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Objectives To investigate efficacy and safety of the Janus kinase-1 inhibitor filgotinib in patients with active rheumatoid arthritis (RA) with limited or no prior methotrexate (MTX) exposure. Methods This 52-week, phase 3, multicentre, double-blind clinical trial (NCT02886728) evaluated once-daily oral filgotinib in 1252 patients with RA randomised 2:1:1:2 to filgotinib 200 mg with MTX (FIL200 +MTX), filgotinib 100 mg with MTX (FIL100 +MTX), filgotinib 200 mg monotherapy (FIL200), or MTX. The primary endpoint was proportion achieving 20% improvement in American College of Rheumatology criteria (ACR20) at week 24. Results The primary endpoint was achieved by 81% of patients receiving FIL200+ MTX versus 71% receiving MTX (p Conclusions FIL200+MTX and FIL100+MTX both significantly improved signs and symptoms and physical function in patients with active RA and limited or no prior MTX exposure; FIL200 monotherapy did not have a superior ACR20 response rate versus MTX. Filgotinib was well tolerated, with acceptable safety compared with MTX.

Objectives Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We characterized tofacitinib efficacy/safety in Indian vs rest of the world (ROW; excluding India) RA patients. Methods Efficacy data were pooled for disease‐modified antirheumatic drug (DMARD) inadequate responders from Phase (P)3 studies. For Indian patients, ORAL Solo and ORAL Scan; ROW (excluding India), these studies plus ORAL Step, ORAL Sync, and ORAL Standard. Safety data also included ORAL Start (P3; methotrexate‐naïve) and ORAL Sequel (long‐term extension [LTE] study; data cut‐off March 2017) for Indian patients, and these studies plus A3921041 (LTE study; Japanese study) for ROW. Efficacy outcomes at months 3/6: American College of Rheumatology (ACR)20/50/70; Disease Activity Score in 28 joints, erythrocyte sedimentation rate remission/low disease activity; change from baseline in Health Assessment Questionnaire‐Disability Index. Incidence rates (IRs; patients with events/100 patient‐years) for adverse events of special interest (AESIs) were assessed throughout. Descriptive data underwent no formal comparison. Results One‐hundred‐and‐ninety‐seven Indian and 3879 ROW patients were included. Compared with ROW patients, Indian patients were younger, had lower body mass index, shorter RA duration, and higher baseline disease activity; most Indian patients were non‐smokers and all were biologic DMARD (bDMARD)‐naïve. Month 3 ACR20 rates with tofacitinib 5 mg twice daily/10 mg twice daily/placebo were 67.4%/82.1%/40.9% (India) and 59.0%/66.1%/28.2% (ROW), and month 6 rates were 76.2%/92.1%/88.9% (India) and 69.0%/74.2%/66.5% (ROW). Month 3/6 improvements in other outcomes were generally numerically greater with tofacitinib vs placebo, and similar in both populations. Compared with ROW, Indian patients had numerically fewer AEs/serious AEs, and similar IRs for discontinuations due to AEs and AESIs, except that tuberculosis (TB) IR was higher in Indian (IR = 1.21; 95% CI 0.49, 2.49) vs ROW patients (IR = 0.17; 95% CI 0.11, 0.25). Conclusions Tofacitinib efficacy/safety were similar in both populations, except TB IR, which was higher in Indian patients but in line with those in bDMARD‐treated RA patients from high‐risk countries (IR = 0.00‐2.56; TB IR >0.05 [World Health Organization]). Limitations included the small Indian population and baseline differences between populations.

Objectives To study the efficacy and safety of Withania somnifera (WS) in the prophylaxis against COVID-19 in high risk health care workers (HCW) in comparison to hydroxychloroquine (HCQ). To evaluate general physical and mental health benefits of Ashwagandha. Methods A 16 week randomized prospective, open label, parallel efficacy, two arm multi-centre study. The primary efficacy measure is ‘failure of prophylaxis’ as confirmed COVID-19 by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) at any time during the study period. This study on 400 participants from three centres is designed to establish non-inferiority for WS to HCQ for prophylaxis against COVID-19 at 80% power and significance P

Objectives: Comparative study of Ashwagandha (Withania somnifera; WS) and hydroxychloroquine (HCQ) for chemoprophylaxis against COVID-19 in actively engaged high-risk health-care workers. Design: Randomized, multicentric, open label, active control, two arm parallel efficacy study of 16 weeks. Sample size was based on pre-set 15% non-inferiority margin to HCQ for prophylaxis against COVID-19 with 80% power and alpha < 0.05. Participants: 400 health-care workers from three sites who were asymptomatic and tested negative for a quantitative Reverse Transcription Polymerase Chain Reaction test (RT-PCR) for COVID-19 and SARS-CoV-2 antibodies (IgG) were randomized in a 1:1 ratio. Participants observed physical protection measures as per the national policy. All incident confirmed COVID-19 were withdrawn.Interventions: Two tablets of 250 mg standardized aqueous extract of WS, twice daily after meal or HCQ 800 mg loading followed by 400 mg weekly for 16 weeks as per the national guidelines. Main outcome measures: The primary efficacy measure was “failure of prophylaxis” as confirmed by RT-PCR at any time during the study. Both intention-to-treat (ITT) and per-protocol (PP) efficacy analyses were performed.Results: 95 participants in the Ashwagandha (WS) arm and 101 participants in the HCQ arm completed the study. Both groups were well matched at the baseline. 91 participants from the Ashwagandha arm and 84 from the HCQ arm were withdrawn because they received the COVID-19 vaccination. Four participants (2%; 95% CI 2.8 to 3.9%) in the Ashwagandha and 5 (2.5%; 95% CI 5.4 to 8%) in the HCQ arm developed confirmed COVID-19. This was within the prefixed non-inferiority margin and the 95% CI of the absolute risk reduction (ARR) was -2.9 to 3.8% intention to treat (ITT) and -5.9 to 7.5% per protocol (PP). The 95% CI of ARR for the total COVID-19 cases was -2.8 to 11.9% ITT and -5.7 to 20.3% PP. Several health measures, particularly anxiety and stress, improved significantly in the Ashwagandha arm. Seven out of 117 in the Ashwagandha and 59 out of 178 in the HCQ groups were reported to be possible drug-related adverse events (AE); there were significantly less gut-related AE in the Ashwagandha group. AE were mostly mild and did not cause withdrawal. All incident COVID-19 cases recovered without complications. Conclusions: Ashwagandha was non-inferior to HCQ in the chemoprophylaxis against COVID-19 in high risk health-care workers. It was significantly safer, well tolerated and improved quality of life measures. Ashwagandha as COVID-19 prophylaxis seems appropriate in high-risk populations. Trial registration: The Clinical Trials Registry India Number CTRI/2020/08/027163 dated August 14, 2020.

