 2-fold compared with the previous visit were associated with increased risk of flare in the fluctuating cohort (adjusted HR 1.33; 95% CI: 1.08, 1.65; P = 0.008) and the persistently positive cohort (adjusted HR 1.36; 95% CI: 1.08, 1.71; P = 0.009). Absolute value and change in anti-dsDNA titres predict flares, including in persistently anti-dsDNA positive patients. This indicates that repeat monitoring of dsDNA has value in routine testing.