scholarly journals OP0298 ARE PATIENTS WITH PSORIATIC ARTHRITIS BEING TREATED OPTIMALLY ACROSS THE WORLD? DISPARITIES IN HEALTH CARE FOR PATIENTS WITH PSORIATIC ARTHRITIS ACROSS COUNTRIES WITH DIFFERENT GDP’S, AN ANALYSIS OF 429 PATIENTS FROM 13 COUNTRIES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 183-183
Author(s):  
F. Lucasson ◽  
U. Kiltz ◽  
J. D. D. Cañete ◽  
A. M. Orbai ◽  
Y. Y. Leung ◽  
...  

Background:In psoriatic arthritis (PsA), EULAR recommendations are to aim for remission or low disease activity(1). Many treatments are now available, though some are costly and not widely available in all countries. Country of patient care, and in particular Gross Domestic Product (GDP) may be linked to PsA outcomes(2). Although patients with high disease activity are eligible for targeted therapies such as biologic disease-modifying anti-rheumatic drugs (bDMARDs), they may not be able to get the benefits from these efficacious treatments in all countries equally.Objectives:The objective was to explore the rate of PsA patients with high to moderate disease activity, not receiving bDMARDs across countries, and to assess the consequences on functional incapacity.Methods:This was a cross-sectional analysis of an observational study (ReFlap, NCT03119805)(3), which included adult patients with PsA with ≥ 2 years disease duration from 14 countries. One country was excluded from this analysis since only 7 patients were included. We explored the rate of patients with significant disease activity (i.e based on DAPSA > 14) and no ongoing bDMARD prescription. Countries of inclusion were analysed separately, and classified into tertiles by GDP/capita (lowest tertile: Brazil, Turkey, Russia, Romania, Estonia; middle tertile: Spain, Italy, UK, France; highest tertile: Canada, Germany, USA and Singapore). The rate of no bDMARDs - DAPSA > 14 patients was analysed by country and compared between the 3 tertiles of GDP/capita by parametric tests. Functional capacity (HAQ) was compared between no bDMARDs - DAPSA > 14 patients and the other patients (pooling patients with moderate or high disease activity with bDMARD, low disease activity and remission with or without bDMARD). There was no imputation of missing data.Results:Of the 459 patients, 429 had complete data available and were analysed: mean age 52.3 (SD 12.6) years, mean disease duration 10.2 (SD 8.2) years, 215 (50.1%) males. The rate of no bDMARDs - DAPSA > 14 patients was 18.4% (76/414). The rate ranged from 7.4% (UK and Spain) to 40% (Russia): Figure 1. A link was seen with the country and the tertiles of countries according to GDP/capita, with higher rate of no bDMARDs - DAPSA > 14 patients in the lowest GDP/capita countries (28.8%, 15.3% and 14.3% in the 3 GDP/capita tertiles, respectively, p=0.005; Figure 1). Of note, 40/76 no bDMARDs - DAPSA > 14 patients received a treatment intensification during the visit. Among no bDMARDs - DAPSA > 14 patients, functional incapacity was higher than in the other patients, as expected (mean HAQ 0.96 (SD 0.64) vs 0.57 (SD 0.63), p<0.001).Figure 1.The size of the bubbles represent the number of patients per country (range, 13 to 89). The horizontal lines represent the mean proportion of patients with no bDMARDs – DAPSA > 14 for each tertiles of countries by GDP/capita.Conclusion:In this exploratory comparison of disease patterns and treatments choices in 13 countries, we observed that more PsA patients with high or moderate disease activity and living in low GDP/capita countries were less likely to be treated with bDMARDs. As a consequence, no bDMARDs – DAPSA > 14 patients had worse functional incapacity. Equitable access to bDMARDs should be aimed for all patients regardless of their country of origin.References:[1]Gossec L et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712.[2]Gossec L et al. Are There Country Differences in Disease Activity and Life Impact of Psoriatic Arthritis? An Analysis of 436 Patients from 14 Countries [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).[3]Gorlier C et al. Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries. Ann Rheum Dis. 2019 Feb;78(2):201-208.Disclosure of Interests:None declared.