Objective.To compare the association between different remission criteria and physical function in patients with rheumatoid arthritis followed in clinical practice.Methods.Longitudinal data from the METEOR database were used. Seventeen definitions of remission were tested: American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based; Simplified/Clinical Disease Activity Index (SDAI/CDAI); and 14 Disease Activity Score (DAS)-based definitions. Health Assessment Questionnaire (HAQ) ≤ 0.5 was defined as good functional status. Associations were investigated using generalized estimating equations. Potential confounders were tested and sensitivity analyses performed.Results.Data from 32,915 patients (157,899 visits) were available. The most stringent definition of remission was the ACR/EULAR Boolean-based definition (1.9%). The proportion of patients with HAQ ≤ 0.5 was higher for the most stringent definitions, although it never reached 100%. However, this also meant that, for the most stringent criteria, many patients in nonremission had HAQ ≤ 0.5. All remission definitions were associated with better function, with the strongest degree of association observed for the SDAI (adjusted OR 3.36, 95% CI 3.01–3.74).Conclusion.The 17 definitions of remission confirmed their validity against physical function in a large international clinical practice setting. Achievement of remission according to any of the indices may be more important than the use of a specific index. A multidimensional approach, targeted at wider goals than disease control, is necessary to help all patients achieve the best possible functional status.

IntroductionThe government of India has rolled out COVID-19 vaccine program for individuals who are 18 years of age and above and priority is being given to the elderly, and individuals with morbidity. Oxford-AstraZeneca COVID-19 vaccine (COVISHIELD™) is most widely used in India. A large number of Indian people have been consuming various traditional medicines in the hope of better protection against COVID-19 infection. Several studies have reported immunological benefits of Ashwagandha and its potential as vaccine adjuvant. We plan to study co-administration of Ashwagandha with COVISHIELD™ vaccine on safety, immunogenicity and protection.Methods and analysisWe designed a prospective, randomized, double blind, parallel group, placebo controlled, two arm, exploratory study on healthy volunteers receiving the COVISHIELD™ vaccine. In addition to the two dose schedule of COVISHIELD vaccine as per national guidelines, participants will be administered 8gm Ashwagandha or placebo tablets respectively per day. Primary outcome measure is immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titres. Secondary outcome measures are safety, protective immune response and quality of life measures. Adverse event following immunization will be monitored at each time throughout the study. Participants will be tracked on a daily basis with a user friendly mobile phone application. Following power calculation 600 participants will be recruited per arm to demonstrate superiority by a margin of 7% with 80% power. Study duration is 28 weeks with interim analysis at the end of 12 weeks.Ethics and disseminationEthical approval was obtained through the Central and institutional Ethics Committees. Participant recruitment is expected to commence by August 2021. Results will be presented in conferences and published in preprint followed by peer-reviewed medical journals.Registration detailsClinical Trial Registry – India (CTRI) Registration Number: CTRI/2021/06/034496. Date of Registration June 30, 2021.Strengths and limitations of this studyNovel study to demonstrate effect of coadministration of immune adjuvant and COVID-19 vaccine on safety and immunogenicity.Randomised placebo controlled 28 weeks study with 80 percent power to demonstrate role of putative natural immunomodulator to augment the protection and reduce breakthrough infectionsState of art immune assays to measure specific antibodies to SARS-CoV-2 to demonstrate both persistent and late upsurge in immune responseDaily tracking of participants using a study specific designed mobile appAn interim analysis is planned to provide information on early immune response after first dose of vaccineParticipants may be reluctant to donate blood repeatedly for immune assays; compliance with the test drug may be a challenge; asymptomatic infections may be missed; the study is not measuring cellular immune response.

ObjectivesTo compare the co-administration of an Ayurvedic drug AYUSH 64 as an adjunct to standard of care (SOC) and SOC for efficacy and safety in the management of COVID-19.DesignMulticentre, parallel efficacy, randomized, controlled, open label, assessor blind, exploratory trial with a convenience sample. Patients followed to complete 12 weeks of study duration.SettingCOVID-19 dedicated non-intensive care wards at 1 government hospital, 1 medical college teaching hospital and 1 medical university teaching hospitalParticipants140 consenting, eligible, hospitalized adult patients suffering from mild and moderate symptomatic COVID-19 and confirmed by a diagnostic (SARS-CoV-2) RT-PCR assay on nasal and throat swab were randomized to SOC or SOC plus AYUSH 64. To be withdrawn if disease becomes severe.InterventionsTwo tablets of AYUSH 64, 500 mg each, twice daily after meals, and continued till study completion. SOC (symptomatic and supportive) as per national guidelines of India for mild and moderate disease.Main outcome measuresTime period to clinical recovery (CR) from randomization baseline and proportion with CR within 28 days time frame; CR defined in the protocolResults140 patients randomized (70 in each arm); 138 patients with CR qualified for analysis. Both groups were matched at baseline. The mean time to CR from randomization was significantly superior in AYUSH 64 group (95% CI -3.03 to 0.59 days); a higher proportion (69.7%) in the first week (p=0.046, Chi-square). No significant differences observed for COVID-19 related blood assays (such as D-Dimer). AYUSH 64 arm showed significant (pConclusionsAYUSH 64 hastened recovery, reduced hospitalization and improved overall health in mild and moderate COVID-19 when co-administered with SOC under medical supervision. It was safe and well tolerated. Further studies are warranted.Trial registrationThe Clinical Trials Registry India Number CTRI/2020/06/025557FundingCCRAS, Ministry of AYUSH, Government of India

Finding appropriate pharmacological options to treat osteoarthritis (OA) remain challenging. We aimed to determine the efficacy and safety of all types of turmeric extracts for the management of knee OA. Sixteen RCTs of up to 16 weeks duration including 1810 adults with knee OA were included. Eleven RCTs compared the efficacy of turmeric extracts with placebo and five with active comparators (NSAIDs). The overall risk bias of included RCTs was moderate. Turmeric extracts significantly reduced knee pain (SMD − 0.82, 95% CI − 1.17 to − 0.47, I2 = 86.23%) and improved physical function (SMD − 0.75, 95% CI − 1.18 to − 0.33, I2 = 90.05%) compared to placebo but had similar effects compared to NSAIDs. BMI was the major contributor to heterogeneity in the placebo-controlled studies (explained 37.68% and 67.24%, respectively, in the models) and modified the effects of the turmeric on pain and physical function with less improvement with higher BMI (SMD 0.26 95% CI 0.04 to 0.48; SMD 0.48 95% CI 0.21 to 0.74). No significant between-group differences were reported for either biochemical markers or imaging outcomes. Turmeric extracts had 12% fewer adverse events than NSAIDs and similar rates to placebo. Turmeric extract is a safe and effective option for the symptomatic management of knee OA, compared to placebo or NSAIDs. However, current evidence from short-term studies is heterogeneous and has moderate risk of bias leading to some uncertainty about the true effect.

