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

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]

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-211998 ◽

2017 ◽

Vol 77 (2) ◽

pp. 251-257 ◽

Cited By ~ 22

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.

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Effects of ustekinumab on spondylitis-associated endpoints in TNFi-naïve active psoriatic arthritis patients with physician-reported spondylitis: pooled results from two phase 3, randomised, controlled trials

RMD Open ◽

10.1136/rmdopen-2019-001149 ◽

2020 ◽

Vol 6 (1) ◽

pp. e001149 ◽

Cited By ~ 3

Author(s):

Philip S Helliwell ◽

Dafna D Gladman ◽

Soumya D Chakravarty ◽

Shelly Kafka ◽

Chetan S Karyekar ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Ankylosing Spondylitis ◽

Disease Activity ◽

Activity Index ◽

Hip Pain ◽

Assessment Tools ◽

Interleukin 12 ◽

Hla B27 ◽

Clinical Trial Registration ◽

Link Type

BackgroundThe interleukin-12/23p40-subunit-inhibitor ustekinumab significantly improved spondylitis-related symptoms through Week 24 in psoriatic arthritis (PsA) patients with peripheral arthritis and physician-reported spondylitis (PA-PRS) in PSUMMIT-1&2. We further evaluated ustekinumab’s effect on spondylitis-related endpoints in PSUMMIT-1&2 tumour necrosis factor-inhibitor (TNFi)-naïve patients with PA-PRS.MethodsPatients with active PsA (≥5 swollen and ≥5 tender joints, C-reactive-protein ≥ 3.0 mg/L) despite conventional (PSUMMIT-1&2) and/or prior TNFi (PSUMMIT-2) therapy received subcutaneous ustekinumab 45 mg, 90 mg or placebo (Week 0, Week 4, Week 16). Changes in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) neck/back/hip pain question (#2) and modified BASDAI (mBASDAI, excluding PA) scores and Ankylosing Spondylitis Disease Activity Score (ASDAS) responses were assessed at Weeks 12 and 24.ResultsThe pooled PSUMMIT-1&2, TNFi-naïve (n=747), PA-PRS (n=223) subset (158 with human-leucocyte-antigen (HLA)-B27 results) presented with moderate-to-severe spondylitis-related symptoms (mean BASDAI-neck/back/hip pain-6.51, mBASDAI-6.54, BASDAI-6.51, ASDAS-3.81). Mean Week 24 changes were larger among ustekinumab than placebo-treated patients for both neck/back/hip pain (−1.99 vs −0.18) and mBASDAI (−2.09 vs −0.59). Improvements in neck/back/hip pain and fatigue appeared numerically greater in HLA-B27+ than HLA-B27– patients; those for other domains were generally consistent. Greater proportions of ustekinumab versus placebo-treated patients achieved ASDAS clinically important improvement at Week 24 (decrease ≥ 1.1; 49.6% vs 12.7%; nominal p<0.05).ConclusionsImprovements in BASDAI neck/back/hip pain and mBASDAI among ustekinumab-treated, TNFi-naïve, PsA patients with PA-PRS were clinically meaningful and consistent across assessment tools. Numerically greater improvements in neck/back/hip pain in HLA-B27+ than HLA-B27– patients, noted in the context of similar overall mBASDAI improvements between the subgroups, suggest ustekinumab may improve disease activity in TNFi-naïve PsA patients likely to exhibit axial disease.Clinical trial registration numbersPSUMMIT 1, NCT01009086; PSUMMIT 2, NCT01077362.

