scholarly journals Real-World Comparative Effectiveness and Safety of Tofacitinib and Baricitinib in Patients with Rheumatoid Arthritis

Author(s):  
Naoki Iwamoto ◽  
Shuntaro Sato ◽  
Shota Kurushima ◽  
Toru Michitsuji ◽  
Shinya Nishihata ◽  
...  

Abstract Objective: To compare the efficacy and safety of tofacitinib and baricitinib in patients with RA in a real-world setting.Methods: A total of 242 patients with RA who were treated with tofacitinib (n=161) or baricitinib (n=81) were enrolled. To avoid confounding, we performed propensity score matching based on multiple baseline characteristic variables, and then 80 baricitinib-treated patients and 57 tofacitinib-treated patients were extracted for direct comparison. Their clinical disease activity and AEs were evaluated for 24 weeks. Results: The mean DAS28-ESR change from baseline to 24 weeks were 1.60 (tofacitinib) and 1.46 (baricitinib). There was no significant difference in the clinical response between two groups. The efficacy was not significantly changed in the patients without concomitant MTX use in both groups, but the concomitant MTX use showed better clinical efficacy in the cases of baricitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response as revealed by a multivariable logistic analysis differed. The concomitant oral steroid use was independently associated with the achievement of DAS-low disease activity in both groups, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used was also associated. Conclusions: Our findings indicate that tofacitinib and baricitinib had comparable continuing efficacies and safety profiles. However, the influence of clinical characteristics on the treatment response differed. Direct comparison provides useful information to optimal use of JAK inhibitors in real-world settings.

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Naoki Iwamoto ◽  
Shuntaro Sato ◽  
Shota Kurushima ◽  
Toru Michitsuji ◽  
Shinya Nishihata ◽  
...  

Abstract Objective To compare the efficacy and safety of tofacitinib and baricitinib in patients with RA in a real-world setting. Methods A total of 242 patients with RA who were treated with tofacitinib (n = 161) or baricitinib (n = 81) were enrolled. We evaluated efficacy and safety between tofacitinib and baricitinib using multivariable analyses to avoid confounding. Their clinical disease activity and AEs were evaluated for 24 weeks. Results The mean (SD) DAS28-ESR change from baseline to 24 weeks was 1.57 (1.55) (tofacitinib) and 1.46 (1.36) (baricitinib). There was no significant difference in the clinical response between the two groups (adjusted mean difference, 0.04; 95% CI, −0.35 to 0.28). The efficacy was not significantly changed in the patients without concomitant MTX use in both groups, but the concomitant MTX use showed better clinical efficacy in the cases of baricitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response as revealed by a multivariable logistic analysis differed. The concomitant oral steroid use was independently associated with the achievement of DAS-low disease activity in the tofacitinib group, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used was associated. Conclusions Our findings indicate that tofacitinib and baricitinib had comparable continuing efficacies and safety profiles. However, there is a possibility that the influence of clinical characteristics on the treatment response differs. The comparison provides useful information to the optimal use of JAK inhibitors in real-world settings.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 581.3-581
Author(s):  
N. Iwamoto ◽  
T. Suzuki ◽  
A. Okada ◽  
K. Fujikawa ◽  
T. Aramaki ◽  
...  

