scholarly journals Effectiveness and drug retention of biologic disease modifying antirheumatic drugs in Korean patients with late onset ankylosing spondylitis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Se Hee Kim ◽  
Hae-Rim Kim ◽  
Sang-Heon Lee ◽  
Kichul Shin ◽  
Hyoun-Ah Kim ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Age Of Onset ◽  
Late Onset ◽  
Retention Rate ◽  
Drug Efficacy ◽  
Retention Rates ◽  
Reactive Protein ◽  
Drug Retention ◽  
Hazard Ratios ◽  
Disease Modifying

AbstractThe clinical data on the biologic disease-modifying antirheumatic drug (bDMARD) use in late-onset ankylosing spondylitis (LOAS) is limited. Thus, this study aimed to evaluate the drug efficacy and retention rate of bDMARDs in LOAS and compare it to young-onset ankylosing spondylitis (YOAS). Data of patients with AS receiving bDMARDs were extracted from the Korean College of Rheumatology Biologics and Targeted Therapy registry. Patients whose age of onset was > 50 years and ≤ 50 years were classified as having LOAS and YOAS, respectively. Their baseline characteristics and disease-associated parameters were evaluated. Drug efficacy [Ankylosing Spondylitis Disease Activity Score (ASDAS)-clinically important improvement (CII), ASDAS-major improvement (MI), Assessment of SpondyloArthritis International Society (ASAS) 20, and ASAS 40] at 1-year follow-up and drug retention rates were assessed. A total of 1708 patients (comprising 1472 patients with YOAS and 236 patients with LOAS) were included in this analysis. The LOAS group had a lower prevalence among males, lower HLA-B27 positivity and a higher prevalence of peripheral arthritis. Patients with LOAS were more likely to have higher disease-associated parameters (inflammatory reactants, patient global assessment, ASDAS-erythrocyte sedimentation rate, and ASDAS-C-reactive protein). LOAS was negatively associated with achieving ASDAS-CII, ASAS 20, and ASAS 40. The drug retention rate was lower in LOAS; however, the propensity score-matched and covariate-adjusted hazard ratios for bDMARD discontinuation were comparable to YOAS. There were no differences in the drug retention rates based on the type of bDMARD used in LOAS. Inferior clinical efficacy and shorter drug retention time were found in patients with LOAS receiving bDMARDs using real-world nationwide data. There were no differences among each bDMARD type.

scholarly journals Effectiveness and drug retention of biologic disease-modifying antirheumatic drugs in Korean patients with late-onset ankylosing spondylitis: Retrospective Cohort Study

2021 ◽  
Author(s):  
Se Hee Kim ◽  
Hae-Rim Kim ◽  
Sang-Heon Lee ◽  
Kichul Shin ◽  
Hyoun-Ah Kim ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Age Of Onset ◽  
Late Onset ◽  
Retention Rate ◽  
Drug Efficacy ◽  
Retention Rates ◽  
Reactive Protein ◽  
Drug Retention ◽  
Hazard Ratios ◽  
Disease Modifying

Abstract Background: The clinical data on the biologic disease-modifying antirheumatic drug (bDMARD) use in late-onset ankylosing spondylitis (LOAS) is limited. Thus, this study aimed to evaluate the drug efficacy and retention rate of bDMARDs in LOAS and compare it to young-onset ankylosing spondylitis (YOAS).Methods: Data of patients with AS receiving bDMARDs were extracted from the Korean College of Rheumatology Biologics and Targeted Therapy registry. Patients whose age of onset was > 50 years and < 50 years were classified as having LOAS and YOAS, respectively. Their baseline characteristics and disease-associated parameters were evaluated. Drug efficacy (Ankylosing Spondylitis Disease Activity Score [ASDAS]-clinically important improvement [CII], ASDAS-major improvement [MI], Assessment of SpondyloArthritis International Society [ASAS] 20, and ASAS 40) at 1-year follow-up and drug retention rates were assessed. Results: A total of 1708 patients (comprising 1472 patients with YOAS and 236 patients with LOAS) were included in this analysis. The LOAS group had a lower prevalence among males, lower HLA-B27 positivity and a higher prevalence of peripheral arthritis. Patients with LOAS were more likely to have higher disease-associated parameters (inflammatory reactants, patient global assessment, ASDAS-erythrocyte sedimentation rate, and ASDAS-C-reactive protein). LOAS was negatively associated with achieving ASDAS-CII, ASAS 20, and ASAS 40. The drug retention rate was lower in LOAS; however, the propensity score-matched and covariate-adjusted hazard ratios for bDMARD discontinuation were comparable to YOAS. There were no differences in the drug retention rates based on the type of bDMARD used in LOAS. Conclusion: Inferior clinical efficacy and drug retention rates were found in patients with LOAS receiving bDMARDs using real-world nationwide data. There were no differences among each bDMARD type.