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Measuring disease activity in psoriatic arthritis: PASDAS implementation in a tightly monitored cohort reveals residual disease burden

Rheumatology ◽

10.1093/rheumatology/keaa766 ◽

2020 ◽

Author(s):

Michelle L M Mulder ◽

Tamara W van Hal ◽

Frank H J van den Hoogen ◽

Elke M G J de Jong ◽

Johanna E Vriezekolk ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Disease Burden ◽

Residual Disease ◽

Clinical Care ◽

Cross Sectional Study ◽

Inflammatory Back Pain ◽

Tender Joint Count ◽

Tender Joint ◽

Cross Sectional

Abstract Objectives We aimed to investigate the disease activity and overall disease burden of (subgroups of) patients with PsA using the Psoriatic Arthritis Disease Activity Score (PASDAS) in an already tightly monitored cohort. Methods This is a cross-sectional study evaluating data from the first visit of 855 PsA patients after implementation of the PASDAS in our tightly monitored cohort [e.g. DAS 28 (DAS28) was provided as an anchor]. Differences in clinical outcomes between subgroups of patients using established cut-offs for disease activity status [i.e. very low (VLDA), low (LDA), moderate (MDA), and high disease activity (HDA)] were examined. Results Based on the PASDAS, 53.1% of patients were in VLDA/LDA. 29.5% of patients had ≥1 swollen joint, 20.6% had ≥1 enthesitis index point and 3.0% had active dactylitis. Based on DAS28, 77.5% of the patients were in VLDA/LDA. Patients reaching both DAS28 VLDA/LDA status and PASDAS VLDA/LDA status [N = 445 (52.0%)] were compared with patients reaching only DAS28 VLDA/LDA status [N = 218 (25.5%)]. For these latter patients, significantly worse scores on separate parameters were found in measures used for PASDAS/DAS28 calculation (e.g. swollen and tender joint count and patient’s visual analogue scale global disease activity) as well as other disease measures (e.g. function and inflammatory back pain). This result remained, even when the stricter VLDA cut-off was used for the DAS28. Conclusion PASDAS implementation uncovered relevant residual disease activity in a quarter of patients previously assessed as being in DAS28 VLDA/LDA, underscoring the potential value of PASDAS measurements in PsA clinical care.

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Residual Disease Activity and Associated Factors in Psoriatic Arthritis

The Journal of Rheumatology ◽

10.3899/jrheum.190679 ◽

2019 ◽

Vol 47 (10) ◽

pp. 1490-1495 ◽

Cited By ~ 1

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.

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

The Journal of Rheumatology ◽

10.3899/jrheum.200934 ◽

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.

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The efficacy and safety of apremilast in patients with psoriatic arthritis concurrent with comorbidity in clinical practice

Rheumatology Science and Practice ◽

10.14412/1995-4484-2019-299-306 ◽

2019 ◽

Vol 57 (3) ◽

pp. 299-306

Author(s):

