scholarly journals Ideal target for psoriatic arthritis? Comparison of remission and low disease activity states in a real-life cohort

2017 ◽  
Vol 77 (2) ◽  
pp. 251-257 ◽  
Author(s):  
Leonieke J J van Mens ◽  
Marleen G H van de Sande ◽  
Arno W R van Kuijk ◽  
Dominique Baeten ◽  
Laura C Coates
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Skin Disease ◽  
Residual Disease ◽  
Negative Impact ◽  
Activity Index ◽  
Real Life ◽  
Added Value ◽  
Tender Joint Count ◽  
Low Disease Activity

BackgroundPsoriatic arthritis (PsA) recommendations state that the target of treatment should be remission or low disease activity (LDA). We used a real-life dataset to compare different potential targets.Methods250 patients with PsA considered in an acceptable disease state according to their rheumatologist were included. Targets for remission were the Disease Activity Index for Psoriatic Arthritis (DAPSA) and clinical DAPSA (cDAPSA) remission (≤4), very low disease activity (VLDA) and Psoriatic Arthritis Disease Activity Score ≤1.9. LDA targets analysed were the DAPSA ≤14, cDAPSA ≤13, minimal disease activity (MDA) and adjusted MDA targets: MDAjoints with both tender joint count (TJC) and swollen joint count (SJC) mandated, MDAskin (psoriasis area and severity index (PASI) mandated) and MDAjoints&skin with TJC, SJC and PASI mandated.ResultsComparison of the several candidate targets demonstrates that VLDA is achieved by the lowest proportion of patients and includes patients with the lowest residual disease activity compared with the other remission targets. The modified MDA measures are the most stringent targets for LDA in terms of residual disease on joints, psoriasis and enthesitis within patients achieving the target. In both remission and LDA, the inclusion of C reactive protein did not show an added value. The exclusion of a skin domain, as in the DAPSA measures, resulted in negligence of skin disease and a negative impact on the quality of life in some patients.ConclusionsThe different remission and LDA targets show us significant overlap between measures, but these measures targeting the same definition do differ in terms of allowance of residual disease. Inclusion of laboratory markers seems unnecessary, although exclusion of a skin domain may result in psoriasis not being assessed resulting in residual impactful skin disease.

scholarly journals Comparison of Different Remission and Low Disease Definitions in Psoriatic Arthritis and Evaluation of Their Prognostic Value

2018 ◽  
Vol 46 (2) ◽  
pp. 160-165 ◽  
Author(s):  
Laura C. Coates ◽  
Alice B. Gottlieb ◽  
Joseph F. Merola ◽  
Caroline Boone ◽  
Annette Szumski ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Residual Disease ◽  
Activity Index ◽  
Skin Lesions ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Clinical Trial Registration ◽  
Low Disease Activity ◽  
Link Type

Objective.There is no agreement on the optimal definitions for assessing disease state in patients with psoriatic arthritis (PsA), and some of the commonly used definitions do not include assessment of skin lesions. We investigated the performance of various definitions in patients with PsA and psoriasis.Methods.This was a posthoc analysis of data from the PRESTA study. The remission definitions analyzed were very low disease activity (VLDA) index, defined as 7/7 of the minimal disease activity (MDA) cutoffs; Disease Activity Index for PsA (DAPSA); and clinical (c-) DAPSA. The low disease activity (LDA) definitions analyzed were as follows: MDA defined as 5/7 cutoffs; MDA joint with both the tender joint count (TJC) and swollen joint count (SJC) cutoffs mandated; MDA skin where skin cutoff was mandated; MDA joint + skin where TJC, SJC, and skin cutoffs were mandated; DAPSA LDA; and cDAPSA LDA.Results.At Week 24, the proportions of patients achieving VLDA, DAPSA, and cDAPSA remission were 10%, 35%, and 37%, respectively. Of the patients achieving DAPSA and cDAPSA remission, 55% and 56%, respectively, had Psoriasis Area and Severity Index > 1. The proportions of patients achieving MDA 5/7, MDA skin, MDA joint, and MDA joint + skin were 44%, 19%, 36%, and 14%, respectively, versus 70% achieving DAPSA and cDAPSA LDA. Notable residual levels of psoriasis were observed in patients achieving the definitions that did not require skin disease control.Conclusion.VLDA and MDA definitions are more stringent than DAPSA and cDAPSA definitions for the assessment of PsA. The relevance of residual disease to patients, however, remains to be determined. [Clinical Trial registration:ClinicalTrials.govNCT00245960]

scholarly journals Residual Disease Activity and Associated Factors in Psoriatic Arthritis