scholarly journals Comparison of Retention Rates Between Tumor Necrosis Factor-α Inhibitors in Patients With Ankylosing Spondylitis: Data From the Korean College of Rheumatology Biologics Registry

2021 ◽  
Vol 8 ◽  
Author(s):  
Hyoun-Ah Kim ◽  
Sun-Kyung Lee ◽  
Sohee Oh ◽  
Eun Hye Park ◽  
Yong-Beom Park ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Retention Rate ◽  
Retention Rates ◽  
Biologic Agent ◽  
Proportional Hazard ◽  
Korean Patients ◽  
Drug Retention ◽  
Kaplan Meier ◽  
Factor Α

This study aimed to investigate drug retention rates for various TNF inhibitors (TNFis) commonly prescribed to Korean patients with ankylosing spondylitis (AS) in the Korean College of Rheumatology Biologics registry (KOBIO; December 2012–June 2016). Discontinuation was defined as switching or stopping the biologic agent. Kaplan–Meier curves and Cox's proportional hazard models were used for further analysis. The reasons for discontinuation of TNFis were also assessed. Univariate and multivariate analyses were used to identify possible predictors of discontinuation. Data from 1,005 patients with AS were analyzed with a median follow-up period of 14 months. Seventy-six percent of patients were first-line biologic users. Discontinuation of TNFis occurred in 24.2% (switching in 9.6%) of patients during follow-up. An estimate of the drug failure showed that the adjusted hazard ratio (HR) for golimumab compared to etanercept was 0.441 (95% confidence interval: 0.277–0.703, p &lt; 0.001). Reasons for discontinuation included lack of efficacy (32.6%), adverse events (23.6%), clinical improvement (11.2%), and others (32.6%). Predictors of discontinuation using a multivariate analysis were a shorter disease duration (HR: 0.973, p = 0.044) and being negative for HLA-B27 (HR: 1.623, p = 0.0093). In conclusion, few Korean patients with AS switched to other TNFis during their treatment. The drug retention rate for golimumab was higher than for other agents.

Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration

2019 ◽  
Vol 78 (11) ◽  
pp. 1536-1544 ◽  
Author(s):  
Lykke Midtbøll Ørnbjerg ◽  
Cecilie Heegaard Brahe ◽  
Johan Askling ◽  
Adrian Ciurea ◽  
Herman Mann ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Retention Rate ◽  
Response Rates ◽  
Routine Care ◽  
Retention Rates ◽  
Inactive Disease ◽  
Drug Retention ◽  
Asas Criteria

ObjectiveTo study drug retention and response rates in patients with axial spondyloarthritis (axSpA) initiating a first tumour necrosis factor inhibitor (TNFi).MethodsData from 12 European registries, prospectively collected in routine care, were pooled. TNFi retention rates (Kaplan-Meier statistics), Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) were assessed at 6, 12 and 24 months.ResultsA first TNFi was initiated in 24 195 axSpA patients. Heterogeneity of baseline characteristics between registries was observed. Twelve-month retention was 80% (95% CI 79% to 80%), ranging from 71% to 94% across registries. At 6 months, ASDAS Inactive disease/BASDAI<40 rates were 33%/72% (LUNDEX-adjusted: 27%/59%), ASAS 20/40 response rates 64%/49% (LUNDEX-adjusted 52%/40%). In patients initiating first TNFi after 2009, 6097 patients was registered to fulfil ASAS criteria for axSpA, 2935 was registered to fulfil modified New York Criteria for Ankylosing Spondylitis and 1178 patients was registered as having non-radiographic axSpA. In nr-axSpA patients, we observed lower 12-month retention rates (73% (70%–76%)) and lower 6-month LUNDEX adjusted response rates (ASDAS Inactive disease/BASDAI40 20%/50%, ASAS 20/40 45%/33%). For patients initiating first TNFi after 2014, 12-month retention rate, but not 6-month response rate, was numerically higher compared with patients initiating TNFi in 2009–2014.ConclusionA large European database of patients with axSpA initiating a first TNFi treatment in routine care, demonstrated that 27% of patients achieved ASDAS inactive disease after 6 months, while 59% achieved BASDAI <40. Four of five patients continued treatment after 1 year.

