scholarly journals Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.

2009 ◽  
Vol 69 (01) ◽  
pp. 48-53 ◽  
Author(s):  
L C Coates ◽  
J Fransen ◽  
P S Helliwell

Objective:To create minimal disease activity (MDA) criteria for psoriatic arthritis (PsA). With recent therapeutic advances, this is now a goal for treatment and may represent a measure to compare therapies. It defines a satisfactory state of disease activity rather than a change, and encompasses all aspects of the disease.Methods:40 patient profiles were sampled from an observational PsA database. Sixty experts in PsA classified these as in MDA or not. A consensus of ⩾70% was accepted, identifying 13 profiles in MDA. Summary statistics created possible cut-off points for the definition. Considering the number of measures that must be met, 35 candidate definitions were created and tested using receiver operating characteristic curves (ROC) for sensitivity and specificity.Results:Four candidate definitions showed high area under the curve values on ROC testing. Definitions with high outlying values were excluded as they were not considered to represent MDA. Aiming for high specificity to reduce false positives resulted in a preference for the following definition: “A patient is classified as achieving MDA when meeting 5 of the 7 following criteria: tender joint count ⩽1; swollen joint count ⩽1; Psoriasis Activity and Severity Index ⩽1 or body surface area ⩽3; patient pain visual analogue score (VAS) ⩽15; patient global disease activity VAS ⩽20; health assessment questionnaire ⩽0.5; tender entheseal points ⩽1”.Conclusion:This study provides the first definition of a “state” of MDA in PsA and defines a target for treatment. It must now be validated in other populations and tested in clinical trials.


2016 ◽  
Vol 43 (5) ◽  
pp. 907-910 ◽  
Author(s):  
Josefina Marin ◽  
María Laura Acosta Felquer ◽  
Leandro Ferreyra Garrot ◽  
Santiago Ruta ◽  
Javier Rosa ◽  
...  

Objective.To evaluate components of the minimal disease activity (MDA) criteria in psoriatic arthritis (PsA).Methods.In patients achieving and not achieving MDA, fulfillment of each of the 7 criteria was evaluated.Results.Among 41 patients with MDA, 7.4% did not fulfill the tender/swollen joint count whereas 49% did not fulfill the skin criteria. Of the 42 patients not fulfilling MDA, 100%, 76.5%, and 65% did not fulfill the patient pain score, the patient’s global assessment, and the Psoriasis Area and Severity Index (PASI), respectively.Conclusion.A minority of patients with PsA fulfilling the MDA criteria presented active joints, but half had active skin. Visual analog scale scores and the PASI prevented patients from achieving MDA.


2017 ◽  
Vol 45 (1) ◽  
pp. 6-13 ◽  
Author(s):  
Laure Gossec ◽  
Dennis McGonagle ◽  
Tatiana Korotaeva ◽  
Ennio Lubrano ◽  
Eugenio de Miguel ◽  
...  

As in other inflammatory rheumatic diseases, the objective of psoriatic arthritis (PsA) treatment is the achievement of a defined target. Recent recommendations propose aiming for remission or low disease activity; however, a consensual definition of remission is lacking. A state of minimal disease activity (MDA) has been established and is defined by low activity assessed by tender/swollen joint counts, tender entheseal points, Psoriasis Area and Severity Index or body surface area, patient pain and global activity visual analog scale, and functional evaluation by Health Assessment Questionnaire. Since its development, MDA has been used increasingly in studies and clinical trials. In this article, the potential use of MDA as a treatment target in PsA is reviewed. The frequencies of MDA achievement with biologic disease-modifying antirheumatic drugs are summarized based on data from registries, observational studies, and clinical trials. Predictors and the prognostic effect of attaining MDA are also evaluated.


Rheumatology ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 869-873 ◽  
Author(s):  
Sravan Kumar Appani ◽  
Phani Kumar Devarasetti ◽  
Rajendra Vara Prasad Irlapati ◽  
Liza Rajasekhar

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.


2015 ◽  
Vol 43 (2) ◽  
pp. 350-355 ◽  
Author(s):  
Fabio Massimo Perrotta ◽  
Antonio Marchesoni ◽  
Ennio Lubrano