Author(s):  
Merve Akdeniz Leblebicier ◽  
Fatıma Yaman ◽  
İsmail Saraçoğlu ◽  
Vural Kavuncu ◽  
Meltem İmal Kızılkaya

Objectives: The aim of this study was to investigate whether shoulder ultrasound (US) findings were associated with disease activity and pain level in rheumatoid arthritis (RA) patients. Patients and methods: Between April 2019 and November 2019, a total of 60 shoulders of 30 female patients with RA (mean age: 53.8±12.0 years; range, 30 to 65 years) were included. The patients were questioned about shoulder pain and their Disease Activity Score-28 (DAS28) was estimated. After clinical examination with shoulder impingement tests, both shoulders were evaluated by US. Results: Of 60 shoulders examined by shoulder US, the most common shoulder pathology was supraspinatus tendinopathy (n=33, 55%). The prevalence of subdeltoid bursitis on US was significantly higher in the group with moderate disease activity, compared to the group with low disease activity (p<0.05). There were no significant differences in the physical examination findings of patients with low and moderate disease activity. In terms of US findings, subscapularis tendinopathy, glenohumeral joint and acromioclavicular joint degeneration, and subacromial bursitis were more common in shoulders with a history of pain, compared to non-painful shoulders. Conclusion: Shoulder US may be useful for demonstrating shoulder involvement in patients with RA, independent of the presence of shoulder pain.


2019 ◽  
Vol 13 (2) ◽  
pp. 80-83
Author(s):  
I. V. Menshikova ◽  
V. V. Strogonova

Objective: to analyze the efficacy of tofacitinib (TOFA) in patients with an advanced stage of rheumatoid arthritis (RA) and previous methotrexate (MTX) failure according to comprehensive clinical and laboratory examination.Patients and methods. Nineteen patients (11 women and 8 men aged 29 to 71 years (mean age 53.47±10.53 years)) with a reliable diagnosis of RA according to the 2012 American College of Rheumatology (ACR) criteria were followed up. Due to a high disease activity (DAS28 averaged 5.84±0.89), the patients were prescribed TOFA 10 mg/day taken for 12 months. The disease activity indicators were assessed at baseline, 3, 6, and 12 months after the start of the study.Results and discussion. The effect of TOFA developed quite quickly: at 3 months of therapy, there were positive clinical, laboratory, and instrumental changes in most patients; 5 (26.3%) patients achieved the goal of treatment. At 12 months of therapy, 8 patients achieved DAS28 remission and 3 patients had a low disease activity; moderate RA activity persisted in 7 patients; and a high disease activity was seen in 1 patient; these SDAI activity indicators were observed in 2, 8, 7, and 2 patients, respectively. According to the ACR criteria, 20, 50, and 70% improvements were achieved by 8, 6, and 3 patients, respectively. No serious adverse reactions were recorded. The findings confirm the good efficacy and safety of TOFA in the treatment of patients with an advanced stage of RA.Conclusion. The innovative mechanism of TOFA allows a significant number of patients, in whom MTX therapy was not effective enough, to achieve the goal of treatment. 


2021 ◽  
Author(s):  
Naoto Tamura ◽  
Takanori Azuma ◽  
Kenta Misaki ◽  
Rei Yamaguchi ◽  
Fuminori Hirano ◽  
...  

Abstract Objectives To evaluate the effectiveness and safety of abatacept over 52 weeks in biologic-naïve rheumatoid arthritis (RA) patients with moderate disease activity in the prospective, 5-year, observational study (ORIGAMI study) in Japan. Methods Abatacept 125 mg was administered subcutaneously once a week. Clinical outcomes included Simplified Disease Activity Index (SDAI) remission at Week 52 (primary endpoint), Japanese Health Assessment Questionnaire (J-HAQ), EuroQol 5-Dimension (EQ-5D), treatment retention, and safety. Results were compared with those of csDMARD controls from the ongoing Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry. Results Overall, 325 patients were enrolled, with a mean age of 66.9±12.7 years. The proportion of patients achieving SDAI remission (≤3.3) at Week 52 was 18.9% (95% CI: 14.3–23.6) and low disease activity (≤11) was 53.3% (95% CI: 47.4–59.1). A significant improvement was observed in J-HAQ and EQ-5D over 52 weeks in both the abatacept and csDMARD groups. The probability of abatacept treatment retention at Week 52 was 69.9% (95% CI: 64.7–75.5). AEs and serious AEs were reported in 50.0% and 12.1% of patients, respectively. Conclusions Abatacept significantly improved disease activity, physical disability, and quality of life for up to 52 weeks in RA patients in a real-world setting.