Background: Much research has been done on reproductive tract infections (RTIs), but no study exists about RTIs among rheumatoid arthritis women. Objectives: This study investigated the prevalence and risk factors of RTIs among reproductive-aged women with rheumatoid arthritis in Pune, India. Methods: This clinical-based, cross-sectional study enrolled a sample of 400 consenting Indian women aged 15 -49 years with a history of at least three months’ rheumatoid arthritis referring to a popular community center. Patients were interviewed comprehensively using previously validated relevant questionnaires. Women underwent gynecological examinations and vaginal smears (wet mount) by a microbiologist to diagnose candidiasis, bacterial vaginosis, and trichomoniasis. Syphilis serological testing was performed for the study population. Results: The prevalence obtained was 39.3%. Infection with bacterial vaginosis was 32.0%, Candidiasis 6.5%, and trichomoniasis 0.8%. Syphilis seroconversion was not observed. Adjusting for confounding factors in logistic regression showed that four factors remained significant, including age under 30 years [AOR: 2.4, 95% CI: 1.2 - 4.9], living in a crowded and small one-room house [AOR: 2.5, 95% CI: 1.2 - 5.1] , improper linen for menstruation bleeding [AOR: 1.9, 95% CI: 1.1 - 3.3], and oral disease-modifying anti-rheumatic drugs [AOR: 3.96, 95% CI: 1.9 - 7.9]. Conclusions: This study demonstrated a large burden of RTIs in women suffering from rheumatoid arthritis. Regular screening algorithms for RTIs are urgently required to prevent neglect and improve overall standard care in rheumatology practice. The presence of an oral disease-modifying anti-rheumatic drug as a risk factor shows that more investigation is necessary in this case.

Objective To identify possible differences in baseline characteristics, initial treatment and treatment response between RA patient subgroups based on age at disease onset. Methods Daily practice data from the worldwide METEOR registry were used. Patients (7912) were stratified into three age-groups (age at disease diagnosis 65 years). Initial treatment was compared between the different age-groups. With Cox regression analyses the effect of age-group on time-to-switch from first to second treatment was investigated, and with linear mixed models differences in response to treatment (DAS and HAQ) between the age-groups were assessed, after correction for potential confounders. Results The >65 years age-group included more men, and more seronegative RA with somewhat higher inflammatory markers. Initial treatment choices differed only slightly between the age-groups, and the time-to-switch from initial treatment to the next was similar. DAS and HAQ improvement were dependent on the age-group, reflected by a significant interaction between age-group and outcome. The stratified analysis showed a difference of −0.02 and −0.05 DAS points and, −0.01 and 0.02 HAQ points per month in the 65 year age group, a difference that did not seem clinically relevant. Conclusion In this international study on worldwide clinical practice, patients with RA onset >65 years include more men and seronegative arthritis, and were initially treated slightly differently than younger patients. We observed no clinically relevant differences in timing of a next treatment step, or response to treatment measured by DAS and HAQ.

Objective.To assess differences in initial treatment and treatment response in male and female patients with rheumatoid arthritis (RA) in daily clinical practice.Methods.The proportion of patients with RA starting different antirheumatic treatments (disease-modifying antirheumatic drugs; DMARD) and the response to treatment were compared in the international, observational METEOR register. All visits from start of the first DMARD until the first DMARD switch or the end of followup were selected. The effect of sex on time to switch from first to second treatment was calculated using Cox regression. Linear mixed model analyses were performed to assess whether men and women responded differently to treatments, as measured by Disease Activity Score (DAS) or Health Assessment Questionnaire.Results.Women (n = 4393) more often started treatment with hydroxychloroquine, as monotherapy or in combination with methotrexate (MTX) or a glucocorticoid, and men (n = 1142) more often started treatment with MTX and/or sulfasalazine. Time to switch DMARD was shorter for women than for men. Women had a statistically significantly higher DAS over time than men (DAS improvement per year β −0.69, 95% CI −0.75 to −0.62 for men and −0.58, 95% CI −0.62 to −0.55 for women). Subanalyses per DMARD group showed for the conventional synthetic DMARD combination therapy a slightly greater decrease in DAS over time in men (−0.89, 95% CI −1.07 to −0.71) compared to women (−0.59, 95% CI −0.67 to −0.51), but these difference between the sexes were clinically negligible.Conclusion.This worldwide observational study suggests that in daily practice, men and women with RA are prescribed different initial treatments, but there were no differences in response to treatment between the sexes.

Rheumatoid arthritis is a painful inflammatory disorder. Patients seek relief mostly with analgesics and anti-inflammatory drugs which are rife with life-threatening side effects. Alterations in the body’s potassium (K) status may be one such factor. K along with sodium is critical to cellular homeostasis and the electrophysiology of nerve impulses. This review is based on the premise that K can be used therapeutically to reduce joint pain and inflammation in RA and co-morbidity. K ion channel inhibition was shown to cause persistent nerve stimulation (a prelude to pain sensation) and altered immunity (T cells) in experimental studies. Diets rich in K (with normal/reduced salt intake) have to reduce hypertension in several large population studies. Premature atherosclerosis-related cardiovascular disorders and osteoporosis are important complications of RA. The third National Health and Nutrition Examination Survey (1994) carried out in the USA also reported hypokalemia in several RA patients. A diet deficient in K in RA patients was recently reported by an Indian study. In a controlled clinical trial (Iran), K supplementation (diet-based) led to a significant reduction in pain and arthritis in women suffering from seropositive RA. Some of the benefits of K in RA were postulated to be due to an improved cortisol status. K is not a known therapeutic agent in the treatment of RA. Vegetables and fruits are rich sources of K and provide a safe option for intervention. The existing data on the potential therapeutic role of K in RA is encouraging and merits further research.

ObjectiveTo investigate associations between baseline presence of erosions and/or anti-citrullinated protein antibodies (ACPA) on functional ability, disease activity and treatment survival over time.MethodsReal life data from newly diagnosed rheumatoid arthritis patients were identified in the international METEOR registry. Patients were grouped according to presence/absence of ACPA and/or erosions at baseline. Associations between the presence of ACPA and/or erosions (four groups) with the change of Disease Activity Score (DAS) and Health Assessment Questionnaire (HAQ) over time were assessed using linear mixed models during maximum 6 or maximum 12 months from baseline. Treatment survival was assessed using multiple failure-times Cox regression.ResultsData were included from 701 ACPA‒/erosions‒, 334 ACPA‒/erosions+, 1585 ACPA+/erosions‒ and 1993 ACPA+/erosions+ patients. We found statistically significant differences in DAS and HAQ change over time between the four groups, both after maximum follow-up durations of 6 and of 12 months, but after stratification differences proved small and not clinically meaningful. Patients in the ACPA‒/erosions‒ group were less likely to switch treatment compared with the ACPA+/erosions‒ reference group (pConclusionsIn this analysis of worldwide real life data, we found statistically significant, but clinically irrelevant differences in treatment response to initial disease modifying anti-rheumatic drug therapies as measured by DAS and HAQ in ACPA‒/erosions‒, ACPA‒/erosions+, ACPA+/erosions‒ and ACPA+/erosions+ rheumatoid arthritis patients. However, after maximum follow-up durations of 6 and 12 months all groups had a similar response to initial treatment, but with a lower likelihood to switch treatment for ACPA‒/erosions‒ patients during the first year of follow-up.

