Effect of initiating biologics compared to intensifying conventional DMARDs on clinical and MRI outcomes in established rheumatoid arthritis patients in clinical remission: Secondary analyses of the IMAGINE-RA trial

Background:Sustained remission (SR) is an ultimate treatment goal in the management of patients with rheumatoid arthritis (RA) (1) and is associated with better RA prognosis, reflected by the quality of life, physical function and radiographic progression (2).Objectives:To investigate the prevalence and predictors of SR in RA patients.Methods:A longitudinal prospective study of patients with RA. At the inclusion, the patients were in remission DAS28 ESR≤ 2.6 for at least 6 months. A B-mode and power doppler (PD) ultrasound of 42 joints and 20 tendons was performed. Synovial hypertrophy (SH) and tenosynovitis in B-mode and PD were defined and scored from 0 to 3 using the OMERACT. The CDAI, SDAI, Boolean remission criteria, the health assessment questionnaire (HAQ) and the radiological Sharp score were calculated. Then, the DAS28 erythrocyte sedimentation rate (ESR) was evaluated at 6 and 12 months. SR was defined as the persistence of a DAS28 ESR≤2.6 at 6 or 12 months without any change in RA therapy during the follow-up. Unstable remission (UR) was defined either as DAS28 ESR > 2.6 at 6 or 12 months or an increase in RA therapy because of a relapse during the follow-up.Results:At baseline, thirty-seven patients were included. At 6 and 12 months, 28 and 24 patients completed follow-up, respectively. In decreasing order, Boolean remission (92.2%), DAS28ESRremission (85.7%), SDAI remission (85%) and CDAI remission (83.3%) achieved SR at 6 months. At 12 months, SR was found in 100% in Boolean remission, 87.5% in SDAI remission, 86.7% in CDAI remission and in 79.7% in DAS28 ESR remission. At 6 months, only the ESR (17mm/1h in SR versus 32 mm/1h in UR, p=0.04) was associated with SR. The disease duration, remission duration, swollen and tender joints, DAS28ESR, HAQ, rheumatoid factor, radiological Sharp score and ultrasound parameters weren’t associated with SR. At 12 months, the squeeze test (15% in SR vs 80% in UR, P=0.01), the ESR (15 mm/1h in SR versus 30 mm/1h in UR, p=0.03), the Boolean remission (61.1% in SR versus 0% in UR, p=0.04) and the DAS28ESR (mean: 1.8 in SR versus 2.5 in UR, P=0.01) were associated with SR. However, no association was found with radiological Sharp score and ultrasound parameters. On multivariate analysis, the ESR (OR=1.13, CI95%=1.01-1.2, p=0.03) and the Squeeze test (OR=21.3, CI95%=1.7-263, p=0.01) were predictors of SR, at 12 months.Conclusion:At 6 and 12 months, 79.7%-85.7% of patients in DAS28 ESR remission achieved sustained remission, respectively. Boolean and DAS28 ESR remission were associated with SR. Unlike DAS28 ESR, Boolean remission seems to reflect more the SR. The squeeze test and the ESR were predictors’ factor. However, the radiological and the ultrasound parameters didn’t show any association.References:[1]Ajeganova S, Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017;9(10):249-62.[2]Xie W, Li J, Zhang X, Sun X, Zhang Z. Sustained clinical remission of rheumatoid arthritis and its predictive factors in an unselected adult Chinese population from 2009 to 2018. Int J Rheum Dis. 2019;22(9):1670-8.Disclosure of Interests:None declared

Download Full-text

CP-078 Optimisation of biological therapy in established rheumatoid arthritis patients in real life clinical practice

European Journal of Hospital Pharmacy ◽

10.1136/ejhpharm-2016-000875.78 ◽

2016 ◽

Vol 23 (Suppl 1) ◽

pp. A34.2-A34

Author(s):