2020 ◽  
Vol 58 (3) ◽  
pp. 268-275
Author(s):  
E. Yu. Loginova ◽  
Yu. L. Korsakova ◽  
E. E. Gubar ◽  
P. L. Karpova ◽  
T. V. Korotaeva

Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying anti-rheumatic drug (DMARD) tofacitinib (TOFA; Yakvinus®) in patients with active psoriatic arthritis (PsA) at 12 and 24 weeks after starting treatment. To define the place of TOFA in the therapy of PsA patients. Subjects and methods. Examinations were made in 41 patients (17 men and 24 women) with active PsA and an insufficient response to previous treatment with synthetic DMARDs and/or biological agents (BA). Before starting therapy, the median disease activity for psoriatic arthritis (DAPSA) and disease activity score (DAS28) were 44.2 [37.8; 55.3] and 5.5 [4.7; 6.1], respectively. TOFA tablets were prescribed at a dose of 5 mg twice daily for 24 weeks with possible dose escalation to 10 mg twice daily after 12 weeks. At the beginning of the investigation, at 12 and 24 weeks, the investigators assessed disease activity and TOFA therapy efficiency of according to DAPSA, DAS28 and minimal disease activity (MDA) criteria: tender joint count ≤1, swollen joint count ≤1, a psoriasis area severity index (PASI) ≤1 or body surface area (BSA) ≤3%, pain intensity ≤15 mm, patient global assessment ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, and enthesitis ≤1. They also determined the number of patients who had achieved remission (DAPSA ≤4, DAS28 score <2.6), low disease activity (DAPSA 5-14, ≤2.6, DAS28 <3.2) or MDA (5 out of the 7 criteria) during TOFA therapy at 24-week follow-up. The safety of therapy was evaluated by analyzing the drug-induced adverse events (AE): the frequency, severity and time of their occurrence were studied. Results and discussion. At 24 weeks after initiation of TOFA therapy, there was a significant decrease of median DAPSA and DAS28 values as compared to baseline, to 11 [4.3; 17.3] and 2.6 [1.7; 3.4] respectively. The median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) also significantly decreased from 6 [4.2; 7] and 3.8 [2.8; 4.4] to 1.4 [0.6; 3.2] and 1.5 [1; 2.1] respectively. The median BSA was significantly reduced from 3 [1; 5] to 0.5 [0.1; 2]. At 24 weeks after initiation of TOFA therapy, DAPSA and DAS28 low disease activity/remission were achieved by 38.5/23.1% and 17.9/53.9% of patients, respectively. Fifteen (38.5%) patients achieved MDA. 38 (92.7%) of the 41 patients completed a full TOFA therapy cycle. Two patients dropped out of the investigation due to ineffective therapy and one due to AE (diarrhea occurring up to 10 times daily, headache, elevated blood pressure, and lacrimation). At 24 weeks, 14 (34.2%) patients reported to have AE. The most common AE noted in 7 (17.1%) patients were infections: acute respiratory viral infection (n=3), fever (n=2), and folliculitis (n=2). In addition, two patients had diarrhea and two had headache. Conclusion. TOFA is an effective drug for the treatment of PsA patients with moderate or high inflammatory activity, has a significant effect on all clinical manifestations of PsA and has a satisfactory safety profile.


Rheumatology ◽  
2019 ◽  
Vol 59 (1) ◽  
pp. 69-76 ◽  
Author(s):  
Jeanie Z Fei ◽  
Anthony V Perruccio ◽  
Justine Y Ye ◽  
Dafna D Gladman ◽  
Vinod Chandran