Background Despite efforts to predict treatment response, treatment of rheumatoid arthritis (RA) patients remains mostly a case of trial and error. Presence of erosions and ACPA are often considered poor prognostic factors based on their association with radiographic damage progression, but with the introduction of treat-to-target ever fewer patients develop significant radiographic damage. Therefore research into prognostic factors should focus on clinical outcomes. Objectives To investigate in newly diagnosed RA patients if presence of erosions and/or ACPA are associated with functional ability, disease activity and treatment survival during the first year of treatment in daily practice. Methods Newly diagnosed patients with a clinical diagnosis of RA, ≥3 months follow-up and available data on ACPA, erosions and medication were identified in the international, observational METEOR registry (n patients=4623). Timing and frequency of follow-up visits were according to daily practice. We focused at results after a maximum follow-up duration of 6 months or of 1 year from baseline. Associations between the presence of erosions and/or ACPA (4 groups) with the change of DAS and HAQ over time were assessed using linear mixed models. Time to treatment change during the first year of follow-up was compared between the ACPA/erosions groups using multiple failure-times Cox regression. Treatment change was defined as a change in type of treatment. A change in medication dose or tapering was not considered a treatment change. Missing data were imputed using multiple chained equations (40 cycles) and models were adjusted for the potential confounders age, gender, smoking, symptom duration, BMI, initial medication and country. In case of statistically significant effect modification (p 5 years), results were stratified. Results Baseline characteristics and follow-up duration of each ACPA/erosions group are shown in table 1. Baseline DAS and HAQ were slightly higher in erosions+ patients. Follow-up duration was similar between the 4 groups. We found statistically significant differences in DAS and HAQ change over time between the 4 groups, both after maximum follow-up durations of 6 months and of 1 year (table 1), but differences were small and not clinically relevant. Patients who were erosions-/ACPA- were less likely to switch treatment [HR (95% CI) 0.79 (0.69; 0.90)] compared to a reference group of erosions-/ACPA+ patients. Patients who were erosions+/ACPA- [HR (95% CI) 0.92 (0.79; 1.08)] or erosions+/ACPA+ [HR (95% CI) 1.01 (0.92; 1.10)] were not statistically significantly different from the reference group in their likelihood to switch treatment. No effect modification was found by country, medication or symptom duration. Conclusion In this analysis of worldwide real life data, we found statistically significant, but no clinically relevant differences in treatment response to initial DMARD therapies as measured by DAS and HAQ in ACPA-/erosions-, ACPA-/erosions+, ACPA+/erosions- and ACPA+/erosions+ RA patients. However, ACPA-/erosions- patients were less likely to switch treatment. Thus, in newly diagnosed RA patients who are treated according to modern treatment strategies, the (combined presence of) ACPA and erosions was no risk factor for worse disease activity or physical functioning, although ACPA-/erosions- patients had fewer treatment changes. Disclosure of Interests Sytske Anne Bergstra Grant/research support from: Bristol-Myers Squibb provided funding for the completion of this study and the development of the abstract., Maura Couto: None declared, Nimmisha Govind: None declared, Arvind Chopra Grant/research support from: Pfizer Inc, Karen Solomon-Escoto: None declared, Elizabeth Murphy Consultant for: Has received support from Roche to audit work on behalf of the Scottish Society for Rheumatology., Thomas Huizinga Consultant for: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, GSK, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience Inc., Nycomed, Boeringher, Takeda, Zydus, Epirus, Eli Lilly, Cornelia Allaart: None declared

Background:Clinical profile of myositis differs in respect of the setting. We present a single center experience from a community based referral centerObjectives:STUDY CLINICAL PROFILE OF INFLAMMATORY MYOSITIS (IM)Methods:We present data from 114 patients of connective tissue disorders (CTD) with dominant Inflammatory Myopathy(IM) evaluated in CRD where we have patient database since 1996. Standard investigations & ELISA, immunoblot and nephlometry to assay autoantibodies (AAb) were done. Data extraction done from 2005-2017Results:36 and 28 patients respectively diagnosed as dominant idiopathic dematomyositis (DM) and polymyositis (PM); remaining 41 patients showed overlap (OCTD). Mean onset age range 33-40 years in each subset with women dominance. Exclusive proximal muscle involvement seen 64% DM, 67% PM and 43% OCTD. 12 of OCTD showed classical DM rash. Raynauds’s phenomenon was seen in 38% (25% DM, 10% PM, 65% OCTD). 83% OCTD showed inflammatory polyarthritis; DM 29% and PM 42%. Two patients DM also diagnosed malignancy (ovarian CA). 25% DM, nil PM and 31.7% OCTD showed CT based lung findings. Mean creatinine phosphokinase at diagnosis were DM 1580, PM 2239 & OCTD 830. EMG required in 48 patients confirmed diagnosis (DM 17, PM 16 and OCTD 15). Seven patients with diagnostic dilemma/ poor therapy response required muscle histopathology confirmation. 59% DM,69% PM and 84% OCTD were seropositive ANA positive in 71%(ENA profile available for most). All Patients received steroids. Methotrexate prescribed in (92%), Azthioprine in (28%), hydroxychloroquine in (88%) with majority showing good response. Mycophenolate prescribed in (6%) for aggressive disease, IVIG in 2 patients for acute IIM with interstitial pneumonitis. Rituximab was prescribed in 4 resistant cases; all responding favourably. Mortality data of 4 patients(severe myositis(1), interstitial pneumonitis(1), ovarian cancer(1), septic shock(1)) was available. Antesynthatase syndrome noted in 9 patients.Conclusion:Overlap CTD with myositis seems more common profile than DM or PM. Response to therapy was satisfactory with steroids and methotrexate being the mainstay. Rituximab is a promising biological agent in chronic resistant cases.References:[1]A Kumar. Idiopathic Inflammatory Myopathies. Suppliment to JAPI, JUNE 2006, VOL. 54; Pg 62-66[2]R Porkodi et al Clinical Spectrum of Inflammatory Myositis in South India - A Ten Year Study. J Assoc Physicians India 2002;50:1255-1258[3]Chowdhary V, Aggarwal A, Misra R. Prevalence and clinical association of myositis-specific autoantibodies in North Indian patients with idiopathic inflammatory myopathy. APLAR J Rheumatol 2 001.Acknowledgments :STAFF AND PATIENTS OF CENTER FOR RHEUMATIC DISEASES, PUNEDisclosure of Interests: :NACHIKET KULKARNI Speakers bureau: PFIZER, NOVARTIS, YANSEN, Anuradha Venugopalan: None declared, MANJIT SALUJA: None declared, Arvind Chopra Grant/research support from: Zydus Pharamceutical Ltd India