Objective.A state of remission is the target of therapy in chronic arthritis. The aim of the present study was to assess the rate of minimal disease activity (MDA) and remission in patients with psoriatic arthritis (PsA) treated with tumor necrosis factor (TNF-α) blockers. Disease characteristics and predictors of MDA were also evaluated.Methods.Patients fulfilling the ClASsification for Psoriatic ARthritis (CASPAR) criteria and treated with TNF-α blockers adalimumab, etanercept, or golimumab were enrolled and prospectively followed every 4 months for 1 year in a clinical practice setting. Patients were considered in MDA when they met at least 5/7 of the criteria previously defined. Other remission criteria evaluated were 28-joint Disease Activity Score-C-reactive protein (DAS28-CRP) < 2.6 and Disease Activity in Psoriatic Arthritis (DAPSA) score ≤ 3.3. Patients achieving MDA were compared to non-MDA to identify outcome predictor factors.Results.Of the 75 patients treated with TNF-α blockers, at baseline no patients were in MDA or had a DAPSA score ≤ 3.3, while 25 (21.3%) had a DAS28-CRP score < 2.6. Five patients (6%) discontinued treatment because of side effects or inefficacy during followup. After 12 months, MDA was achieved in 46 patients (61.3%). No difference was found among the 3 anti-TNF-α drugs. Predictors for MDA were found to be male sex, high CRP, high erythrocyte sedimentation rate, and low Health Assessment Questionnaire.Conclusion.In our prospective observational study, based on a clinical practice setting, MDA was achieved in 61.3% of patients treated with TNF-α blockers, identifying this as an achievable target for patients with PsA. Predictors of remission were also identified.


BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e016619 ◽  
Author(s):  
Proton Rahman ◽  
Michel Zummer ◽  
Louis Bessette ◽  
Philip Baer ◽  
Boulos Haraoui ◽  
...  

ObjectiveTo describe the minimal disease activity (MDA) rate over time in patients with psoriatic arthritis (PsA) receiving antitumour necrosis factor agents, evaluate prognostic factors of MDA achievement and identify the most common unmet criteria among MDA achievers.DesignBiologic Treatment Registry Across Canada (BioTRAC): ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis or PsA with infliximab (IFX), golimumab (GLM) or ustekinumab.Setting46 primary-care Canadian rheumatology practices.Participants223 patients with PsA receiving IFX (enrolled since 2005) and GLM (enrolled since 2010) with available MDA information at baseline, 6 months and/or 12 months.Primary and secondary outcome measuresMDA was defined as ≥5 of the following criteria: 28-item tender joint count (TJC28) ≤1, 28-item swollen joint count (SJC28) ≤1, Psoriasis Area and Severity Index (PASI) ≤1 or body surface area≤3, Pain Visual Analogue Scale (VAS) ≤15 mm, patient’s global assessment (PtGA) (VAS) ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, tender entheseal points ≤1. Independent prognostic factors of MDA achievement were assessed with multivariate logistic regression.ResultsMDA was achieved by 11.7% of patients at baseline, 43.5% at 6 months, 44.8% at 12 months and 48.8% at either 6 or 12 months. Among MDA achievers at 6 months, 75.7% had sustained MDA at 12 months. Lower baseline HAQ (OR=0.210; 95% CI: 0.099 to 0.447) and lower TJC28 (OR=0.880; 95% CI: 0.804 to 0.964), were significant prognostic factors of MDA achievement over 12 months of treatment. The most commonly unmet MDA criteria among MDA achievers was patient reported pain (25%), PtGA (15%) and PASI (12%).ConclusionsAlmost 50% of patients treated with IFX or GLM in routine clinical care achieved MDA within the first year of treatment. Lower baseline HAQ and lower TJC28, were identified as significant prognostic factors of MDA achievement. The most commonly unmet criteria in patients who achieved MDA were pain, PtGA and PASI.Trial registration numberBioTRAC (NCT00741793).


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 310.1-310
Author(s):  
E. Loginova ◽  
T. Korotaeva ◽  
E. Gubar ◽  
S. Glukhova