M Cárdenas ◽

P Font ◽

S De la Fuente ◽

MC Castro-Villegas ◽

M Romero-Gómez ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Practice ◽

Biological Therapy ◽

Real Life ◽

Established Rheumatoid Arthritis

Download Full-text

AB0235 RITUXIMAB (BIOSIMILAR) IN RHEUMATOID ARTHRITIS: CLINICAL & IMMUNOLOGICAL RESPONSE TO VARYING DOSES- EXPERIENCES FROM A TERTIARY CARE CENTER IN SOUTH INDIA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.3794 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 1143.2-1144

Author(s):

J. Antony ◽

R. Sankaralingam ◽

R. Maheshwari ◽

B. Chilukuri ◽

S. Chinnadurai

Keyword(s):

Rheumatoid Arthritis ◽

Computed Tomography ◽

Interstitial Lung Disease ◽

Complete Remission ◽

Lung Disease ◽

Clinical Remission ◽

Clinical Indication ◽

Fixed Dose ◽

Double Negative ◽

Lung Involvement

Background:Rituximab (RTX) is a chimeric monoclonal antibody against CD20. There is a paucity of studies done with RTX biosimilars. This is a Retrospective and Observational study from January 2018 to December 2019 done in the Department of Clinical Immunology & Rheumatology, Sri Ramachandra Institute of Higher Education and Research, Chennai, India.Objectives:1.To find the effects of varying doses of RTX in attaining clinical remission in RA.2.To find if CD19, CD20 & IgG help in identifying impending flare & if these levels help in deciding the timing of the next dose of RTX.Methods:Rheumatoid arthritis (RA) cases who were given Rituximab from January 2018 were selected. Clinical Response at 6 & 12 months & wherever feasible at 18 & 24 months was assessed by Simplified Disease Activity index (SDAI). RTX initial dose was given at 0 and 14 days followed by fixed dose at six months interval.CD19, CD20 B cell count, IgG levels were tested in patients in whom it was feasible at baseline & 6 months (select patients at 12,18 &24 months). Patients were divided in to 5 groups (DMARD naïve, DMARD resistant & Interstitial Lung disease (ILD) [Lung involvement>20% in Computed Tomography (CT)]) and (500mg & 1g). Patients were divided into three clinical groups, (DMARD naïve, DMARD resistant & Interstitial Lung disease (ILD) [Lung involvement>20% in Computed Tomography (CT)]) and two treatment groups (500mg & 1g) based on clinical indication for RTX and dose of RTX, respectively. In patients with ILD, CT scan & FVC were compared at baseline & 12 months.Results:29 patients (seropositive 28 (RF/Anti CCP/BOTH+VE), seronegative 1) were given RTX for RA over a 2-year period of which 12 had CD19, CD20 & IgG tested. Mean SDAI reduction from baseline to 6 months post treatment was 30%, 32% & 14% while complete remission (SDAI<3.3) was attained in 100%, 18% & 20% in DMARD naïve, DMARD resistant & ILD groups, respectively. CD19, CD20 & IgG reduced from 18.6%, 18.4% & 18.53g/L to 3.7%,3.7% & 9.7g/L respectively FVC improved from 62.4% to 67% at 12. The percentage of patients with lung involvement >20% reduced from 53.3% to 46.7%. Flare was observed in one patient who received 500mg RTX. CD19, CD20 & IgG levels increased from 7.9%, 8% & 9.8g/L to 27%, 25% & 13g/L respectively. 3 patients in the 1g group were followed up at 12,18 & 24 months. In these patients there were no flares or worsening symptoms. 1 patient was double negative for RF & Anti CCP and this patient did not attain clinical remission even after 2 doses of 1g RTX.Conclusion:[1]Patients with early arthritis (diagnosis made within 1 year) and who were DMARD naïve had an excellent response to Rituximab.[2]Complete remission was observed in more patients the 1g compared to 500mg group.[3]Reduction in CD19 & CD20 was associated with significant reduction in the SDAI score.[4]There was no significant reduction of CD19 & CD20 with 500mg dose of Rituximab where either a partial remission or mild flare was observed.[5]There was reduction in the lung involvement to less than 20%(CT) in few patients with 1g dose.[6]Double negative Rheumatoid arthritis poorly responded to Rituximab.[7]The positive effects of 1g Rituximab could be noted up to 24 months.[8]Flare of RA was associated with significant increase in CD19 & CD20.Disclosure of Interests:None declared