2019 ◽  
Vol 47 (10) ◽  
pp. 1490-1495 ◽  
Author(s):  
Ennio Lubrano ◽  
Silvia Scriffignano ◽  
Fabio Massimo Perrotta
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Associated Factors ◽  
Residual Disease ◽  
Activity Index ◽  
Composite Index ◽  
Disease Activity Index ◽  
Psoriasis Area Severity Index ◽  
Low Disease Activity ◽  
Patient Reported

ObjectiveRemission or low disease activity should be the treatment target of psoriatic arthritis (PsA). However, residual disease activity (RDA) in some domains could persist. The aim of this study was to assess RDA and its associated factors in a group of patients with PsA.MethodsPatients with PsA were enrolled if they satisfied ClASsification for Psoriatic ARthritis (CASPAR) criteria with > 6 months’ followup and achieved a status of low disease activity (LDA), minimal disease activity (MDA), or remission [Disease Activity Index for PsA (DAPSA) remission or very low disease activity (VLDA)]. RDA was assessed by the percentage of patients who had, although in LDA or remission, tender and/or swollen joints > 1, Leeds Enthesitis Index > 1, Health Assessment Questionnaire > 0.5, Psoriasis Area Severity Index (PASI) > 1, patient’s global assessment > 20, physician visual analog scale (VAS) > 20, and VAS pain > 15. Associated factors of RDA were also assessed.ResultsOf 113 enrolled patients, 78 (69%) were in MDA. Moreover, DAPSA remission was observed in 46 (40.7%) while VLDA only in 32 (28.3%) of patients with PsA. VLDA seems to be the most stringent criterion, with a minimal RDA only in the VAS physician in 1 patient (3.1%) and none in the different domains, while patients in MDA had RDA in tender joints (14.1%), VAS pain (29.4%) and PASI > 1 or body surface area (BSA) > 3% (17.9%). Of note, although patients in DAPSA remission show a very low rate of RDA in almost all domains, 12 (26%) of them show a PASI > 1 or BSA > 3%. Finally, LDA shows RDA in higher percentages, mainly in patient-reported outcomes, tender joints, and skin domain.ConclusionRDA can be recognized in patients with PsA. VLDA seems to be the most stringent composite index to identify patients in the absence of RDA.

scholarly journals Residual disease burden in axial Spondyloarthritis and Psoriatic Arthritis patients despite low disease activity states in a multi-ethnic Asian population

2020 ◽  
pp. jrheum.200934
Author(s):  
Venice Liu ◽  
Warren Fong ◽  
Yu Heng Kwan ◽  
Ying-Ying Leung
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Axial Spondyloarthritis ◽  
Residual Disease ◽  
Activity Index ◽  
Well Being ◽  
Functional Health ◽  
Mental Wellbeing ◽  
Low Disease Activity ◽  
Pain Scores

Objective To evaluate the burden of residual disease in patients with axial SpondyloArthritis (axSpA) or Psoriatic Arthritis (PsA) who achieved low disease activity status. Methods We used baseline data from a clinic registry of SpA in a tertiary hospital in Singapore. For axSpA, LDA was defined as ASDAS-ESR <2.1 or BASDAI <3/10. For PsA, LDA was defined by achieving 5/7 cut-offs in the Minimal Disease Activity (MDA) or clinical Disease Activity index for Psoriatic Arthritis (cDAPSA) ≤13. Results From 262 cases of axSpA (21% women; mean ± standard deviation (SD) age 42 ± 14 years), 33% and 43% of patients achieved ASDAS-ESR and BASDAI LDA states respectively. While from 142 cases of PsA (49% women; mean ± SD age 51 ± 14 years), 35% and 63% achieved MDA and cDAPSA LDA, respectively. Both axSpA and PsA patients with LDA had pain scores range from 14.0 to 21.4/100 and fatigue scores from 3.1 to 3.6/10. Substantial burden in physical disability and mental wellbeing were observed with low physical and mental component summary of SF-36. AxSpa patients in BASDAI LDA had higher ESR and lower disability than those in ASDAS-ESR LDA. cDAPSA classified nearly twice as many PsA patients into LDA than MDA. Compared to PsA patients in MDA LDA, PsA patients in cDAPSA LDA had higher active joint counts, dactylitis, enthesitis, pain scores and patient global assessment (PtGA) Conclusion Despite being in LDA, patients with axSpA and PsA experienced substantial residual burden in pain, fatigue, poorer functional health and mental well-being.