Background:Filgotinib (FIL) is a potent, selective JAK 1 inhibitor. FINCH 3 assessed FIL efficacy and safety in methotrexate (MTX)-naïve patients (pts) with rheumatoid arthritis (RA); week (W)24 primary outcome results were previously presented.1Objectives:To report FINCH 3 (NCT02886728) results through W52.Methods:This global, phase 3, double-blind, active-controlled study randomised MTX-naïve pts with moderately to severely active RA 2:1:1:2 to oral FIL 200 mg once daily + MTX ≤20 mg weekly, FIL 100 mg + MTX, FIL 200 mg monotherapy (mono) + placebo (PBO), or PBO + MTX up to W52. Comparisons at W52 were not adjusted for multiplicity. Safety was assessed from adverse events and laboratory abnormalities.Results:Of 1249 treated pts, 975 received study drug through W52. FIL efficacy was sustained up to W52. Treatment with FIL + MTX or FIL mono increased proportions of pts achieving ACR20/50/70 and clinical disease remission by DAS28(CRP) Figure). Safety was consistent with W24 data (Table 2).Table 1.Efficacy outcomes at week 52FIL 200 mg + MTX (n = 416)FIL 100 mg + MTX (n = 207)FIL 200 mg(n = 210)MTX(n = 416)ACR20, %75.0***73.4**74.8***61.8ACR50, %62.3***59.4**61.4**48.3ACR70, %47.8***40.1*45.2***29.8mTSSa0.21***0.27*0.23**0.74HAQ-DIb−1.00***−0.97−0.95*−0.88aLeast-squares mean change from baseline.bMean change from baseline.*, p **, p ***, p FIL, filgotinib; mTSS, van der Heijde modified total Sharp score; MTX, methotrexate.Table 2.Safety outcomes through week 52Event, n (%)FIL 200 mg + MTX(n = 416)FIL 100 mg + MTX(n = 207)FIL 200 mg(n = 210)MTX(n = 416)All AEs318 (76.4)164 (79.2)143 (68.1)305 (73.3)Serious AEs26 (6.3)13 (6.3)17 (8.1)28 (6.7)Infection148 (35.6)76 (36.7)75 (35.7)157 (37.7)Serious infection5 (1.2)3 (1.4)5 (2.4)8 (1.9)Herpes zoster6 (1.4)3 (1.4)4 (1.9)4 (1.0)VTE0004 (1.0)MACE (adjudicated)4 (1.0)1 (0.5)2 (1.0)2 (0.5)Malignancya1 (0.2)004 (1.0)NMSC2 (0.5)001 (0.2)Death3 (0.7)b1 (0.5)c00aExcluding NMSC.b1 lupus cardiomyopathy, 1 atypical interstitial pneumonia, 1 non–treatment-emergent cardiovascular death.cDissecting cerebral and vertebral aneurysm.AE, adverse event; FIL, filgotinib; MACE, major adverse cardiovascular event; MTX, methotrexate; NMSC, nonmelanoma skin cancer; VTE, venous thromboembolism.Conclusion:Efficacy of FIL 200 mg + MTX, FIL 100 mg + MTX, and FIL 200 mg mono was sustained through W52, with faster onset1and consistently numerically greater efficacy for FIL 200 vs 100 mg. No new safety signals were observed.References:[1]Westhovens, et al.Ann Rheum Dis.2019;78(Suppl2):259–60.Disclosure of Interests:Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, William Rigby Consultant of: Gilead Sciences, Inc., Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV, Daniel Ching Grant/research support from: AbbVie, Gilead Sciences, Inc., Pfizer, Sanofi, Consultant of: AbbVie, Pfizer, Speakers bureau: AbbVie, William Stohl Grant/research support from: GlaxoSmithKline, Consultant of: Janssen Research & Development, Jonathan Kay Grant/research support from: Gilead Sciences, Inc., Pfizer, Novartis Pharmaceuticals Corporation, Consultant of: Alvotech Suisse AG; Arena Pharmaceuticals, Inc.; Boehringer Ingelheim GmbH; Celltrion Healthcare Co. Ltd.; Merck Sharp & Dohme Corp.; Mylan Inc.; Novartis AG; Samsung Bioepis; Sandoz, Inc; UCB, Inc., Arvind Chopra Grant/research support from: Zydus Pharamceutical Ltd India, Beatrix Bartok Shareholder of: Gilead Sciences Inc., Employee of: Gilead Sciences Inc., Franziska Matzkies Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Zhaoyu Yin Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Ying Guo Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Chantal Tasset Shareholder of: Galapagos (share/warrant holder), Employee of: Galapagos, John Sundy Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Angelika Jahreis Shareholder of: Gilead Sciences, Inc., Employee of: Gilead Sciences, Inc., Neelufar Mozaffarian Shareholder of: Gilead, Employee of: Gilead, Osvaldo Messina Speakers bureau: Amgen; Americas Health Foundation; Pfizer, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Tatsuya Atsumi Grant/research support from: Eli Lily Japan K.K., Alexion Pharmaceuticals, Inc., Bristol-Myers Squibb Co., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Astellas Pharma Inc., Consultant of: Gilead Sciences, Inc., Eli Lilly Japan K.K., UCB Japan Co. Ltd., AbbVie Inc., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Speakers bureau: Eli Lilly Japan K.K., UCB Japan Co. Ltd., Bristol-Myers Squibb Co., AbbVie Inc., Eisai Co. Ltd., Otsuka Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Pfizer Inc., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Takeda Pharmaceutical Co., Ltd., Astellas Pharma Inc., Gerd Rüdiger Burmester Consultant of: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma, Speakers bureau: AbbVie Inc, Eli Lilly, Gilead, Janssen, Merck, Roche, Pfizer, and UCB Pharma

Objectives In RA, the relationship between autoantibody status and treatment response to MTX remains unclear. We investigated the association between autoantibody status and early remission in newly diagnosed RA patients treated with MTX using real-world data. Methods RA-patients initially treated with MTX were selected from an international observational database (METEOR). Patients were stratified into autoantibody-positive (RF- and/or ACPA-positive) or autoantibody negative (RF- and ACPA-negative). The effect of autoantibody status on the chance of achieving remission within 3 to 6 months was analysed using Cox-proportional hazards regression. Results Data from 1826 RA patients were available for analysis. DAS remission was achieved in 17% (318/1826). This was similar in autoantibody-positive [17% (282/1629)] and -negative patients [18% (36/197)]. Hence, autoantibody positivity was not associated with remission [hazard ratio (HR) 0.89, 95% CI 0.57, 1.38]. Similar findings were found when stratified for MTX monotherapy (HR 0.75, 95% CI 0.41, 1.37) or combination treatment (HR 0.76, 95% CI 0.37, 1.54). Good physical function (HAQ < 0.5) was achieved in 33% (530/1590) of all patients. Autoantibody-positivity was also not associated with HAQ < 0.5 (HR 1.05, 95% CI 0.71, 1.57). Conclusion Autoantibody status is not associated with early remission in newly diagnosed RA-patients receiving MTX. This indicates that MTX is effective as an initial treatment strategy regardless of autoantibody status.