Download Full-text

OP0220 ASSESSING THE EFFECT OF INCREASED BODY MASS INDEX ON RESPONSE TO TNF INHIBITORS IN ESTABLISHED RHEUMATOID ARTHRITIS: RESULTS FROM THE METEOR DATABASE

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.1084 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 137.1-137

Author(s):

M. Dey ◽

S. S. Zhao ◽

R. J. Moots ◽

R. B. M. Landewé ◽

N. Goodson

Keyword(s):

Rheumatoid Arthritis ◽

Body Mass Index ◽

Body Mass ◽

Personalised Medicine ◽

Normal Weight ◽

Sensitivity Analyses ◽

Established Rheumatoid Arthritis ◽

Eular Response ◽

Significant Difference ◽

Das28 Remission

Background:Rheumatoid arthritis (RA) is associated with increased body mass index (BMI)- 60% of patients are either overweight or obese. Obesity in RA has been shown to predict reduced response to biologic therapy including tumour-necrosis-factor inhibitors (TNFi) [1]. However, it is not clear whether increased BMI influences response to all TNFi drugs in RA.Objectives:1.To explore whether BMI is associated with response to TNFi in patients with established rheumatoid arthritis (estRA), including those newly-starting on these drugs.Methods:Participants with estRA (>1year since diagnosis) taking biologic medications, registered on METEOR (international database of RA patients), 2008-2013, were included. EULAR response, DAS28 remission (including components), and treatment regimens were recorded at baseline, 6, and 12 months. WHO definitions of overweight (BMI≥ 25) and obese (BMI≥30) were explored as predictors of TNFi response (good EULAR response and DAS28 remission) using normal BMI as comparator. Logistic and linear regression models (controlling for age, gender, smoking, and baseline outcomes) and sensitivity analyses were performed. Subgroup analyses were performed for grouped TNFi and individual TNFi (infliximab, IFX; adalimumab, ADA; etanercept, ETN).Results:247 patients with estRA were taking a biologic at 6 months, and 231 patients were taking a biologic at 12 months. Obese patients taking any biologic were significantly less likely to achieve DAS28 remission (OR 0.33 [95%CI 0.12-0.80]) or good EULAR response (OR 0.37 [95%CI 0.16-0.81]) after 6 months, compared to those of normal BMI; this was also demonstrated in those co-prescribed methotrexate (DAS28 remission: OR 0.23 [95%CI 0.07-0.62]; good EULAR response: OR 0.39 [95%CI 0.15-0.92]). These associations did not remain statistically significant at the 12 months assessment.Regarding specific anti-TNF therapies, RA patients treated with monoclonal antibody (-mab) TNFis (IFX/ADA/ GOL) were significantly less likely to achieve good EULAR response at 6 months if they were obese RA (n=38), compared to those of normal weight (n=44) (OR 0.17 [95%CI 0.03-0.59]). A similar non-significant difference was demonstrated for DAS28 remission, and 12-month remission. Specifically, obese individuals were significantly less likely to achieve good EULAR response at 6 months with IFX (OR 0.09 [95%CI 0.00-0.61]; n=20), and significantly less likely to achieve DAS28 remission at 6 months when newly-starting ADA (OR 0.14 [95%CI 0.01-0.96]; n=17), compared to those of normal weight. There were no significant differences in remission outcomes between individuals of different BMI taking ETN. A small number of individuals stopped taking their respective biologic after 6months; reason for cessation was not recorded.Similar outcomes were seen in patients already established on anti-TNF therapy, with overweight and obese individuals less likely overall to be in DAS28 remission at all time points.Conclusion:In established RA, obesity is associated with reduced treatment response to -mab TNFi. No association between increased BMI and response to ETA was observed. Using BMI to direct biologic drug choice could prove to be a simple and cost-effective personalised-medicine approach to prescribing.References:[1]Schäfer M, Meißner Y, Kekow J, Berger S, Remstedt S, Manger B, et al. Obesity reduces the real-world effectiveness of cytokine-targeted but not cell-targeted disease-modifying agents in rheumatoid arthritis. Rheumatology. 2019 Nov 20.Disclosure of Interests:Mrinalini Dey: None declared, Sizheng Steven Zhao: None declared, Robert J Moots: None declared, Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Nicola Goodson: None declared