scholarly journals Methotrexate achieves major cDAPSA response, and improvement in dactylitis and functional status in psoriatic arthritis

Rheumatology ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 869-873 ◽  
Author(s):  
Sravan Kumar Appani ◽  
Phani Kumar Devarasetti ◽  
Rajendra Vara Prasad Irlapati ◽  
Liza Rajasekhar
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Response To Therapy ◽  
Tender Joint Count ◽  
Minimal Disease Activity ◽  
Randomized Controlled Studies ◽  
Minimal Disease

Abstract Objective Despite the widespread clinical use of MTX in PsA, data from published randomized controlled studies suggest limited efficacy. The objective of the present study was to document the efficacy of MTX. Methods This was an open-label, prospective study of patients satisfying the ClASsification criteria for Psoriatic ARthritis study (CASPAR) criteria for PsA who received MTX in doses of ⩾15 mg/week throughout the follow-up period of 9 months. Disease activity was assessed across various domains by tender and swollen joint count, physician and patient global assessment, DAS-28 ESR, Clinical Disease Activity Index for PsA (cDAPSA), Leeds Dactylitis Instrument basic, Leeds Enthesitis Index (LEI), Psoriasis Area and Severity Index (PASI), Minimal Disease Activity and HAQ (CRD Pune version) at baseline and at 3, 6 and 9 months of follow-up. Response to therapy was assessed by EULAR DAS28 ESR, Disease Activity Index for PsA (cDAPSA) response, HAQ response and PASI75. MTX dose escalation and the use of combination DMARDS were dictated by disease activity. Results A total of 73 patients were included, with mean (s.d.) age 44 (9.7) years. The mean (s.d.) dose of MTX used was 17.5 (3.8) mg/week. Seven patients received additional DMARDS (LEF/SSZ). At the end of 9 months, significant improvement (P < 0.05) was noted in the tender joint count, swollen joint count, global activity, DAS-28ESR, cDAPSA, Leeds Dactylitis Index basic, LEI, PASI and HAQ. Major cDAPSA response was achieved in 58.9% of patients. EULAR DAS28 moderate and good response was achieved in 74% and 6.8% of patients, respectively. Minimal Disease Activity was achieved in 63% of patients. A PASI75 response and HAQ response was achieved in 67.9% and 65.8% of patients, respectively. Conclusion MTX initiated at ⩾15 mg/week with targeted escalation resulted in significant improvement in the skin, joint, dactylitis, enthesitis and functional domains of PsA.

scholarly journals Remission and low disease activity in psoriatic arthritis publications: a systematic literature review with meta-analysis

Rheumatology ◽  
2020 ◽  
Vol 59 (8) ◽  
pp. 1818-1825 ◽  
Author(s):  
Benjamin Hagège ◽  
Elina Tan ◽  
Martine Gayraud ◽  
Bruno Fautrel ◽  
Laure Gossec ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Disease Activity ◽  
Systematic Literature Review ◽  
Activity Index ◽  
Meta Analysis ◽  
Random Effect ◽  
Disease Activity Index ◽  
Low Disease Activity ◽  
Pooled Prevalence

Abstract Objectives Remission (REM) or low disease activity (LDA) is the treatment target in psoriatic arthritis (PsA). The objective of this study was to assess the reporting and prevalence of REM/LDA in published studies of PsA. Methods This was a systematic literature review of all clinical papers published in PubMed, EMBASE or Cochrane database in English between 2012 and 2019 in the field of PsA. Data were collected regarding reporting of REM/LDA by very low disease activity/minimal disease activity (VLDA/MDA), Disease Activity index for Psoriatic Arthritis (DAPSA), or Disease Activity Score 28 joints (DAS28). The pooled rates of REM and LDA by each definition were calculated by random effect meta-analysis. Results In all, 258 publications (corresponding to 114 651 patients), of which 81 (31%) were randomized controlled trials, were analysed: patients’ mean age was 49.4 ( 4.4) years; with a mean disease duration of 8.5 ( 3.8) years. REM/LDA was reported in 91/258 (35.3%) publications. VLDA/MDA was used in 61/91 (67.0%) studies, DAPSA in 27/91 (29.6%) and DAS28 in 28/91 (30.7%), with 40/91 (43.9%) papers reporting several of these definitions. The pooled prevalence (lower–upper limits) of REM was 13.1% (10.9–15.4), 23.1% (16.8–30.1) and 42.1% (33.9–50.4) using VLDA, DAPSA-REM and DAS28, respectively. For LDA the pooled prevalence was 36.3% (32.3–40.5), 52.8% (41.8–63.6) and 60.4% (52.5–68.0) using MDA, DAPSA-LDA and DAS28, respectively. Conclusion REM/LDA status was reported in only1/3 of recent studies on PsA, with important variations in the frequency of these outcomes according to the definition used: 13.1–42.1% for REM, and 36.3–60.4% for LDA. This highlights the need for consensus.