Background Using a low cost low infrastructure model, the WHO ILAR COPCORD (Community Oriented Program for Control of Rheumatic Diseases) surveys have covered several population in Asia and Latin America. The reported prevalence of AS based on large sample surveys was 0.2–0.3 in China and 0.12 in Iran. We used the Bhigwan COPCORD model to complete comprehensive surveys at several urban and rural site in India. Objectives To describe the prevalence of SpA in India with a focus on AS Results 51 741 population (66% rural) in 11 sites all over India was screened using a suitable COPCORD core questionnaire and protocol. Stage I survey was carried out in 3 concurrent overlap phases. House to house visit identified respondents with current/past musculoskeletal pain (last 7 days). Paramedics interviewed respondents to map MSK pain and record patient centric outcome including an Indian version HAQ (Phase 2). Clinical evaluation was carried out by rheumatologists with minimal investigations (Phase 3). The diagnosis was clinical. Survey sites and samples were chosen by convenience. Data was centrally processed and analysed using standard software; significant p Conclusions The burden of SpA in India (1.2 billion population) is enormous. Compared to global statistics, the prevalence of clinical AS and psoriatic arthritis in the Indian population appears low. References [1] www.copcord.org [2] Chopra & Nasser. (MSK Burden in Developing World). Best Pract Res Clin Rheumatol2008;22(4):583–604 [3] Joshi & Chopra (Bhigwan COPCORD model) J Rheumatol2009;36:614–22. Acknowledgements The Bone and Joint Decade India, collegue rheumatologists from academia and practise, support staff at COPCORD centres and community Disclosure of Interest None declared

Background Radiographs are a major deterrent in population surveys. COPCORD (community oriented program for control of rheumatic diseases), a low infrastructure low cost model. advocates clinical approach (www.copcord.org). Iran and India completed COPCORD surveys during 2000–2010. Tehran (dominantly Muslim Shia ethnic) is 35° N, 51° E, altitude 3907’ and Pune (dominantly Hindu Maratha ethnic) is 18° N,73° E altitude 1817’. Tehran and Pune represent distinct culture and ethnicity but people in both communities sit and squat (ground). Early reports showed an adjusted prevalence of OA knee was 15.3 in Teheran and 3.4 in Pune. Objectives To determine and compare the age gender specific prevalence of knee OA in an urban survey in Iran and India Methods 8145 population (51% women) in Pune and 10 107 population (53% women) in Tehran were screened (convenience sampling). House to house survey (Phase 1) identified respondents with past(last 3 months) and/or current musculoskeletal (MSK) pain (last 7 days). Trained community volunteers interviewed respondents to map MSK pain and disability (Phase 2). Concurrently, rheumatologists examined cases to make a clinical diagnosis (phase 3). 8.1% in Iran and 16.6% in Pune population were aged 65+years. The age-gender structure in both surveys (phase 1) was similar to the respective national census. Current data pertains to clinically diagnosed symptomatic OA knees (No X-Rays). Crude prevalence (95% confidence intervals) rate is shown. Results The prevalence was 15.1 (14.5, 15.9) in Tehran and 5.6 (5.1, 6.1) in Pune (OR=3.15, 95% confidence interval 2.83, 3.52, p P -value P -value Conclusions Based on a unique community model, urban surveys in Iran and India showed an enormous burden of OA knee. Women suffered more. The burden was strikingly high and unprecedented in Iran. Further research of life styles and risk factors is required to improve understanding of OA in the community. Reference [1] Chopra A. The COPCORD world of musculoskeletal pain and arthritis. Rheumatol (Oxford) 2013. Disclosure of Interest None declared

Background Previous reports on a window of opportunity in rheumatoid arthritis (RA) may be related to the use of slow acting c(onventional) s(ynthetic) DMARDs. We hypothesised that onset of action of therapy might influence whether there is a window of opportunity or whether ‘earlier is just better’. Objectives To investigate the association between symptom duration at treatment onset and the achievement of sustained drug free remission (sDFR) in early RA patients initiating therapy including fast acting prednisone or infliximab, compared to patients initiating csDMARD monotherapy. Methods We analysed the shape (hyperbolic or linear) of the association between symptom duration and achievement of sDFR (DAS Missing DAS were imputed using last observation carried forward. We performed Cox regression analyses with as outcome sDFR and as predictor symptom duration and compared the likelihood ratio tests of a linear model and a model with inclusion of natural cubic spline functions (resulting in a hyperbola), to investigate which model was a better fit for the data. Results In BeSt (n=469), IMPROVED (n=421) and METEOR (n=1653) 54, 110 and 10 patients who started with csDMARD and prednisone or anti-TNF combination therapy, and 53 in BeSt and 15 in METEOR who started with csDMARD monotherapy (no monotherapy in IMPROVED) achieved sDFR. A hyperbolic model did not show a better fit for the data than a linear model (for combination therapy in BeSt p=0.743, IMPROVED p=0.337, METEOR p=0.608, for csDMARD monotherapy in BeSt p=0.609, in METEOR p=0.758). Figure 1 shows the linear association between symptom duration and sDFR per study. These results indicate that the earlier treatment is started, the higher the likelihood of achieving sDFR. However, the data do not suggest that a hyperbolic relationship between treatment onset and outcome sDFR fit the data better. Conclusions Our data suggest that there is no evidence for a window of opportunity in early RA in 3 cohorts. This was not related to use of fast acting combination therapy including prednisone or anti-TNF instead of slow acting csDMARD monotherapy nor was it dependent on strict treatment to target in a clinical trial. It remains that earlier treatment initiation is better when aiming to achieve sDFR. Disclosure of Interest J. van der Pol: None declared, S. A. Bergstra: None declared, N. Riyazi: None declared, Y. Goekoop-Ruiterman: None declared, A. Chopra: None declared, P. Kerstens: None declared, W. Lems: None declared, R. Tsonaka: None declared, T. Huizinga Consultant for: UCB, BMS, Pfizer, Roche, Sanofi-Aventis and Boeringher from outside the submitted work., C. Allaart Grant/research support from: The IMPROVED study was designed by the investigators and financially supported during the first year of follow-up by AbbVie. The BeSt study was supported by the Dutch College of Health Insurances, with an additional grant from Schering-Plough BV and Centocor Inc.