scholarly journals AB0466 RETENTION RATE AND EFFECTIVENESS OF SECUKINUMAB VERSUS TNF INHIBITOR SWITCHING IN ANKYLOSING SPONDYLITIS PATIENTS WITH A HISTORY OF TNF INHIBITOR TREATMENT: DATA FROM A KOREAN NATIONWIDE REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1260.1-1260
Author(s):  
H. K. Min ◽  
K. Y. Kang
Keyword(s):  
Ankylosing Spondylitis ◽  
Clinical Efficacy ◽  
Retention Rate ◽  
Drug Discontinuation ◽  
Tnf Inhibitor ◽  
Drug Retention ◽  
Treatment Data ◽  
Adjusted Logistic Regression ◽  
Efficacy Parameters

Background:The choice of second-line biologics for ankylosing spondylitis (AS) patients previously treated with a tumour necrosis factor inhibitor (TNFi) remains unclearObjectives:Here, we compared drug retention and clinical efficacy between AS patients who switched biologics to secukinumab and those who switched to a different TNFi.Methods:AS patients enrolled in the Korean College of Rheumatology BIOlogics registry were included. Patients with previous TNFi exposure were divided into the secukinumab group and the TNFi switching group. Drug retention and clinical efficacy (BASDAI50, ASAS20, ASAS40, ASDAS <2.1, ASDAS clinically important improvement, and ASDAS major improvement) were assessed at the 1 year follow-up. Propensity score (PS)-matched and covariate-adjusted logistic regression analyses were performed.Results:246 had available 1 year follow-up data. Secukinumab as third- or later-line biologics was more frequent than alternative TNFi (54% vs. 14%). PS-matched and multiple covariate-adjusted analyses showed that the odds ratio (OR) for drug discontinuation was comparable between the secukinumab and TNFi switching groups (OR=1.136; 95% CI, 0.843–1.531 and OR=1.000; 95% CI, 0.433–2.308, respectively). The proportion of patients who achieved BASDAI50 was also comparable between the two groups (OR=0.833; 95% CI, 0.481–1.441 in PS-matched analysis). Other clinical efficacy parameters were also comparable. In the subgroup analysis of AS patients with previous TNFi discontinuation due to ineffectiveness, all clinical efficacy parameters were comparable between the two groups.Conclusion:In AS patients with previous exposure to a TNFi, switching biologics to secukinumab and switching to an alternative TNFi resulted in comparable drug retention and clinical efficacy.References:[1]Micheroli R, Tellenbach C, Scherer A, et al. Effectiveness of secukinumab versus an alternative TNF inhibitor in patients with axial spondyloarthritis previously exposed to TNF inhibitors in the Swiss Clinical Quality Management cohort. Ann Rheum Dis 2020;79:1203-9.Disclosure of Interests:None declared.

scholarly journals AB0252 EFFICACY OF A SECOND JANUS KINASE INHIBITOR THAT WAS SWITCHED FOR DIFFICULT-TO-TREAT RA IN CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1151.2-1152
Author(s):  
M. Kamiya ◽  
D. Togawa ◽  
S. Mori ◽  
K. Yamazaki
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Retention Rate ◽  
Janus Kinase ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Drug Retention ◽  
Disease Modifying ◽  
Necrosis Factor ◽  
Drug Retention Rate