Background:Tofacitinib is a non-selective first-generation JAK inhibitor and baricitinib was approved for the treatment of Rheumatoid arthritis several years after approve of tofacitinib. Randomized controlled trials have shown good treatment response for RA in these two drugs. However, the evaluation of these two drugs in real-world setting have been rarely reported, moreover, until now, no published data of a direct comparison among JAK inhibitors in RA have been available.Objectives:To compare the efficacy and safety of the JAK inhibitors tofacitinib and baricitinib in patients with rheumatoid arthritis (RA) by using propensity score matching in a real-world setting.Methods:A total of 242 patients with RA who were treated with tofacitinib (n=161) or baricitinib (n=81) were enrolled. To avoid confounding, we performed propensity score matching based on multiple baseline characteristic variables, and then 80 baricitinib-treated patients and 57 tofacitinib-treated patients were extracted for the direct comparison. A mixed effect model with a repeated measures analysis of variance (ANOVA) was performed to ascertain whether there were significant differences in clinical efficacy between the two treatment groups during the treatment period.Finally, We evaluated the predictive factor of clinical responses by performing univariate and multivariable logistic regression analyses.Results:The mean delta disease activity scores (DAS)28-ESR from baseline to 6 months were −1.60 (tofacitinib) and −1.46 (baricitinib). The remission rate defined by the DAS28-ESR at 24 weeks were 21.1% (tofacitinib) and 25.0% (baricitinib). There was no significant difference in the clinical response between the baricitinib-treated and tofacitinib-treated groups. Although there was no significant difference, the concomitant use of methotrexate (MTX) showed better clinical efficacy in the cases of baricitinib treatment as compared with in the case of tofacitinib treatment. In both groups, the most common AE was herpes zoster infection, and the AE rates were similar between the two groups. However, the predictive factors contributing to clinical response differed. The concomitant use of oral steroid was independently associated with the achievement of DAS-low disease activity in both groups, whereas in the baricitinib group, the number of biological and/or targeted synthetic DMARDs previously used and the DAS28-ESR at the time of initiation were associated with DAS-low disease activity.Conclusion:This study indicate that tofacitinib and baricitinib had comparable efficacies and safety profiles in a real-world setting. However, the influence of clinical characteristics on the treatment response differed between these two drugs. Direct comparison between two JAK inhibitors provide useful information to optimal use of JAK inhibitors in real-world settings.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 540.1-540
Author(s):  
M. Schmalzing ◽  
A. Askari ◽  
T. Sheeran ◽  
D. Walsh ◽  
J. De Toro Santos ◽  
...  

Background:Sandoz etanercept (SDZ ETN) is a biosimilar of etanercept (ETN). COMPACT is an ongoing, non-interventional study, evaluating the effectiveness, safety, and quality of life with SDZ ETN treatment in patients (pts) with rheumatoid arthritis (RA), axial-spondyloarthritis (axSpA) or psoriatic arthritis (PsA) in real-world conditions.Objectives:We have reported an interim analysis, with the effectiveness and safety data focusing on pts who were in clinical remission or low disease activity under treatment with reference ETN or biosimilar ETN other than SDZ ETN (initial ETN; iETN) and switched to SDZ ETN.Methods:Pts aged ≥18 years for whom treatment with SDZ ETN were initiated are being enrolled. Pts were categorized under four treatment groups based on prior treatment status: Group A,pts on clinical remission or low disease activity under treatment with iETN and switched to SDZ ETN; Group B, pts who received targeted therapies and switched to SDZ ETN; Group C, biologic naïve considered uncontrolled with conventional therapy; Group D, DMARD naïve with recent diagnosis of RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. Effectiveness assessments included Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) or Ankylosing Spondylitis Disease Activity Score (ASDAS) until Week 24 after enrollment (baseline; BL) in the study. Functional disability was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). The effectiveness and safety results are reported for the pts who switched from iETN (Group A).Results:Of the 1437 pts recruited (analysis cut-off date: 16 Oct, 2020), 567 pts were switched from iETN, 163 were switched from other targeted therapies, 697 were biologic-naïve, and 10 were RA DMARD-naïve. Among pts who switched from iETN, 51.5% had RA, followed by axSpA (28.0%) and PsA (20.5%). Comorbidities were more frequent in pts with RA (70.2%) followed by PsA (58.6%) and axSpA (49.7%); musculoskeletal and connective tissue disorders were reported in 31.8% and 15.7% of pts with RA and axSpA, respectively. At BL, whilst receiving iETN, the mean (SD) DAS28-ESR scores were 2.5 (1.1) and 2.1 (1.1) in pts with RA and PsA, respectively (figure 1). The mean change from BL in DAS28-ESR score at Week 24 after switch to SDZ ETN was -0.1 (1.1) and 0 (1.0) in pts with RA and PsA, respectively. In pts with axSpA, the mean (SD) ASDAS score was 1.5 (0.7) at BL; mean change from BL in ASDAS score at Week 24 was 0.1 (0.5). At BL, the mean (SD) HAQ-DI scores were 0.8 (0.7), 0.5 (0.7) and 0.5 (0.6) in pts with RA, PsA and axSpA, respectively. Overall, the proportion of patients with at least one adverse event (AE) was 37.3%, 33.6% and 25.8% in pts with RA, PsA and axSpA, respectively. Serious AEs were reported in 6.5%, 1.7% and 3.1% of pts with RA, PsA, and axSpA, respectively. Injections site reactions were reported in 2.7%, 0.9% and 1.3% of pts with RA, PsA and axSpA, respectively.Figure 1.Disease activity in patients who switched from iETN to SDZ ETNConclusion:The interim analysis results shows that switch from iETN to SDZ ETN does not impact the effectiveness of ETN in pts with RA, axSpA or PsA, without any new safety signals.Disclosure of Interests:Marc Schmalzing Speakers bureau: Novartis, AbbVie, Chugai/Roche, Janssen-Cilag, Lilly, Consultant of: AstraZeneca, Chugai/Roche, Hexal/Sandoz, Gilead, AbbVie, Janssen-Cilag, Boehringer/Ingelheim, Grant/research support from: Travel grants: Chugai/Roche, Boehringer/Ingelheim, Celgene, Medac, Ayman Askari: None declared, Tom Sheeran Speakers bureau: Pfizer, UCB, Roche, Consultant of: Novartis, Pfizer, Grant/research support from: Novartis, UCB, Roche, David Walsh: None declared, Javier de Toro Santos: None declared, JULIO CESAR VAZQUEZ PEREZ-COLEMAN Speakers bureau: Sandoz, Abbvie, Sanofi, Fresenius, Charlotte Both Employee of: Sandoz employee Global Medical Affairs, Fabricio Furlan Employee of: Sandoz employee Global Medical Affairs, Sohaib HACHAICHI Employee of: Sandoz employee Global Medical Affairs, Herbert Kellner: None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1138.1-1138
Author(s):  
T. Shivacheva ◽  
T. Georgiev ◽  
S. Hristova ◽  
S. Dimitrov ◽  
S. Bogdanova-Petrova ◽  
...  