Abstract Objectives The Psoriatic Arthritis Disease Activity Score (PASDAS) and Disease Activity Index for Psoriatic Arthritis (DAPSA) are composite PsA disease activity measures. We sought to identify the PASDAS and DAPSA cut-off points consistent with patient acceptable symptom state (PASS), the threshold of symptoms beyond which patients consider themselves well, and examine PASS across published PASDAS and DAPSA thresholds for low, moderate and high disease activity. Methods We used a standard protocol including physician assessment and patient-reported outcomes to prospectively record measures required to calculate PASDAS and DAPSA. We identified PASS thresholds for the PASDAS and DAPSA using receiver operating characteristics curve analyses. We assessed the frequency of reporting acceptable symptom state across disease activity thresholds for PASDAS and DAPSA scores. Results A total of 229 patients (58.5% male, mean age 55.5 years, mean disease duration 17.1 years) were recruited. The PASS threshold for the PASDAS was 3.79 [area under the curve (AUC) 0.86, sensitivity 0.75, specificity 0.82] and for the DAPSA was 11.10 (AUC 0.91, sensitivity 0.89, specificity 0.82). With the PASDAS, 90% of patients defined as having low disease activity considered their symptom state acceptable, compared with 55% and 17% among those with moderate and high disease activity, respectively. With the DAPSA, 98% of patients in disease remission considered their symptom state acceptable compared with 85, 22 and 18% among those with low, moderate and high disease activity, respectively. Conclusion We have defined PASS thresholds for PASDAS and DAPSA. The PASDAS target for low disease activity and DAPSA targets of low disease activity or remission align well with PASS.


2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Priyanka Naranje ◽  
Mahesh Prakash ◽  
Aman Sharma ◽  
Sunil Dogra ◽  
Niranjan Khandelwal

Objective. To determine the frequency of the various ultrasound findings in hand joints in patients with psoriatic arthritis and correlate grayscale and Power Doppler ultrasonography findings with Disease Activity Score 28.Methods. This prospective study was performed in 30 patients. Ultrasound evaluation of 28 joints of both hands was undertaken and various findings were recorded including synovial hypertrophy, Power Doppler abnormality, soft tissue thickening, tendonitis, joint effusion, periosteal reaction, and erosions. Composite ultrasound scores and Disease Activity Score 28 were calculated and compared. Spearman correlation was used to see relationship between the ultrasound and DAS28 scores.Results. Ultrasound detected more abnormalities in the hand joints than did clinical examination. The frequency of various ultrasound abnormalities was as follows: Synovial hypertrophy was seen in 100%, Power Doppler abnormality suggesting hypervascularity was seen in 36.7%, soft tissue thickening was seen in 66.7%, periosteal reaction was seen in 33.3%, erosions were seen in 30% (mostly in DIP and PIP joints), and flexor tendonitis was seen in 6.7% of patients. Significant correlation was found between Disease Activity Score 28 and grayscale joint score (GSJS) (Spearman’sρ: 0.499;P: 0.005), grayscale joint count (GSJC) (ρ: 0.398;P: 0.029), and Power Doppler joint score (PDJS) (ρ: 0.367;P: 0.046). There was a statistically significant difference between remission and low disease activity group and moderate disease activity group in terms of GSJC, GSJS, PDJC, and PDJS (P<0.05). These ultrasound measures were higher in moderate disease activity zone patients.Conclusion. Ultrasound is a useful modality for the objective assessment of psoriatic arthritis. Ultrasound including Power Doppler can be used as a modality for assessment of severity of psoriatic arthritis as it correlates with the clinical scoring.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1637.1-1637
Author(s):  
B. Garcia-Magallon ◽  
M. D. C. Castro Villegas ◽  
R. Rosselló ◽  
V. Navarro-Compán