Download Full-text

AB0189 ASSESSMENT OF POWER DOPPLER SYNOVITIS IN RHEUMATOID ARTHRITIS PATIENTS WITH CLINICAL REMISSION

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.6064 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1394.2-1394

Author(s):

R. Fakhfakh ◽

N. El Amri ◽

K. Baccouche ◽

H. Zeglaoui ◽

E. Bouajina

Keyword(s):

Rheumatoid Arthritis ◽

Functional Capacity ◽

Clinical Remission ◽

Power Doppler ◽

Health Assessment ◽

Disease Flare ◽

Synovial Hypertrophy ◽

The Mean ◽

Grade 3 ◽

Subclinical Synovitis

Background:Ultrasound-detected synovitis, mainly synovial Doppler signal, has shown predictive value in relation to radiographic damage progression and disease flare or relapse in rheumatoid arthritis (RA) patients with clinical remission.Objectives:The aim of the study was to analyze the correlation between power Doppler scores and clinical/laboratory and radiographic data in clinical remission RA patients.Methods:Cross-sectional study including patients with RA in clinical remission defined by: DAS28ESR ≤ 2.6, without disease flare or changes in therapy in the previous 6 months. Each patient underwent ultrasound: B-mode and PD assessments of 36 joints and 20 tendons in the Rheumatology Department over a period of 6 month. Synovitis and tenosynovitis were defined and scored according to the Outcome Measures in Rheumatology Clinical Trials (OMERACT). Radiological measurements included the modified Sharp/van der Heijde method (SHS). Functional capacity was assessed by the Health Assessment Questionnaire (HAQ).Results:Thirty two patients were enrolled, the mean age was 53.7±13.4 and 75% were female. The mean disease duration was 15 years ± 8.8. Subclinical synovitis were the most frequent in wrist (56.3%), 2ndmetacarpophalangeal joints (28.1%) and 2ndmetatarsophalangeal joints (29%). The mean subclinical synovitis/ tenosynovitis numbers was 4±3.1 per patient. Synovial hypertrophy and B mode tenosynovitis were detected in 93.8%: 71.3% had a grade = 2 and 9.8% had a grade= 3. Total B mode score was correlated only with the SHS score in the feet (r: 0.4, p: 0.03). PD signal was detected in 62.5% of patients: 37.5% had a grade =2 and 9.4% had a grade= 3. Total PD score was correlated with DAS28 (r:0.42, p:0.02), the SHS score in the hands (r:0.39, p:0.03) and in the feet (r:0.5, p:0.007), synovial hypertrophy (r:0.6, p:0.0001) and HAQ (r:0.32, p:0.06). No correlation was found with CDAI, SDAI, swollen joint counts, tender joint counts, patient global health assessment, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor and anti-cyclic citrullinated peptide, biologic treatment.Conclusion:Synovial hypertrophy and PD signal were frequent in RA remission. PD signal was associated with RA activity, radiologic damage and functional capacity.References:[1]Yan Geng & Jingjing Han & Xuerong Deng and al. Presence of power Doppler synovitis in rheumatoid arthritis patients with synthetic and/or biological disease-modifying anti-rheumatic drug-induced clinical remission: experience from a Chinese cohort. Clinical Rheumatology 2014. DOI 10.1007/s10067-014-2634-yDisclosure of Interests:None declared

Download Full-text

FRI0116 COMPARABLE EFFICACY AND SAFETY OF TWO REGIMENS OF RHEUMATOID ARTHRITIS TREATMENT WITH TOFACITINIB: DATA FROM RUSSIAN NATIONAL REGISTRY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.3662 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 639-639