Need for Improvement in Current Treatment of Psoriatic Arthritis: Study of an Outpatient Clinic Population

2017 ◽  
Vol 44 (4) ◽  
pp. 431-436 ◽  
Author(s):  
Brigitte Michelsen ◽  
Andreas P. Diamantopoulos ◽  
Hege Kilander Høiberg ◽  
Dag Magnar Soldal ◽  
Arthur Kavanaugh ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Activity Index ◽  
Real Life ◽  
Disease Activity Index ◽  
Activity Score ◽  
Psoriatic Skin ◽  
Biologic Treatment ◽  
Remission Criteria

Objective.To explore the burden of skin, joint, and entheses manifestations in a representative psoriatic arthritis (PsA) outpatient cohort in the biologic treatment era.Methods.This was a cross-sectional study of 141 PsA outpatients fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria and examined between January 2013 and May 2014. Selected disease activity measures were explored including Disease Activity index for PSoriatic Arthritis (DAPSA), Composite Psoriatic Disease Activity Index (CPDAI), Psoriatic Arthritis Disease Activity Score (PASDAS), Disease Activity Score for 28 joints (DAS28), Simplified Disease Activity Index (SDAI), and Psoriasis Area Severity Index (PASI). Dermatology Life Quality Index (DLQI), minimal disease activity (MDA), and remission criteria were assessed.Results.Median (range) DAPSA was 14.5 (0.1–76.4), CPDAI 5 (1–11), PASDAS 3.1 (2.1–4.2), DAS28-erythrocyte sedimentation rate (ESR) 3.2 (0.6–6.4), SDAI 8.6 (0.1–39.5), PASI 1.2 (0.0–19.7), and DLQI 2.0 (0–17). The MDA criteria were fulfilled by 22.9% of the patients. DAPSA ≤ 4, CPDAI ≤ 2, PASDAS < 2.4, DAS28-ESR < 2.4, SDAI < 3.3, and Boolean’s remission criteria were fulfilled by 12.1, 9.3, 7.8, 26.2, 21.3, and 5.7% of patients, respectively. The number of satisfied patients was similar regardless of whether the group was treated with tumor necrosis factor inhibitors.Conclusion.Our real-life data indicate that there is still a need for improvement in today’s treatment of PsA. Musculoskeletal inflammatory involvement was more prominent than psoriatic skin involvement. Only a few patients fulfilled the DAPSA, PASDAS, and CPDAI remission criteria, and about a quarter fulfilled the MDA criteria. Considerably fewer patients fulfilled PsA-specific remission criteria versus non-PsA specific remission criteria. Still, patient satisfaction was good and PASI and DLQI were low.

Defining Low Disease Activity States in Psoriatic Arthritis using Novel Composite Disease Instruments

2015 ◽  
Vol 43 (2) ◽  
pp. 371-375 ◽  
Author(s):  
Laura C. Coates ◽  
Philip S. Helliwell
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Activity Index ◽  
Disease Activity Index ◽  
Substantial Agreement ◽  
Good Discrimination ◽  
Low Disease Activity ◽  
Minimal Disease ◽  
The Relationship

Objective.To explore the relationship between minimal disease activity (MDA) and the low disease activity cutoffs of the Psoriatic ArthritiS Disease Activity Score (PASDAS) and the Composite Psoriatic Disease Activity Index (CPDAI).Methods.Data from the GRAPPA (Group for Research and Assessment of Psoriasis and Psoriatic Arthritis) composite exercise (GRACE) study were used for these analyses. Alternative definitions of low disease activity were used with 6/7 and 7/7 of MDA items, and a criteria set mandating the 2 articular items and 3/5 alternate items (MDA-joints). Two reference questions were used as anchors: physician’s global opinion of MDA, and patient’s opinion on their disease control.Results.Substantial agreement was found between MDA, MDA-joints, PASDAS, and CPDAI. Compared to the 2 reference questions, the various definitions of low disease activity gave sensitivities that were generally worse than specificities, the latter being high (> 0.9) in most cases. Both PASDAS and CPDAI demonstrated good discrimination between the “low” and “high” disease activity states by all the MDA definitions. Using these data, with an MDA of 7/7 to define a very low disease cutoff, the corresponding values for PASDAS and CPDAI were 1.9 and 2, respectively.Conclusion.An MDA score of 7/7 is proposed as very low disease activity in psoriatic arthritis. Using this definition, the equivalent cutoffs for PASDAS and CPDAI are 1.9 and 2, respectively.