Background: In rheumatoid arthritis (RA), the relationship between autoantibody status and treatment response to methotrexate remains unclear. As methotrexate is the most widely used anti-rheumatic drug in clinical practice, it would be important to know whether the presence of autoantibodies is associated with better treatment response, since patients may benefit from treatment tailored to “autoantibody status”. Objectives: We investigated the relationship between autoantibody status and remission in newly diagnosed RA-patients treated with first-line methotrexate. Methods: RA-patients initially treated with methotrexate were selected from an international observational database (METEOR). Patients were stratified into autoantibody-positive (rheumatoid factor (RF)- and/or anti-citrullinated-protein antibodies (ACPA)-positive) or -negative (RF- and ACPA- negative). The effect of autoantibody status on the chance of achieving remission within 3 to 6 months was analysed using Cox-proportional hazards regression. Results: Data from 1826 RA-patients were available for analysis. DAS remission was achieved in 17% (318/1,826). This was similar in autoantibody-positive (17% (282/1629)) and -negative patients (18% (36/197)). Hence, autoantibody positivity was not associated with remission (HR0.89, 95%CI 0.57;1.38). Similar findings were found when stratified for methotrexate monotherapy (HR0.75, 95%CI 0.41;1.37) or combination treatment (HR0.76, 95%CI 0.37;1.54). Good physical function (HAQ Conclusions: In conclusion, we found that autoantibody status was not associated with early remission in newly diagnosed RA-patients receiving methotrexate in real-world clinical practice. These results do not support the hypothesis that treatment should be tailored to “autoantibody status” when it comes to initiating methotrexate therapy as first-line anti-rheumatic treatment. Rather, our results indicate that that methotrexate is effective as primary anchor drug regardless of autoantibody status. Disclosure of Interest: None declared

The maiden WHO ILAR COPCORD (community oriented program for control of rheumatic diseases) Bhigwan (1996–2014) demonstrated that musculoskeletal (MSK) pain was the commonest self-reported ailment in the community, soft tissue rheumatism, ill-defined MSK symptoms and osteoarthritis (OA) were the predominant disorders and about 10% cases suffered from inflammatory arthritis. The burden of rheumatoid arthritis (RA) was high with point prevalence of 0.7%. Bone and joint decade (BJD) India conducted several standardized and uniform surveys (2004–2010) all over India and collected data from over 55,000 persons at 12 sites. The pooled age sex adjusted (India census population 2001) prevalence reported by the recent surveys was – RA (0.34), OA knees (3.34), undifferentiated inflammatory arthritis (0.22), Spondyloarthritis (0.23), ankylosing spondylitis (0.03), psoriatic arthritis (0.01) soft tissue rheumatism (1.39), gout (0.05) lupus (0.01); prevalence percent in parenthesis. Several forms of collagen vascular disorders and vasculitis are described in hospital based case series. Musculoskeletal infections including tuberculosis remain an important clinical burden. The 2006 India Chikungunya epidemic has put an additional burden of chronic MSK pain and arthritis. The recently launched national health programs pertaining to non-communicable diseases, rural and women health does not even mention rheumatic diseases thus there is urgent need to study the burden of rheumatic diseases and its impact on society.

Background Genetic and environmental risk factors for rheumatoid arthritis (RA) are population dependent and may affect disease expression. Therefore, we studied tender and swollen joint involvement in patients newly diagnosed with RA in four countries and performed a subanalysis within countries to assess whether the influence of autoantibody positivity affected disease expression. Methods Patients with symptom duration

Background Aiming at rapid decrease of disease activity, there has been a trend to start with higher doses of methotrexate (MTX) in newly diagnosed rheumatoid arthritis (RA) patients, both as monotherapy and in combination with other antirheumatic drugs (DMARDs). We hypothesized that in combination with other very effective medication, there might be no additional benefit of high over low doses of MTX. Objectives To compare early clinical response to high versus low doses of MTX in mono- and combination therapy in DMARD naive early RA patients. Methods RA patients included in the observational international METEOR cohort with symptom duration ≤5 years, time between diagnosis and first visit ≤2 months, MTX prescribed as (part of) first treatment, no medication change within 3 to 6 months after treatment start and available outcome data on disease activity, were selected. Patients were divided into 4 medication groups: MTX monotherapy, MTX + synthetic (cs)DMARDs, MTX + oral glucocorticoid (+ possibly csDMARDs) or MTX + biologic (b)DMARDs (+ possibly csDMARDs). Missing data were imputed using multivariate normal imputation. MTX dose was dichotomized: low dose ≤10 mg/week; high dose ≥15 mg/week. A propensity score (PS) was calculated to adjust the relationship between MTX dose and outcome for potential confounding by indication. Linear mixed model analyses for DAS, DAS28, and HAQ were performed for each medication group, with MTX-dose and time (days between assessment visit and baseline assessment) as co-variates. Associations were adjusted for the PS. Random intercept and slope were used to account for irregular time intervals between visits. Results Patients who started on MTX monotherapy had lower baseline disease activity and fewer were erosive and autoantibody positive; other baseline characteristics were comparable between medication groups. The number of patients on combination therapy with bDMARDs was too small to perform analyses (26 visits in 11 patients). For patients starting on MTX monotherapy, MTX+csDMARDs or MTX+glucocorticoids, the PS-adjusted effects of MTX-dose (high vs low) on DAS, DAS28 and HAQ were small and not clinically meaningful. The unadjusted main associations between MTX-dose and outcomes were often in opposite direction and/or much larger than the PS adjusted associations, suggesting that confounding by indication indeed plays a role and that (at least some) correction was achieved by adjusting for the PS (table 1). Conclusions In a daily practice derived database in DMARD-naive early RA patients, we found no early clinical benefit of high over low initial MTX doses, neither for MTX monotherapy nor for combination therapy with MTX and csDMARDs or glucocorticoids. This seems to contradict a general trend over time to start higher MTX-doses. Disclosure of Interest None declared