Background:Sustainability, the ability of drugs to maintain remission or low disease activity (LDA) in patients with rheumatoid arthritis (RA), plays a crucial role for the prevention of structural damage to joints and thus, preserving patients’ functional capacity, health-related quality of life and general sense of well-being. Therefore, studying the sustainable effectiveness of tocilizumab (TCZ) as a monotherapy or combined with methotrexate (MTX) is important (1).Objectives:We aimed to examine to what extend TCZ, alone or combined with MTX, could achieve and further sustain LDA in patients with long-standing RA in the light of current, strictly index-based definitions of LDA and to compare the two versions of DAS28 in patients in real clinical practiceMethods:85 RA patients treated with TCZ for at least eighteen months were consecutively enrolled in the present single-center, retrospective cohort study. All participants met the 1987 ACR classification criteria and attended the rheumatology department of University Hospital “St. Marina” Varna in an outpatient setting. Patients receiving pre-filled syringe contained 162 mg TCZ once weekly subcutaneously. Real-world data were extracted and analyzed from patient’s full medical file. For each visit, disease activity score 28 with ESR and CRP (DAS28-ESR and DAS28-CRP) and simple disease activity index (SDAI) were calculated simultaneously according to generally adopted formulas. A twelve-month result was determined for sustained LDA at each of the patient’s three visits (at 6-month intervals), according to DAS28 and SDAI. Descriptive statistics, Chi square test, Cochran´s Q test, kappa statistic were used, a binary logistics model was compiled to study the impact. Significance level of p <0.05.Results:Two hundred fifty-five patient visits were analyzed. The mean durations of RA and treatment with TCZ were 12.6 (±9.6) years and 3.64 (±1.8) years, respectively. The mean age of patients was 60.3 years (37-87 years), 80% were women, 24.7% were obese, 65.9% have concomitant hypertension. 61.2% of patients are treated with combination therapy TCZ with MTX.Of all patients, these with a sustained 12-month LDA were 41.2%, 28.2% or 23.5% depending on the studied index (DAS28-CRP, SDAI, or DAS28-ESR, respectively).A 12-month SDAI LDA was found in a significantly small proportion of patients (28.2%, p = 0.001). The DAS28 ESR determined a proportion similar to SDAI (23.5%, p> 0.05), while according to the DAS28 CRP, patients with a sustained 12-month LDA were significantly more (41.2% p = 0.005). A moderate level of agreement was found between the assessments of SDAI and the two variants of DAC28 when determining 12-month results of Tocilizumab treatment (DAS28-ESR k = 0.511, p <0.001 and DAC28-CRP k = 0.618, p <0.001). No relationship was found between the combination of TCZ with MTX and the patients’ chance of a sustained 12-month LDA, regardless of which index the result was measured.Patients with hypertension were significantly less likely to have sustained 12-month LDA according to SDAI and DAS 28 ESR (OR 0.135, 95% CI 0.048-0.386; OR 0.313, 95% CI 0.111-0.882, respectively), but not according to DAS28 CRP.Conclusion:Sustained 12- month LDA with TCZ in patients with long-term RA remains uncommon in daily clinical practice. Co-administration of MTX is not associated with an increased likelihood of achieving a sustained LDA in the analysis of long-term responses. Patients with concomitant hypertension are less likely to be in a sustained 12-month LDA, according to SDAI and DAS28-ESR. The results according to DAS28 ESR, but not according to DAS28CRP are comparable to those of SDAI when measuring long-term results of treatment with TCZ.References:[1]Hamann PDH, Pauling JD, McHugh N, Shaddick G, Hyrich K; BSRBR-RA Contributors Group. Predictors, demographics and frequency of sustained remission and low disease activity in anti-tumour necrosis factor-treated rheumatoid arthritis patients. Rheumatology (Oxford). 2019 Dec 1;58(12):2162-2169.Disclosure of Interests:None declared