Background:The Assessment of SpondyloArthritis international Society (ASAS) proposed in 2018 a change in the nomenclature of the Ankylosing Spondylitis Disease Activity Score (ASDAS) for monitoring disease activity in axial spondyloarthritis (axSpA), renaming the previously status of moderate disease activity as low disease activity status, with the presumption that this better reflects the perception that the doctor and the patient have about the disease situation. However, this decision was not data-driven.Objectives:To evaluate the association between the state of low disease activity according to the new ASDAS nomenclature and the therapeutic decision in patients with axSpA.Methods:Longitudinal retrospective study in which patients with axSpA recruited in a secondary hospital were included. All patients with clinical diagnosis of axSpA who started treatment with a first inhibitor of tumor necrosis factor between January 2014 and June 2019 were included. At each follow-up visit, disease activity assessments (including BASDAI and CRP) and the therapeutic decision of the doctor were collected. Later, the ASDAS was calculated and disease status at each visit was classified according to the new nomenclature (inactive, low, high and very high activity). Using descriptive statistics, the association between the disease activity status and the therapeutic decision was evaluated.Results:A total of 304 visits were analyzed in 104 patients with axSpA. Out of these, 57% were women, 47% had a subtype of non-radiographic axSpA and 42% were HLA-B27 positive. The mean (standard deviation) age at diagnosis was 46.9 (12.5) years. In the visits with an ASDAS showing a status of low activity, the therapeutic attitude was not to intensify the treatment in 98.2% of the cases. However, in visits with an ASDAS status of high or very high disease activity, treatment was intensified in 33.7% and 82.8% of cases, respectively.Conclusion:In clinical practice, the status of disease activity initially classified by the ASDAS as moderate disease activity is currently considered to represent low disease activity status based on the therapeutic attitude of following a non-intensification strategy in this situation. These data support the recent change in the nomenclature of disease activity states according to the ASDAS.References:[1]Machado PM, Landewé R, van der Heijde D. Assessment of Spondyloarthritis international Society (ASAS). Ankylosing Spondylitis Disease Activity Score (ASDAS): 2018 update of the nomenclature for disease activity states. Ann Rheum Dis 2018; 77:1539-1540.Figure 1.Association between the state of disease activity according to the new ASDAS nomenclature and the therapeutic decision.Disclosure of Interests:Blanca Garcia-Magallon Consultant of: MSD, Speakers bureau: Pfizer, Amgen, Celgene, MSD, María del Carmen Castro Villegas: None declared, Rosa Rosselló: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB


2020 ◽  
Vol 14 (3) ◽  
pp. 50-56
Author(s):  
T. V. Korotaeva

Objective: to analyze the data available in the literature on the efficacy and safety of ixekizumab (IXE) and adalimumab (ADA) via their direct comparisons in the treatment of psoriatic arthritis (PsA).Patients and methods. The results of the SPIRIT H2H study were analyzed, the aim of which was to investigate the potential superiority of IXE to ADA for arthritis and skin manifestations in a group of patients with active PsA, stable plaque psoriasis with an inadequate response to synthetic disease-modifying antirheumatic drugs (sDMARDs) who had not previously received biological agents (BAs).Design: a 52-week multicenter, randomized, parallel-group study. The patients were randomized 1:1 to open IXE or ADA administration groups for 52 weeks. This review presents the data obtained at 24-week follow-up.Of the 684 screened patients, 566 (82.7%) were included in the study; moreover, the distribution of the patients was equal between the ADA (n=283) and IXE (n=283) groups. At 6 months, 269 (95%) patients in the ADA group and 262 (93%) in the IXE one continued to participate in the study. Efficacy analysis was made based on the achievement of the primary endpoint that was considered to be related to the relative number of patients, who had simultaneously achieved improvements in the joints and skin according to the ACR50 and PASI100 criteria.Results and discussion. At 24 weeks, the proportion of patients who had simultaneously achieved ACR50 and PASI100 responses was significantly higher in the IXE group (36%) than in the ADA one (28%) (p=0.036). It was found that the IXE group was not inferior to the ADA one in terms of ACR50 response rates (in 51% (IXE) and 47% (ADA) patients) and was superior in achieving PASI100 response rates (in 60% (IXE) and 47% (ADA) patients) (p=0.001). The IXE group was recorded to have a higher response than the ADA group and in terms of other manifestations of the disease: the severity of skin and nail psoriasis, enthesitis, remission achievement, minimal and very low disease activity, and improved quality of life. Comparable effectiveness was noted for the effect of the drugs on dactylitis, as well as for the simultaneous achievement of remission and low disease activity in psoriatic arthritis according DAPSA. Serious adverse events (SAEs) were recorded in 8.5% (ADA) and 3.5% (IXE) patients.The safety and tolerability of both BAs corresponded to their previously presented safety profile. The findings were also confirmed at 52-week follow-up, presented at the Meetings of the American College of Rheumatology in November 2019 and the European League Against Rheumatism in June 2020, and published in the leading journals of rheumatology.Conclusion. The first randomized placebo-controlled study (SPIRIT H2H) directly comparing the two BAs with different mechanisms of action demonstrated the advantage of IXE over ADA in simultaneously reducing the activity of arthritis and psoriasis and showed their comparable efficacy comparable efficacy regarding joint symptoms. The use of IXE versus ADA was accompanied by the more frequent achievement of a combined endpoint related to the signs of joint and skin damages in patients with PSA, as well as by the quantitatively lower frequency of SAEs in patients with active PSA who had failed previous sDMARD therapy. The findings are of great importance for clinical practice from the point of view of the reasonable choice of a treatment strategy in these patients.