Background:In clinical practice, when refractory rheumatoid arthritis (RA) is present, of which the definition implies previous use of at least two biologic disease-modifying antirheumatic drugs (bDMARDs) (generally tumour necrosis factor inhibitors (TNFis)), the next treatment choice often made is a bDMARD of another class (non-TNFis) [1]. However, patients who are inadequately responding to bDMARDs need new treatment options because subsequent bDMARDs treatment reduces their response [2]. Janus Kinase inhibitors (JAKis) are the first targeted synthetic DMARDs (tsDMARD) licensed for the treatment of RA with comparable efficacy to bDMARDs. Unlike the single cytokine targeting approach of bDMARDs, JAKis are specifically designed to inhibit intracellular signalling molecules common to the receptors of multiple inflammatory cytokines implicated in RA pathogenesis. The choice of therapeutic agents for refractory RA is increasing, and its efficacy is expected. On the other hand, it is also true that some patients discontinued JAKis at a rate that cannot be overlooked because of insufficient efficacy. Difficult-to-treat (D2T) RA is defined as refractory to two or more b/ts DMARDs with different mechanisms of action, with active and progressive disease, as published by Eular(3)Objectives:To evaluate real world efficacy of approved JAKis switching in patients with D2T RA who were unable to control their disease activity due to insufficient efficacy despite the sequential use of multiple bDMARDs and JAKis, focusing on the drug retention rate.Methods:In our hospital, RA was diagnosed according to the 1987 or 2010 classification criteria, and when two or more bDMARDs (including both TNFis and non-TNFis) were inadequately effective, it was defined as D2T RA. We retrospectively investigated patients who switched to JAKis for D2T RA. The drug retention rate was investigated by the Kaplan-Meier method, and the difference was tested by the Logrank test.Results:The 1-year retention rate of JAKis for D2T RA was 50.8% in TOF 38 cases [28 women, age average 70.2 years, disease duration average 12.4 years, past bDMARDs use average 3.5 drugs, MTX combination 9 cases, DAS28 ESR average 4.11] and 66.3% in BAR 35 cases [26 cases, 73.0 years old, 14.8 years, 4.17 agents, 9 cases, 3.68], and there was no significant difference (P = 0.30). Among them, there were 17 cases [11 cases, 70.6 years old, 13.5 years, 4.18 drugs, 2 cases, 3.65] of switching between JAKis, all of which were switching from TOF to BAR. The 1-year retention rate was 45.8% [reason for discontinuation: insufficient effect in 3 cases, adverse events in 6 cases], which was not significantly different but tended to be lower than 72.7% [reason for discontinuation: insufficient effect in 1 case, adverse event in 2 cases, patient’s convenience in 1 case] in 16 patients [13 cases, 76.3 years old, 17.1 years, 3.19 drugs, 7 cases, 3.69] who received BAR as the first JAKi for D2T RA patients (P = 0.089).Conclusion:Although the number of cases is small in the retrospective survey, it is suggested that the retention rate of BAR switched to D2T RA may be slightly lower in patients with a history of TOF discontinuation due to insufficient efficacy than in JAKi naive patients. It is expected that the number of new JAKi usage cases will increase in the future, and it is necessary to consider switching between other JAKis in addition to switching from BAR to TOF.References:[1]Smolen JS, Landewe R, Bijlsma J et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017;76:960_77.[2]Rendas-Baum R, Wallenstein GV, Koncz T et al. Evaluating the efficacy of sequential biologic therapies for rheumatoid arthritis patients with an inadequate response to tumor necrosis factor-α inhibitors. Arthritis Res Ther 2011;13:R25.[3]Nagy G, et al. EULAR definition of difficult-to-treat rheumatoid arthritis. Ann Rheum Dis 2021;80:31–35. doi:10.1136/annrheumdis-2020-217344.Disclosure of Interests:None declared

scholarly journals Differential long-term retention of biological disease-modifying antirheumatic drugs in patients with rheumatoid arthritis by age group: an observational study

2020 ◽  
Author(s):  
Akio Kawabe ◽  
Kazuhisa Nakano ◽  
Satoshi Kubo ◽  
Takeshi Asakawa ◽  
Yoshiya Tanaka
Keyword(s):  
Rheumatoid Arthritis ◽  
Propensity Scores ◽  
Retention Rate ◽  
Age Groups ◽  
Therapeutic Strategies ◽  
Retention Rates ◽  
Age Group ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Disease Modifying