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1078.1-1079
Author(s):  
I. Yoshii

Background:Patient’s global assessment (PGA) is one important component of Boolean composite criteria for remission in treat with rheumatoid arthritis (RA). However, PGA no more than 10mm is sometimes obstacle to attain clinical remission. In recent few years, one opinion that PGA no more than 20mm may be comparable as no more than 10mm.Objectives:The aim of this study is to analyze how difference of these PGA level affect disease activity and daily activities in living, and evaluate which is optimal for the remission with Boolean remission criteria from real world setting.Methods:RA patients who were followed up for more than three years in the institute were picked up in the study. Each patient was monitored with tenderness joint count (TJC), swollen joint count (SJC), PGA, evaluator’s global assessment (EGA), serum C-reactive protein level (CRP), calculated disease activity score with simplified disease activity index(SDAI), Health Assessment Questionnaire Disability Index (HAQ-DI), and pain score using visual analog scale (PS-VAS) every consulted time from the first encounter (Baseline). Patients were classified according to achievement of Boolean remission criteria. Group 1: a patient group who attained Boolean remission wih TJC≦1, SJC≦1, CRP≦1mg/dl, and PGA≦1 (G-1), Group 2: a patient group who could not attained the Boolean remission used in the G-1 evaluation, but could attained another Boolean remission with TJC≦1, SJC≦1, CRP≦1mg/dl, and PGA≦2 (G-2), and Group 3: a patient group who could not attain Boolean remission for neither criterion.Mean values of measured parameters at Baseline and after the Baseline were compared statistically with Student T-test. Mean values of the same parameters in the G-1 and G-2 at the time of attain Boolean remission for each criteria, mean values of each of these parameters thereafter, and changes of these parameters were compared statistically with Student T-test.Results:A total of 438 patients 385 in the G-1 group, 16 in the G-2 group, and 37 in the G-3 group, were recruited. In parameters at Baseline, level of TJC, SJC, PGA, EGA, SDAI, and HAQ-DI in the G-1 was significantly lower than in the G-3, whereas no significant differences in any parameters demonstrated between in the G-2 and G-3. Level of HAQ-DI, and PS-VAS after Baseline in the G-1 was lower than in the G-3, whereas no significant difference of these parameters after Baseline demonstrated between in the G-2 and G-3. TJC, SJC, PGA, and EGA demonstrated significant less level in the G-1 than in the other two groups. The mean SDAI score at the time of first achievement of Boolean remission in the G-1 and G-2 were 1.08 and 2.57, respectively. The mean value of SDAI score after remission in the G-1 and G-2 were 3.35 and 6.44, respectively. These values and PS-VAS including change of the SDAI score demonstrated significant difference between the two groups (p<0.01), whereas HAQ-DI in the two groups demonstrated no significant difference.Conclusion:These results suggested that setting PGA as no more than 10mm should be reasonable for the evaluation of clinical remission with the Boolean criteria.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 765.2-765
Author(s):  
C. Guillén-Astete ◽  
P. Zurita-Prada ◽  
C. Urrego-Laurín