2018 ◽  
Vol 78 (2) ◽  
pp. 201-208 ◽  
Author(s):  
Clémence Gorlier ◽  
Ana-Maria Orbai ◽  
Déborah Puyraimond-Zemmour ◽  
Laura C Coates ◽  
Uta Kiltz ◽  
...  

BackgroundThe objective was to compare different definitions of remission and low disease activity (LDA) in patients with psoriatic arthritis (PsA), based on both patients’ and physicians’ perspectives.MethodsIn ReFlap (Remission/Flare in PsA; NCT03119805), adults with physician-confirmed PsA and >2 years of disease duration in 14 countries were included. Remission was defined as very low disease activity (VLDA), Disease Activity index for PSoriatic Arthritis (DAPSA) ≤4, and physician-perceived and patient-perceived remission (specific question yes/no), and LDA as minimal disease activity (MDA), DAPSA <14, and physician-perceived and patient-perceived LDA. Frequencies of these definitions, their agreement (prevalence-adjusted kappa), and sensitivity and specificity versus patient-defined status were assessed cross-sectionally.ResultsOf 410 patients, the mean age (SD) was 53.9 (12.5) years, 50.7% were male, disease duration was 11.2 (8.2) years, 56.8% were on biologics, and remission/LDA was frequently attained: respectively, for remission from 12.4% (VLDA) to 36.1% (physician-perceived remission), and for LDA from 25.4% (MDA) to 43.9% (patient-perceived LDA). Thus, patient-perceived remission/LDA was frequent (65.4%). Agreement between patient-perceived remission/LDA and composite scores was moderate to good (kappa range, 0.12–0.65). When patient-perceived remission or LDA status is used as reference, DAPSA-defined remission/LDA and VLDA/MDA had a sensitivity of 73.1% and 51.5%, respectively, and a specificity of 76.8% and 88.0%, respectively. Physician-perceived remission/LDA using a single question was frequent (67.6%) but performed poorly against other definitions.ConclusionIn this unselected population, remission/LDA was frequently attained. VLDA/MDA was a more stringent definition than DAPSA-based remission/LDA. DAPSA-based remission/LDA performed better than VLDA/MDA to detect patient-defined remission or remission/LDA. Further studies of long-term outcomes are needed.


2015 ◽  
Vol 42 (4) ◽  
pp. 599-607 ◽  
Author(s):  
Tsutomu Takeuchi ◽  
Nobuyuki Miyasaka ◽  
Takashi Inui ◽  
Toshiro Yano ◽  
Toru Yoshinari ◽  
...  

Objective.To investigate the probability of clinical remission (REM) or low disease activity (LDA) after 1 year of infliximab (IFX) therapy based on disease activity at 3 months in patients with rheumatoid arthritis (RA).Methods.Methotrexate-refractory patients with RA received 3 mg/kg of IFX at weeks 0, 2, and 6, followed by 3 mg/kg, 6 mg/kg, or 10 mg/kg every 8 weeks from Week 14 (W14) to Week 46. Correlation of disease activity at W14 with disease activity at W54 and probability of REM/LDA at W54 were analyzed in each dosing group.Results.Disease activities at W14 were significantly correlated with both disease activity at W54 and probability of REM/LDA at W54 in patients continuing 3 mg/kg as well as in those receiving 6 mg/kg or 10 mg/kg therapy from W14. Results showed that, if approximate REM or LDA had not been achieved by W14, > 50% of patients continuing 3 mg/kg therapy would not be able to achieve REM or LDA at W54. However, even in patients with high or moderate disease activity at W14, dose escalation to 6 mg/kg or 10 mg/kg enabled many to achieve REM/LDA.Conclusion.Disease activity at W14 in standard-dose IFX therapy enabled the prediction of longterm clinical response at continued standard dose, as well as subsequent escalated-dose regimens. Disease activity at W14 was hypothesized to be an important index for IFX treatment strategy.


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