Author(s):

A. Babaeva ◽

E. Kalinina ◽

E. Nasonov ◽

V. Mazurov ◽

G. Lukina ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Therapy Group ◽

Target Therapy ◽

Combined Therapy ◽

National Registry ◽

Comparable Efficacy ◽

Efficacy And Safety ◽

National Guidelines ◽

Therapy Regimen ◽

Conventional Dmards

Background:Current EULAR and national guidelines recommend use of synthetic target drug Tofacitinib (TOFA) for active rheumatoid arthritis (RA) treatment in case of resistance or intolerance to metotrexate (MTX) or other conventional DMARDs. Two treatment regimens are approved: TOFA mono-therapy and combination with conventional DMARD, preferably with MTX.Objectives:Aim of presented study was to compare efficacy and safety of TOFA given in two regimens: as mono-therapy and in combination with MTX.Methods:We analyzed data from Russian national registry of RA. 450 patients (pts) treated with TOFA in dose 10 mg daily have been enrolled in this investigation. Among them 169 pts have composed TOFA mono-therapy group (mono) and 281 pts treated with TOFA plus MTX have been included in combo-therapy group (combo). Period of treatment varied from 6 months to 3 years and even more. Treatment efficacy was evaluated on the basis of clinical and laboratory indices of RA activity: CDAI, SDAI, DAS28, HAQ, GPA (general pain assessment), TJC, SJC, CRP, ESR monthly during first 6 months, than in 1,2,3 years and after 3 year period of treatment.Results:There were no significant differences in pts demographic characteristic and disease longevity and/or severity in two separated groups. Majority of baseline indices were identical in these groups aside from SDAI, CRP (were higher in combo-group) and HAQ (was higher in mono-group). Pts monitoring have shown dramatically decrease of all used indices during the first several months of therapy in both groups. Moreover all clinical and laboratory parameters after 6-months treatment were comparable in mono- and combo- groups. Positive dynamics remained during further 3-year period in both groups. Significant differences between baseline and ultimate data after 3 year course therapy were revealed in CDAI, SDAI, DAS28, HAQ, GPA, TJC, SJC, CRP, ESR in both groups. In particular DAS28 index decreased from 5.38±0.08 to 2.88±0.07 (p<0.05) in mono-group and from 5.54±0.09 to 3.40±0.21 (p<0.05) in combo-group. Along with this comparing of endpoints in two analyzed groups have shown that levels of CDAI, SDAI, GPA were significant higher in combo-group than in mono-group (p<0.05). Adverse effects were registered in 4.73% pts from mono-group and in 4.98% pts from combo-group (p>0.05). Spectrum of adverse reactions was similar in compared groups: respiratory infection (in 2.96% and 3.36% cases respectively) and herpes infection (in 0.59% and 0.71% cases, respectively) were registered predominantly.Conclusion:Data gained from National RA registry have demonstrated that treatment with TOFA in mono-therapy regimen has the comparable efficacy with regimen of combined therapy, included MTX and TOFA. Safety of both regimens can be qualified as good. Obtained results confirm high efficacy and safety of target therapy with TOFA and prove the recommendation for use it in different regimens – mono-therapy or combination with MTX.References:[1]Smolen JS, et al. Ann Rheum Dis. 2017;0:1–18. doi:10.1136/annrheumdis-2016-210715[2]Boyle DL, et al. Ann Rheum Dis. 2015;74:1311-1316. doi:10.1136/annrheumdis-2014-206028Disclosure of Interests:Aida Babaeva: None declared, Elena Kalinina: None declared, Evgeny Nasonov Speakers bureau: Lilly, AbbVie, Pfizer, Biocad, R-Pharm, V Mazurov: None declared, Galina Lukina Speakers bureau: Novartis, Pfizer, UCB, Abbvie, Biocad, MSD, Roche, Antonina Davydova: None declared, Irina Semizarova: None declared, Olga Slyusar: None declared, Tatyana Rasevich: None declared, Ruzana Samigullina: None declared, Diana Abdulganieva: None declared

Download Full-text