Abstract Background. The effectiveness and safety of biological disease-modifying antirheumatic drugs (bDMARDs) by age group (<65, 65–74, and ≥75 years) are uncertain. We examined retention rates reflecting the effectiveness and safety of bDMARDs in actual clinical practice for clarifying optimal therapeutic strategies for rheumatoid arthritis (RA) by age groups.Methods. Data of patients who were treated with tumor necrosis factor inhibitors (TNFi), abatacept (ABA), and tocilizumab (TCZ) between February 2011 and April 2017 were retrospectively collected from an observational registry of RA patients. A total of 1,362 patients were enrolled, of which 695 were aged <65 years, 402 were aged 65–74 years, and 265 were aged ≥75. Primary outcome was the drug retention rate in adjusted data using inverse probability of treatment weighting based on generalized propensity scores.Results. In patients aged <65 years, three-year retention rates of TNFi, ABA, and TCZ were 43%, 47%, and 69%, respectively (ABA versus TCZ, p = 0.017; TNFi versus TCZ, p = 0.002). In patients aged 65–74 years, three-year retention rates of TNFi, ABA, and TCZ were 44%, 53%, and 60%, respectively (TCZ versus TNFi, p = 0.034). In patients aged ≥75 years, three-year retention rates for TNFi, ABA, and TCZ were 38%, 63%, and 58%, respectively (ABA versus TNFi, p = 0.017).Conclusions. We found that the effectiveness and safety of TCZ were maximized in patients aged <75 years and that patients aged ≥65 years were the most suited candidates for ABA therapy. The use of therapeutic strategies appropriate to each age group might improve the outcomes of bDMARD therapy for RA.

scholarly journals Assessing disease severity by hsCRP as a biochemical marker for psoriasis

2017 ◽  
Vol 3 (4) ◽  
pp. 501
Author(s):  
Kriti Jain ◽  
Arvind Krishna ◽  
B. S. Rathore
Keyword(s):  
Disease Severity ◽  
Age Of Onset ◽  
Late Onset ◽  
Severe Disease ◽  
High Sensitivity ◽  
The Body ◽  
Clinical Severity ◽  
Positive Correlation ◽  
Reactive Protein ◽  
Pasi Score

<p class="abstract"><strong>Background:</strong> <span lang="EN-IN">For a complex chronic disease like psoriasis, having a biomarker to objectively assess the clinical severity can be very helpful in disease management.</span></p><p class="abstract"><strong>Methods:</strong> <span lang="EN-IN">In a hospital based prospective study, 70 patients of psoriasis diagnosed clinically, were studied. The extent of disease severity was assessed using PASI and BSA and patients were grouped into having mild, moderate and severe disease using these scores. Serum high sensitivity </span>C-reactive protein <span lang="EN-IN">(hsCRP) levels were then estimated for each group</span>.<strong></strong></p><p class="abstract"><strong>Results:</strong> <span lang="EN-IN">Of the 70 psoriasis cases enrolled, 46 patients were male and 24 females. Patients with early onset psoriasis were associated with higher values of hsCRP than those with late onset (r=-0.063; p=0.012). A positive correlation was seen between the PASI score and hsCRP levels (r=0.891; p≤0.001). On comparing mean PASI and mean hsCRP in severity groups (mild, moderate and severe), hsCRP was higher in the group with maximum severity (p≤0.001). </span></p><p class="abstract"><strong>Conclusions:</strong> <span lang="EN-IN">A negative correlation between the age of onset and hsCRP implies that, earlier the age of onset, higher is the value of hsCRP. Our study shows a positive correlation between the body surface area and PASI score both of which varied linearly with hsCRP values. The findings also suggest that patients with severe psoriasis have higher mean serum hsCRP levels than patients with mild psoriasiss.</span><span lang="EN-IN">We proposed hsCRP as a useful marker of psoriasis severity that could be used to monitor psoriasis and, together with PASI, as a global index of disease severity.</span></p><p class="abstract"> </p>

scholarly journals The Effectiveness and Retention Rate of Iguratimod in Japanese Rheumatoid Arthritis Patients with/without Methotrexate in Daily Medical Care