Background:The goal of treat to target strategy (T2T) in psoriatic arthritis (PsA) is attaining remission or minimal disease activity (MDA). The benefits of T2T have been seen recently [1]. But prognostic factors for MDA achievement in PsA patients (pts) at an early-stage hasn’t been studied yet.Objectives:to determine the prognostic factors associated with MDA achievement within 12 months (mos.) of treatment according to T2T strategy in early PsA pts.Methods:77 pts (M/F=36/41) with early active PsA fulfilling the CASPAR criteria were included. Mean age 36.9±10.45 years (yrs.), PsA duration 11.1±10.0 mos., Psoriasis (PsO) duration 82.8±92.1 mos. At baseline (BL) and at 12 mos. of therapy PsA activity by tender joint count (TJC)/68, swelling joint count (SJC)/66, Pain (VAS), Patient global assessment disease activity (PtGA, VAS), CRP mg/l, dactylitis, enthesitis by LEI and plantar fascia, BSA (%), HAQ and fatigue by FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale (Version 4) were evaluated. A score FACIT <30 indicates severe fatigue and > 30 – less fatigue. All pts was given therapy with Methotrexate (MTX) s/c. After 3-9 mos. of ineffectiveness of MTX treatment 29 pts were given biologic DMARDs. By 12 mos. of therapy, the proportion of pts who had reached MDA (5/7) were calculated. Pts were split into 2 groups: MDA + (n=45) and MDA - (n=32). The one-factor model of logistic regression was used to identify a group of features that are associated with MDA achievement. M±SD, Me [Q25; Q75], Min-Max, %, t-test, Pierson-χ2, Manna-Whitney tests, ORs with 95% CI were performed. All p<0.05, were considered to indicate statistical significance.Results:Comparative analysis in both groups and one-factor model of logistic regression showed the following features at BL were associated with MDA achievement: TJC/SJC < 3 (p<0.001), PGA ≤ 20 mm (p<0.001), Pain (VAS) ≤ 15 mm (p<0.001), CRP ≤ 5 mg/l (p< 0.03), HAQ ≤ 0.5 (p< 0.001), FACIT > 30 (p< 0.021), absent of entesitis (p< 0.003), dactylitis (p< 0.029) and nail damage (p< 0.012). Early PsA pts with combination of these features at first visit have more chance to achieve MDA within 12 mos in comparison to PsA pts without them, OR=9.684 [CI 95% 4.6-20.4]. (Figure 1).Conclusion:It is a combination of features at first visit to clinic – TJC, SJC < 3, PGA ≤ 20 mm, pain ≤ 15 mm, CRP ≤ 5 mg/l, HAQ ≤ 0.5, FACIT > 30 points, absent of entesitis, dactylitis and nail PsO - that constitutes a clinical prognostic factors for MDA achievement within 12 mos of T2T strategy in early PsA pts.References:[1]Coates LC, et al. Lancet. 2015 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5Figure 1.The prognostic factors associated with achievement MDA within 12 months in early PsA ptsDisclosure of Interests:None declared


2016 ◽  
Vol 43 (9) ◽  
pp. 1718-1723 ◽  
Author(s):  
Barry J. Sheane ◽  
Arane Thavaneswaran ◽  
Dafna D. Gladman ◽  
Vinod Chandran

Objective.An international task force has recommended that disease remission or minimal disease activity (MDA) be the target of treatment for psoriatic arthritis (PsA) and that remission or MDA should be attained within 6 months of initiating medication. The aim of this study was to establish the proportion of patients with PsA who achieve MDA after 6 months of methotrexate (MTX) treatment.Methods.Patients who initiated MTX and were naive to biologics between 2004 and 2014 were included. The primary outcome was the achievement of MDA after 6 months of MTX, defined as the presence of at least 5 out of the following 7: tender joint count ≤ 1, swollen joint count (SJC) ≤ 1, Psoriasis Area Severity Index (PASI) ≤ 1 or body surface area ≤ 3%, tender entheseal points ≤ 1, Health Assessment Questionnaire score ≤ 0.5, patient global disease activity visual analog scale (VAS) score ≤ 20, and patient pain VAS ≤ 15. Of 204 patients identified, 167 were treated with MTX for at least 3 months and had sufficient data for analysis at 6 months.Results.At 6 months, 29 patients (17.4%) achieved MDA; 97 patients (58.1%) achieved an SJC ≤ 1 and 138 (82.6%) a PASI ≤ 1. Only 22 (13.2%) achieved the patient global disease activity criterion. Lower back pain and dactylitis were associated with a lower probability of achieving MDA.Conclusion.MTX use achieves MDA by 6 months in < 20% of patients. This compares unfavorably with data for tumor necrosis factor inhibitor use.


2019 ◽  
Vol 56 (6) ◽  
pp. 739-745
Author(s):  
E. Yu. Loginova ◽  
T. V. Korotaeva ◽  
A. D. Koltakova