E. Yu. Loginova ◽

Yu. L. Korsakova ◽

A. D. Koltakova ◽

E. E. Gubar ◽

P. L. Karpova ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Skin Lesions ◽

Tender Joint Count ◽

Psoriatic Skin ◽

Efficacy And Safety ◽

Tender Joint ◽

Number Of Patients ◽

Conventional Dmards ◽

Low Activity

Objective: to evaluate the clinical efficacy and safety of the targeted synthetic disease-modifying antirheumatic drug (DMARD) apremilast (AP; Otesla®) in patients with active psoriatic arthritis (PsA) at 14 and 26 weeks after starting the treatment and to identify the place of AP in the combination therapy of patients with PsA, by taking into consideration a comorbidity.Subjects and methods. Examinations were made in 20 patients (11 women and 9 men) with active PsA who had comorbidity, lack of efficiency of or intolerance to previous therapy with synthetic DMARDs or biologic agents, and contraindications to its use. The median baseline Disease Activity in Psoriatic Arthritis (DAPSA) score was 35.6 [24.8; 55.6]; those of DAS and DAS28 were 3.8 [3.2; 5.0] and 4.4 [4.0; 5.2], respectively. AP (Otesla®) was administered in tablets with a starting dose of 10 mg/day with a daily dose escalation of 10 mg to the therapeutic dose of 60 mg/day for 26 weeks. At baseline, 14 and 26 weeks, the disease activity and efficiency of AP were evaluated using DAPSA, DAS, and DAS28, as well as minimal disease activity (MDA) criteria (tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or BSA ≤3%; a patient’s assessment of pain ≤15 mm; patient’s global assessment ≤ 20 mm; Health Assessment Questionnaire (HAQ) ≤ 0.5; enthesitis ≤1). The investigators estimated the number of patients who had achieved remission (DAPSA≤4; DAS<1.6; DAS28<2.6), low activity (5≤DAPSA≤14; 1.6≤DAS<2.4; 2.6≤DAS28<3.2) or MDA (5 of the 7 criteria) during AP therapy at 26-week follow-up. The safety of therapy was evaluated, by analyzing the adverse events (AE): the frequency, severity, and time of their occurrence were studied.Results and discussion. At 26 weeks after AP therapy initiation, there was a significant decrease of all PsA activity scores as compared to the baseline ones to the following median values: DAPSA 25.9 [11.3; 35.2]; DAS 3.3 [1.8; 3.9], and DAS28 3.4 [2.3; 4.8]. The median BASDAI and ASDAS scores also significantly declined from 5.1 [2.5; 7.3] and 3.35 [2.3; 4.2] to 3.45 [2.15; 6.15] and 2.7 [1.8; 3.35], respectively. The median area of psoriatic skin lesions (body surface area (BSA)) significantly reduced from 2 [0.35; 6] to 1 [0.2; 2]. At 26 weeks after starting AP therapy, the low activity/remission according to DAPSA, DAS, and DAS28 was achieved by 20/10%, 20/15%, and 10/35% of patients, respectively. Three (15%) patients achieved MDA. Fifteen (75%) of the 20 patients completed an AP therapy course. In the period of 14 to 26 weeks, four patients dropped out of the study due to ineffective therapy and one because of a severe AE (pneumonia at 14 weeks of treatment); at 26 weeks, another patient was withdrawn due to lack of effect. At 14 weeks, ten patients had a moderate AE that did not required treatment discontinuation. The most common AE were diarrhea in 5 (25%) patients, headache in 4 (20%), nausea in 3 (15%), and insomnia in 3 (15%).Conclusion. AP is a safe and effective drug for the treatment of PsA patients with moderate and high inflammatory activity and various comorbidities that do not allow the use of conventional DMARDs.

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Can disease activity in patients with psoriatic arthritis be adequately assessed by a modified Disease Activity index for PSoriatic Arthritis (DAPSA) based on 28 joints?

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2018-213463 ◽

2018 ◽

Vol 77 (12) ◽

pp. 1736-1741 ◽

Cited By ~ 6

Author(s):

Brigitte Michelsen ◽

Joseph Sexton ◽

Josef S Smolen ◽

Daniel Aletaha ◽

Niels Steen Krogh ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Construct Validity ◽