Background Diet in RA is generally considered to be inadequate/inappropriate. Rheumatologists often neglect this important patient concern. ACR/EULAR guidelines do not provide adequate advice. Ayurveda (ancient India medicine system) with highly restricted diet is popular with Indian patients. Objectives To evaluate diet adequacy in patients of RA in our setting Methods 139 consenting patients (ACR 1987 classified)on long term supervised care and 165 unmatched healthy subjects (mean age 37.7 years) were interviewed in no particular order as per protocol; cross sectional design. A 10 day diet recall period and a-priori validated questionnaires was used. National (India) recommended daily allowance (RDA) and diet analysis (web based and food composition tables) methods were used.Standard CRF captured clinical data [mean pain VAS 4.6 cms,mean HAQ score (Indian version) 6.5]. Standard statistical analysis (SPSS) was done; significant p Results Table 1 (women) and 2 (men) show average daily energy expenditure and consumption of selected food items, RDA and p values (on comparison: P (1) for patient versus control, P (2) for patient versus RDA: p by Mann Whitney). Compared to RDA, patient consumption was significantly higher for most of the items except K; includes calcium, phosphorus, zinc, iron, folic acid, vitamin B group (data not shown in Tables). When compared to healthy subjects, consumption was significantly lower for female patients but not different for men (except for K). Reduction in diet K in RA group was more pronounced for women. All patients tested normokalemic (mean serum K+ 4.37 mEq/l). No meaningful correlation between diet components and disease measures (data not shown).Food avoidance patterns identified a-priori did not seem to impact disease measures (data not shown). 44% RA and 77% controls consumed vegetarian diet (excluding eggs). Patient dependence for diet recall and measure was the important limiation. Conclusions The diet of RA patients seemed adequate except for an intriguingly low K. We speculate that patients eat lesser vegetables and fruits that source K. K sub serves several physiological functions that may be deranged in RA and contribute to disease progression. This would need further investigation. Acknowledgements In contrary to our expectations and reassuringly, the diet of RA patients seemed adequate except for an intriguingly low potassium which should be investigated. We speculate that patients eat lesser vegetables and fruits that source potassium. Disclosure of Interest None declared

Background Disease activity indices (DAI) are used to guide immunosuppressive therapy in rheumatoid arthritis (RA). The inclusion of patient global assessment (PGA) in these indices has been questioned as it conveys mainly disease impact rather than disease activity. Objectives To determine the influence of PGA on patient disease states and to determine PGA correlations with inflammatory parameters, disease impact, demographic, clinical and contextual factors.

Disease activity and quality of life (QOL) including functional status in rheumatoid arthritis (RA) is influenced by several ethnic, cultural and other factors. Standard of care management should cater for country specific needs. Objectives To assess and compare clinical disease characteristics and health status in patients with RA from two countries, India and Iran. Material and methods A cross-sectional survey of 140 RA patients (Indian70 and Iranian70) was chosen from rheumatology outpatients (Bandar Abbas, Iran and Pune, India) in random manner. One of the authors evaluated all patients under Rheumatologist supervision. Standard evaluation was as per current American College of Rheumatology guidelines and included a 68/66 joint count and laboratory tests. Health assessment questionnaire (CRD Pune version HAQ) and SF36v2 was utilized to assess functional and health status. While Iranian patients were all Muslims, the Indian patients were predominantly Hindu. Results The groups matched well for age, gender, duration of disease and rheumatoid factor. Patients in Iran had less years of education as compared to patients from India ( p Conclusions Though there were some important differences in pain perception, joint counts and QOL, the study cohorts of RA belonging to the Iranian and Indian ethnicity were similar for disease activity (DAS) and functional status (HAQ).

Objective To evaluate whether chloroquine (CQ) is more effective than meloxicam for treating early musculoskeletal pain and arthritis following acute chikungunya (CHIK) virus infection. Methods During the 2006 CHIK epidemic, 509 rural community cases of acute CHIK virus infection were identified in the district of Sholapur in India. Seventy consenting adult patients (seropositive for IgM/IgG anti-CHIK antibody) with early persistent musculoskeletal pain and arthritis were randomized into a 24-week, 2-arm, parallel efficacy trial of CQ (250 mg/day) and meloxicam (7.5 mg/day). Assessors completed a rheumatology evaluation in a blinded manner and collected blood samples in the patients' homes, as per protocol. Laboratory parameters included serum cytokine assay (interleukin-6 [IL-6], interferon-γ [IFNγ], tumor necrosis factor α, CXCL10/IFNγ-inducible protein 10, and IL-13). Twenty-two patients who failed to meet the eligibility criteria (low pain cohort) were also followed up with similar evaluations. An intent-to-treat analysis was completed. At baseline, the 2 groups (38 patients randomized to receive CQ and 32 patients randomized to receive meloxicam) were well matched. Results There were no significant efficacy differences between the meloxicam group and the CQ group (mean changes in the visual analog scale score for pain −3.9 and −4.2, respectively). Patients improved significantly. Cytokine levels remained several-fold increased, were disproportionate to the clinical response, and were not different from those in the low pain cohort. Seven patients withdrew. Adverse events were mild and infrequent. Conclusion This exploratory community intervention trial failed to identify an advantage of CQ over meloxicam to treat early musculoskeletal pain and arthritis following acute CHIK virus infection, but therapeutic efficacy of CQ was not ruled out. The inflammatory cytokine response was intense and was not consistent with clinical status.

Background Aiming at rapid decrease of disease activity, there has been a trend to start with higher doses of methotrexate (MTX) in patients newly diagnosed with rheumatoid arthritis (RA), both as monotherapy and in combination with other antirheumatic drugs. We aimed to study the relationship between clinical response and MTX dose as monotherapy or combination therapy in patients with early RA. Methods Disease-modifying anti-rheumatic drug (DMARD)-naive patients with early RA, from a large international observational database, the METEOR database, were selected if MTX was part of their initial treatment. Patients were divided into four groups: MTX monotherapy, MTX + convention synthetic (cs)DMARDs, MTX + glucocorticoids or MTX + biologic (b)DMARDs. MTX dose was dichotomized: low dose ≤10 mg/week; high dose ≥15 mg/week. Linear mixed model analyses for the Disease Activity Score (DAS), DAS in 28 joints (DAS28) and Health Assessment Questionnaire (HAQ) were performed in each medication group, with MTX dose and time as covariates. Outcomes were assessed from baseline until 3–6 months follow up. Associations were adjusted for potential confounding by indication using propensity score (PS) modelling. Results For patients starting MTX monotherapy (n = 523), MTX + csDMARDs (n = 266) or MTX + glucocorticoids (n = 615), the PS-adjusted effects of MTX dose (high versus low) on the DAS, DAS28 and HAQ were small and not clinically meaningful. Patients starting MTX + bDMARDs were disregarded due to low numbers (n =11). Conclusions In patients newly diagnosed with RA, no clinical benefit of high compared to low initial MTX doses was found for MTX monotherapy or for MTX combination therapy with csDMARDs or glucocorticoids. Electronic supplementary material The online version of this article (doi:10.1186/s13075-017-1468-9) contains supplementary material, which is available to authorized users.