The current Treat-to-target (T2T) strategy in the management of patients with psoriatic arthritis (PsA) is based on strict control over the dynamics of a patient's status and timely correction of therapy according to the presence or absence of remission or minimal disease activity (MDA) within 6 months after treatment initiation. The multidimensional RAPID3 questionnaire based on the patient's own opinion of his/her health status, has demonstrated its high effectiveness in assessing remission in patients with rheumatoid arthritis (RA). The possibilities of using the RAPID3 questionnaire in patients with early PsA (ePsA) with T2T strategy have not yet been studied.Objective: to investigate whether the multi-dimensional RAPID3 questionnaire may be used to assess the achievement of remission and MDA in ePsA patients with a T2T (Treat-to-target) strategySubjects and methods. The investigation enrolled 61 patients (29 men and 32 women) with ePsA meeting the 2006 CASPAR criteria; the mean age of the patients was 37±10.6 years; the duration of PsA and psoriasis was 11.3±10.2 and 75.4±80.9 months, respectively. The patients were followed up for 12 months during the open-label REMARCA study performed by the T2T principles. At baseline, all the patients were given methotrexate (MTX; Methoject) subcutaneously at a dose of 10 mg/week, with escalation by 5 mg every 2 weeks up to 20–25 mg/week. If there was no low disease activity (LDA), DAS28/DAS remission, or MDA after 3 months, the patients received combined therapy with MTX 20–25 mg/week and adalimumab (ADA) or ustekinumab (UST) at standard doses. All the patients underwent standard rheumatologic examination before therapy and every 3 months. The investigators calculated tender joint count (TJC) among 78 joints; swollen joint count (SJC) among 76 joints, the Ritchie articular index, and the number of entheses by the Leeds Enthesitis index (LEI). Joint pain measurement, patient (PGA) and physician (PhGA) global assessment on visual analog scale (VAS) was performed, the serum level of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were evaluated. DAS and DAS28, HAQ and RAPID3 functional index were estimated. The number of patients achieving LDA, DAS/DAS28 remission, and MDA were determined. Results and discussion. At 1 year of therapy, 36 (59%) out of the 61 patients and 25 (41%) out of the 61 patients were treated with MTX and this drug in combination with ADA or UST, respectively. After 1 year of treatment, the whole group displayed a significant improvement of all PsA activity parameters as compared with baseline values: DAS, 3.93 [3.20; 4.58] / 1.36 [0.82; 2.25], SJC, 7 [5; 11] / 1 [0; 3], TJC, 8 [6; 1] / 1 [0; 3], PhGA, 56 [48; 69] / 10 [5; 20] and VAS pain, 54 [48; 68] / 11 [1; 20], PGA, 55 [49; 68] / 14 [7; 24], HAQ, 0.75 [0.50; 1] / 0 [0; 0.63], respectively. There was a significant correlation of RAPID3 with PsA activity and CRP. MDA was seen in 43 (70.5%) out of the 61 patients. Among the patients who had achieved MDA, the RAPID3 values corresponded to remission, but were significantly higher in the patients who had not attained MDA: 2.5 [1.3; 5.3] and 8.1 [6.0; 15.1], respectively. RAPID3 demonstrated high sensitivity in assessing the achievement of remission, LDA, and MDA in patients with ePsA.Conclusion. RAPID3 based on a patient's personal opinion of his/her disease is a simple and reliable tool to assess the disease activity in patients with ePsA and to monitor the efficiency of therapy with a T2T strategy and may be really useful in practice.


2009 ◽  
Vol 36 (12) ◽  
pp. 2788-2794 ◽  
Author(s):  
MARTIN J. BERGMAN ◽  
SHADI S. SHAHOURI ◽  
TIMOTHY S. SHAVER ◽  
JAMES D. ANDERSON ◽  
DAVID N. WEIDENSAUL ◽  
...  

Objective.To investigate whether fatigue is an inflammatory (rheumatoid arthritis; RA) variable, the contributions of RA variables to fatigue, and the levels of fatigue in RA compared with osteoarthritis (OA) and fibromyalgia (FM).Methods.We studied 2096 RA patients, 1440 with OA, and 1073 with FM in a clinical setting, and 14,607 RA, 3173 OA, and 2487 patients with FM in survey research. We partitioned variables into inflammatory and noninflammatory factors and examined variable contribution to fatigue (0–10 visual analog scale).Results.Factor analysis identified Disease Activity Score-28 (DAS28) and swollen (SJC) and tender joint count (TJC) as a physician-inflammation factor, and patient global assessment, pain, Health Assessment Questionnaire, and fatigue as patient components. Fatigue demonstrated weak correlations with erythrocyte sedimentation rate (ESR; r = 0.071) and SJC (r = 0.112), weak to fair correlations with TJC (r = 0.294), physician global assessment of RA activity (r = 0.384), and DAS28 (r = 0.399), but strong correlation with patient global assessment of severity (r = 0.567). In hierarchical regression analysis, patient global explained 43.1% of DAS28 fatigue variance; when SJC, TJC, and ESR were entered, the explained variance increased to 43.7%. In reverse order, SJC, TJC, and ESR explained 9.2% of the variance, but explained variance increased to 43.7% when patient global was added. The mean clinic fatigue scores were RA 4.9, OA 4.8, FM 7.6; mean survey scores were RA 4.5, OA 4.4, FM 6.3. Adjusted for age and sex, RA and OA fatigue scores were not significantly different.Conclusion.Inflammatory components of the DAS28 contribute minimally to fatigue. RA and OA fatigue levels do not differ. Fatigue is not an inflammatory variable and has no unique association with RA or RA therapy.


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