Background:Synovial inflammation is part of the pathophysiological process of PsoA although it is considered secondary to enthesitis. It is of interest to assess the synovial joint, peritendinous and enthesic response of patients with PsoA in remission under controlled mechanical stress.Objectives:Our aim is to present our observational experience in patients with APso in remission or low activity of the disease exposed to controlled manual physical efforts adapted to the own grasping capacity of each subject.Methods:Before-after study of a consecutive cohort of patients with PsoA (CASPAR criteria), of at least two years d evolution and DAPSA≤14 at present. Patients with positive rheumatoid factor, patients with exclusively axial forms and patients on biological therapy at the beginning of the study were excluded. All patients underwent controlled basal ultrasound and post-dynamometric exercise (CAMRY EH101-17) of the dominant hand which included the carpus, MCFs, IFPs and IFDs of the 2nd to 5th fingers. The ultrasound findings were scored according to EULAR recommendations in grey scale (GS) and power Doppler (PD) for synovitis, enthesitis and tenosynovitis (maximum scores 71 and 87, respectively). For statistical analysis, comparisons were made with the results of their baseline and post-exercise ultrasound scores between subjects diagnosed with PsoA and controls. The Student’s T test was used for related and unrelated data according to correspondence.Results:Nineteen patients and controls were included, of which 73.7% were male. Mean age: 42.2 SD 6.6 and 42.21 SD 8.28, respectively. Basal DAPSA among patients: 7.26 SD 4.53. Mean traction strength of patients and controls: 23.8 SD 7.3 and 26.1 SD 6.9 kg, respectively (P=0.336). In the group of patients, the post exercise DAPSA had a mean of 7.52 SD 4.62 (P=0.021, with respect to the basal DAPSA). The mean total GS score in the patient group was 3.94 SD 2.36 and 7.31 SD 3.3, pre- and post-exercise, respectively (P<0.001). The mean total score in the PD study was 0.73 SD 0.73 and 2.57 SD 1.16, respectively (P<0.001). In patients with PsoA there were no detectable enthesic changes. In the control group, no ultrasound changes were statistically significant, although the score for tenosynovitis ranged from 0.1 SD 0.31 to 0.42 SD 0.6 (P=0.055).Conclusion:Patients with APso in clinical remission or low disease activity develop ultrasound changes after controlled exercise. These changes are appreciable in the joint synovium and tendon but not at an enthesic level. Although these changes are also detectable in a healthy population, their prevalence is much lower. Our interpretation is that control of the disease correlates with an absence of enthesic inflammatory activity although synovial susceptibility remains less evident. This reinforces the idea that PsoA is an inflammatory enthesitis with associated arthritis and not its opposite.Disclosure of Interests:None declared


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1629.2-1629
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  

Background:Axial spondyloarthritis (ax-SpA) is a chronic rheumatic disease that mainly affects men. However, the female form of ax-SpA remains insufficiently studied.Objectives:The aim of this study was to determine the clinical characteristics, the disease activity and the functional impact of female ax-SpA in comparison with male ax-SpA.Methods:This is a retrospective study including patients diagnosed with ax-SpA fulfilling the criteria of the Assessment of SpondyloArthritis international Society (ASAS) 2009.Clinical parameters, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were compared between groups of female and male ax-SpA.Results:Two hundred ax-SpA patients were included with 31% of female (n=62) and a mean age of 43,3 ± 11,2 years.The mean age at onset of symptoms was 31,8 ± 8,9 years for women and 25,3 ± 9,1 years for men (p <0,0001). The mean age at diagnosis was 36,4 ± 9,6 years for women and 31,7 ± 10,4 years for men (p = 0,003). Ax-SpA with juvenile onset was noted in 1,7% of women and 12,1% of men (p = 0,02). Male ax-SpA were significantly more smokers (46.8% vs 5.4%; p <0.001). The mean duration of morning stiffness was 11,3 ± 9,2 minutes for women versus 21,6 ± 19,3 minutes for men (p = 0,005).The mean ESR was 42,4 ± 29,8 mm for women and 28,3 ± 23,4 mm for men (p = 0,001). Radiographic sacroiliitis was present in 69,3% of women versus 84,7% of men (p = 0,01). The use of anti-TNF alpha was less frequent in women (29% vs 48,5%; p = 0,01).Our study didn’t found a statistically significant difference in peripheral manifestations, extraarticular manifestations, CRP, BASDAI and BASFI between the two groups.Conclusion:Female ax-SpA seems to have a better prognosis than male with older age in disease onset, less inflammation, less radiographic sacroiliitis and less use of biological treatments.References:[1]Rusman T, et al. Curr Rheumatol Rep. 2018; 20(6).[2]Siar N, et al. Curr Rheumatol Rev. 2019;Disclosure of Interests:None declared


2021 ◽  
Vol 48 (1) ◽  
Author(s):  
Eman A. Baraka ◽  
Mona G. Balata ◽  
Shereen H. Ahmed ◽  
Afaf F. Khamis ◽  
Enas A. Elattar