The 12-item Psoriatic Arthritis Impact of Disease Questionnaire: Construct Validity, Reliability, and Interpretability in a Clinical Setting

2016 ◽  
Vol 44 (3) ◽  
pp. 279-285 ◽  
Author(s):  
Marco Di Carlo ◽  
Andrea Becciolini ◽  
Valentina Lato ◽  
Chiara Crotti ◽  
Ennio Giulio Favalli ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Construct Validity ◽  
Disease Activity ◽  
Convergent Validity ◽  
Activity Index ◽  
Multivariable Analysis ◽  
Real Life ◽  
Life Quality ◽  
Biologic Treatment ◽  
Patient Reported

Objective.To study, in a real-life setting, the construct validity, the reliability, and the interpretability of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire in patients with psoriatic arthritis (PsA).Methods.In 144 consecutive patients with PsA (81 men and 63 women, mean age of 51.4 ± 12.8 yrs, and 77 receiving biologic treatment), the PsAID-12 and other patient-reported outcomes (PRO) were collected, such as the Dermatology Life Quality Index. Each patient underwent articular and skin assessment.Results.Construct validity: Factor analysis revealed a 2-factor result defined as the PsAID Symptom Score and the PsAID Skin Score. In determining convergent validity, significant correlations were found between the PsAID-12 and the clinical Disease Activity index for Psoriatic Arthritis (cDAPSA; ρ = 0.867, p < 0.0001). Multivariable analysis showed that the PsAID-12 is determined by the articular disease activity (cDAPSA, p < 0.0001), severity of psoriasis (PsO; physician’s global assessment, p < 0.0001), and the presence of a coexisting fibromyalgia (FM; p < 0.0001). Reliability: Cronbach’s alpha coefficient was 0.93 for the total PsAID-12. Interpretability: Applying the cDAPSA categorization of disease activity states, the PsAID-12 cutoff values resulted in 1.4 between remission and low disease activity (LDA), 4.1 between LDA and moderate disease activity (MDA), and 6.7 between MDA and high disease activity.Conclusion.The PsAID-12 is an excellent PRO to evaluate the effect of PsA. It should be carefully handled in patients with coexisting FM.

Rebound in Measures of Disease Activity and Symptoms in Corrona Registry Patients with Psoriatic Arthritis Who Discontinue Tumor Necrosis Factor Inhibitor Therapy after Achieving Low Disease Activity

2017 ◽  
Vol 45 (1) ◽  
pp. 78-82 ◽  
Author(s):  
Leslie R. Harrold ◽  
Bradley S. Stolshek ◽  
Sabrina Rebello ◽  
David H. Collier ◽  
Alex Mutebi ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Tumor Necrosis Factor Inhibitor ◽  
Disease Activity Index ◽  
Tnf Inhibitor ◽  
Low Disease Activity ◽  
Patient Reports ◽  
Factor Inhibitor ◽  
Necrosis Factor

Objective.Rebound may occur in patients with psoriatic arthritis (PsA) who discontinue TNF inhibitor (TNFi) therapy in low disease activity (LDA).Methods.Using physician and patient reports, we quantified rebound following TNFi discontinuation [defined as Clinical Disease Activity Index (CDAI) score > 10 or TNFi restart] and time to rebound in adults with PsA in LDA (CDAI score ≤ 10) at TNFi discontinuation.Results.Rebound occurred in 73% (69/94) of patients soon after discontinuation (median time to rebound 8.0 mos, 95% CI 6.0–12.0).Conclusion.Rebound occurred frequently in patients with PsA after TNFi discontinuation. TNFi discontinuation after achieving LDA should be carefully considered.

EFFICACY AND SAFETY OF TOFACITINIB IN PATIENTS WITH PSORIATIC ARTHRITIS IN REAL CLINICAL PRACTICE

2020 ◽  
Vol 58 (3) ◽  
pp. 268-275
Author(s):  
E. Yu. Loginova ◽  
Yu. L. Korsakova ◽  
E. E. Gubar ◽  
P. L. Karpova ◽  
T. V. Korotaeva
Keyword(s):  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Clinical Manifestations ◽  
Activity Score ◽  
Tender Joint Count ◽  
Efficacy And Safety ◽  
Low Disease Activity ◽  
Number Of Patients

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.

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