Life ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. 261
Author(s):  
Asuka Inoue ◽  
Yuji Nozaki ◽  
Yasuaki Hirooka ◽  
Koji Kinoshita ◽  
Yasutaka Chiba ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Clinical Response ◽  
Disease Activity Score ◽  
Retention Rate ◽  
Retention Rates ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Secondary Endpoints

(1) Background: We evaluated the clinical response of iguratimod (IGU) in patients with rheumatoid arthritis (RA) being treated with or without methotrexate (MTX) over 54 weeks. (2) Methods: 106 patients with RA undergoing IGU were retrospectively observed. RA patients were divided into those treated with MTX+IGU (n = 35) and those treated with IGU (n = 71). The primary endpoint was the clinical response of the Disease Activity Score assessing 28 joints with C-reactive protein (DAS28-CRP) differences in the changes from baseline to 54 weeks between MTX+IGU and IGU groups. Secondary endpoints, such as the clinical response, retention rate, and safety, were evaluated. (3) Results: The DAS28-CRP difference in the changes between the two groups were −0.2. DAS28-CRP were significantly reduced from the baseline in the MTX+IGU and IGU groups (−1.43 and −1.20 from baseline, respectively). The retention rates were 71.4% in the MTX+IGU groups and 59.2% in the IGU groups (p = 0.16). Adverse events were observed in a total of 6 (17.1%) MTX+IGU patients and 20 (28.2%) IGU patients (p = 0.21). (4) Conclusions: IGU therapy may be a useful treatment option for patients who cannot be treated with MTX.

scholarly journals Long-Term Effectiveness of Secukinumab in Patients with Axial Spondyloarthritis

2020 ◽  
Vol 2020 ◽  
pp. 1-5 ◽  
Author(s):  
Stefano Gentileschi ◽  
Donato Rigante ◽  
Jurgen Sota ◽  
Giuseppe Lopalco ◽  
Maria Grazia Giannotta ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Retention Rate ◽  
Statistical Significance ◽  
Laboratory Assessment ◽  
Biologic Treatment ◽  
Drug Retention ◽  
Drug Retention Rate

Objectives. The primary aim of our study was to evaluate long-term efficacy of secukinumab (SCK) in patients with axial spondyloarthritis (axSpA); secondary aims were to evaluate drug retention rate and to identify differences in the clinical and laboratory assessment according to axSpA clinical features, dosage administered, and biologic treatment lines. Patients and Methods. We collected clinical, demographical, and treatment data from 39 patients affected by axSpA consecutively treated with SCK. Laboratory assessment was based on inflammation parameters; clinical assessment was performed with the Ankylosing Spondylitis Disease Activity Score- (ASDAS-) CRP and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Data were recorded at baseline and every 3 months for the first year and then every 6 months in the second year. Results. Twelve males and 27 females were enrolled; both BASDAI and ASDAS-CRP showed a statistically significant reduction during the observation period (p<0.0001 and p<0.0001, respectively). C-reactive protein significantly decreased (p=0.006), with significant reduction at the post hoc analysis between baseline and both 6-month evaluation (p=0.02) and 24-month visit (p=0.036). No statistical significance was observed in BASDAI and ASDAS-CRP improvement (p=0.482 and p=0.164, respectively) between different dosages administered. No significant differences emerged in the BASDAI and ASDAS-CRP variations between biologic-naïve patients and subjects previously failing to tumour necrosis factor (TNF) inhibitors (p=0.53 and p=0.148, respectively). At the end of our observation, 7 out of 39 patients discontinued SCK. The global retention rate at the end of the study period was 78.2%, without any significant differences between biologic-naïve and anti-TNF-failure patients (p=0.619) or between subjects administered with different SCK dosages (p=0.614). No adverse events were reported. Conclusions. In our cohort, SCK has proved a remarkable effectiveness regardless biologic treatment line and dosages employed. As suggested by the notable drug retention rate, SCK has been able to maintain its effectiveness over a considerable long period of treatment.

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