Abstract Background This study aimed to measure the serum and synovial interleukin (IL)-37 levels in rheumatoid arthritis (RA) patients compared to patients with primary knee osteoarthritis (PKOA) and healthy controls and to detect its relation to RA disease activity. Results This cross-sectional study included 50 RA patients with a mean age of 40.24 ± 8.62 years, 50 patients with PKOA with a mean age of 56.69 ± 4.21, and 40 healthy controls with a mean age of 41.75 ± 7.38 years. The mean serum IL-37 level in the RA patients (382.6 ± 73.97 pg/ml) was statistically significantly (P < 0.001) the highest among the studied groups; however, it showed a non-significant difference between the PKOA patients (70.38 ± 27.49 pg/ml) and the healthy controls (69.97 ± 25.12 pg/ml) (P > 0.94). Both serum and synovial IL-37 levels were significantly positively correlated with disease activity scores (r = 0.92, P< 0.001 and r = 0.85, P < 0.001), tender joint counts (r = 0.83, P < 0.001 and r = 0.82, P < 0.001 ), swollen joint counts (r = 0.72, P < 0.001 and r = 0.60, P < 0.001), visual analog scale (r = 0.82, P < 0.001 and r = 0.82, P < 0.001), erythrocyte sedimentation rate (r = 0.75, P < 0.001 and r = 0.65, P < 0.001), and C-reactive protein (r = 0.93, P < 0.001 and r = 0.79, P < 0.001), respectively. Conclusion Serum and synovial IL-37 were significantly elevated in the RA patients, and they were closely correlated. Being less invasive, the serum IL-37 could be a marker of disease activity and could reflect the effective disease control by drugs. Having an anti-inflammatory effect could not suggest IL-37 as the key player to control inflammation alone, but its combination with other anti-proinflammatory cytokines could be investigated.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 458.1-458
Author(s):  
R. Yokochi ◽  
H. Tamai ◽  
T. Kido ◽  
Y. Yagyu ◽  
D. Waki ◽  
...  

Background:Several previous observational studies have suggested that patients with anti-Ro/SSA antibody-positive rheumatoid arthritis (RA) may respond poorly to treatment, including tumor necrosis factor inhibitors1. However, its influence on methotrexate (MTX) treatment, which is the anchor drug of treat-to-target strategy in RA treatment, remains unclear.Objectives:We compared the clinical response to MTX in both anti-Ro/SSA antibody-positive and -negative patients with MTX-naiive RA and investigated the reasons for the difference in response.Methods:We recruited 210 consecutive patients with RA who were newly started on MTX in this retrospective cohort study. The effect of the presence of anti-Ro/SSA antibodies on achieving low disease activity (LDA) of DAS28-CRP at six months after initiating MTX was investigated by using logistic regression analysis. CDAI, SDAI, concomitant using DMARDs and painkillers, patient’s and evaluator’s VAS, tender joint counts, and swollen joint counts at six months were also compared between the anti-Ro/SSA-positive patients and -negative patients. Missing data were imputed by using multiple imputations before multivariate analysis.Results:32 anti-Ro/SSA antibody-positive patients and 178 anti-Ro/SSA antibody-negative patients were included. The rate of achieving DAS28-LDA at six months was significantly lower in the anti-Ro/SSA antibody-positive patients than those in the anti-Ro/SSA antibody-negative patients (56.2% versus 75.8%, P=0.03). in the logistic regression analysis, the presence of anti-Ro/SSA antibodies was an independent negative predictor for achieving DAS-28-LDA at six months (OR:0.431, 95%CI: 0.190-0.978, P=0.044) (Table1). Anti-Ro/SSA antibody-positive patients had significantly higher patient’s VAS at six months (median [IQR]: 22 [15-41] vs 19 [5-30], P=0.038), and prescribed NSAIDs (37.5% vs 18.0%, P=0.018). CDAI and SDAI after six months were not significantly different between the group.Conclusion:The presence of anti-Ro/SSA antibodies might be one of the predictive factors for the insufficient response to treat to target strategy in RA treatment. Residual pain was suspected as one of the mechanisms contributing to the lesser clinical response of MTX in anti-Ro antibody-positive RA.References:[1]Ran Matsudaira wt al. J Rheumatol 2011;38(11):2346-54Table 1.Logistic regression analysis for the rate of achieving DAS28 low disease activity at six months.Risk factor Odds ratio95%CIP valueAge at onset0.9930.968-1.0180.586Sex (woman)0.6430.300-1.3840.258RF-positive1.9620.853-4.5110.112ACPA-positive0.5520.225-1.3510.192Anti-Ro/SSA antibody-positive0.4310.190-0.9780.044Disclosure of Interests:None declared


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