Disease Activity ◽

Conversion Factor ◽

Activity Index ◽

Disease Activity Index ◽

Joint Disease ◽

Tender Joint ◽

Low Disease Activity ◽

National Quality

ObjectiveTo test the psychometric performance of a modified Disease Activity index for PSoriatic Arthritis (DAPSA) using 28 instead of 66 swollen/68 tender joint counts (SJC/TJC).MethodsWe included patients with psoriatic arthritis (PsA) from the Danish national quality registry DANBIO, divided into examination (n=3157 patients, 23987 visits) and validation cohorts (n=3154 patients, 24160 visits). We defined DAPSA28 = (28TJC × conversion factor1) + (28SJC × conversion factor2) + patient global (0–10VAS) + pain (0–10VAS) + C reactive protein (CRP) (mg/dL). Identification of the conversion factors was performed by generalised estimating equations in the examination cohort and evaluation of criterion, correlational and construct validity in the validation cohort.ResultsWe estimated DAPSA28 = (28TJC × 1.6) + (28SJC × 1.6) + patient global (0–10VAS) + pain (0–10VAS) + CRP (mg/dL). Criterion validity: DAPSA/DAPSA28 had comparable discriminative power expressed as standardised mean difference (DAPSA, 0.90; DAPSA28, 0.93) to distinguish between patients in high and low disease activity. Kappa with quadratic weighting of DAPSA/DAPSA28 disease activity states was high: 0.92 (95% CI 0.92 to 0.92). Standardised response means for DAPSA/DAPSA28 were –0.96/–0.92 for visits after biological DMARD-initiation. Correlational validity: Baseline DAPSA/DAPSA28 had high correlation with 28-joint disease activity score with CRP (r=0.87/r=0.93), simplified disease activity index (r=0.92/r=0.99), p<0.001. Bland-Altman plot showed better agreement between DAPSA/DAPSA28 for low than high disease activity. Construct validity: DAPSA/DAPSA28 were similarly correlated to Health Assessment Questionnaire; r=0.60/0.62, p<0.001. DAPSA/DAPSA28 discriminated patients reporting their symptom state as acceptable versus not acceptable equally well: mean (SD) 9.1 (8.7)/8.4 (8.0) and 24.2 (14.9)/22.5 (13.8), respectively.ConclusionOur study suggests that data sets with only 28-joint counts available can be used to calculate DAPSA28, especially in patients with low disease activity. DAPSA28 showed good criterion, correlational and construct validity and sensitivity to change. Still, our results support that 66/68 joint count should be performed and the original DAPSA should be preferred in PsA.

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

Rheumatology ◽

10.1093/rheumatology/key369 ◽

2018 ◽

Vol 58 (5) ◽

pp. 869-873 ◽

Cited By ~ 2

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.

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A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial

The Journal of Rheumatology ◽

10.3899/jrheum.151376 ◽

2016 ◽

Vol 43 (9) ◽

pp. 1724-1734 ◽

Cited By ~ 93

Author(s):

Maurizio Cutolo ◽

Gary E. Myerson ◽

Roy M. Fleischmann ◽

Frédéric Lioté ◽

Federico Díaz-González ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Physical Function ◽

Controlled Trial ◽

Signs And Symptoms ◽

Adenosine Monophosphate ◽

Phase Iii ◽

Tender Joint Count ◽

Upper Respiratory Tract ◽

Tender Joint ◽

Link Type

Objective.Apremilast, an oral phosphodiesterase 4 inhibitor, downregulates intracellular inflammatory mediator synthesis by elevating cyclic adenosine monophosphate levels. The PALACE 2 trial evaluated apremilast efficacy and safety in patients with active psoriatic arthritis (PsA) despite prior conventional disease-modifying antirheumatic drugs and/or biologic therapy.Methods.Eligible patients were randomized (1:1:1) to placebo, apremilast 20 mg BID, or apremilast 30 mg BID. At Week 16, patients with swollen and tender joint count improvement < 20% entered early escape, with placebo patients rerandomized (1:1) to apremilast 20 mg BID or 30 mg BID while apremilast patients continued on their initial apremilast dose. At Week 24, patients remaining on placebo were rerandomized to apremilast 20 mg BID or 30 mg BID. The primary endpoint was the proportion of patients achieving > 20% improvement in American College of Rheumatology response criteria (ACR20) at Week 16.Results.In the intent-to-treat population (N = 484), ACR20 at Week 16 was achieved by more patients receiving apremilast 20 mg BID [37.4% (p = 0.0002)] and 30 mg BID [32.1% (p = 0.0060)] versus placebo (18.9%). Clinically meaningful improvements in signs and symptoms of PsA, physical function, and psoriasis were observed with apremilast through Week 52. The most common adverse events were diarrhea, nausea, headache, and upper respiratory tract infection. Diarrhea and nausea generally occurred early and usually resolved spontaneously with continued treatment. Laboratory abnormalities were infrequent and transient.Conclusion.Apremilast demonstrated clinical improvements in PsA for up to 52 weeks, including signs and symptoms, physical function, and psoriasis. No new safety signals were observed. ClinicalTrials.gov identifier: NCT01212757.

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

Rheumatology ◽

10.1093/rheumatology/keaa030 ◽

2020 ◽

Vol 59 (8) ◽

pp. 1818-1825 ◽

Cited By ~ 1

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.

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