Work Productivity Loss and Fatigue in Psoriatic Arthritis

2014 ◽  
Vol 41 (8) ◽  
pp. 1670-1674 ◽  
Author(s):  
Jessica A. Walsh ◽  
Molly L. McFadden ◽  
Michael D. Morgan ◽  
Allen D. Sawitzke ◽  
Kristina Callis Duffin ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Depressed Mood ◽  
Activity Index ◽  
Productivity Loss ◽  
Work Productivity ◽  
Inflammatory Back Pain ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Life Questionnaire ◽  
Tender Joint

Objective.To explore the relationship between fatigue and work productivity loss (WPL) in people with psoriatic arthritis (PsA).Methods.Data were collected from participants in the Utah Psoriasis Initiative Arthritis registry between January 2010 and May 2013. WPL was measured with the 8-item Work Limitations Questionnaire. Fatigue was assessed with question 1 from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI#1), “How would you describe the overall level of fatigue/tiredness you have experienced?” and with question 1 from the Psoriatic Arthritis Quality of Life Questionnaire (PsAQOL#1) “I feel tired whatever I do.” Psoriatic activity was evaluated with tender joint count (TJC), swollen joint count (SJC), dactylitis count, enthesitis count, inflammatory back pain (IBP), physician global assessment, body surface area, and psoriasis pain and itch.Results.Among 107 participants, work productivity was reduced by 6.7%, compared to benchmark employees without limitations. Fatigue was reported by 54 patients (50.5%) on PsAQOL#1, and 64 (60.0%) were classified as high fatigue by BASDAI#1. TJC, SJC, enthesitis count, IBP, and depressed mood were highest or most frequent in participants reporting fatigue. After adjustments for psoriatic activity and depressed mood, WPL was associated with fatigue, as measured by PsAQOL#1 (p = 0.01) and BASDAI#1 (p = 0.002).Conclusion.WPL was associated with fatigue, and the association was not entirely explained by the evaluated musculoskeletal, cutaneous, or psychiatric manifestations of PsA.

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
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Health Assessment ◽  
Severity Index ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Minimal Disease Activity ◽  
Tender Joint ◽  
Minimal Disease

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.

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

Rheumatology ◽  
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.

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 SAT0419 ASSOCIATION OF ACTIVE MRI SACROILIITIS WITH DACTYLITIS AND WORK PRODUCTIVITY IMPAIRMENT IN PSORIATIC ARTHRITIS PATIENTS. POSITIVE EFFECTS OF TOFACITINIB TREATMENT. DATA FROM CLINICAL PRACTICE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1162.2-1163
Author(s):  
E. Gubar ◽  
T. Korotaeva ◽  
Y. Korsakova ◽  
E. Loginova ◽  
S. Glukhova ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Clinical Examination ◽  
Kinase Inhibitor ◽  
Statistical Significance ◽  
Severe Disease ◽  
Work Productivity ◽  
Janus Kinase ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Positive Effects

Background:Psoriatic arthritis (PsA) is a heterogeneous disease with multiple manifestations and choosing among treatments can be a complex decision. Patients (pts) with axial involvement and pts having dactylitis are more likely to develop a severe disease (1, 2). Tofacitinib (TOFA), an oral Janus kinase inhibitor, showed efficacy in treating PsA pts with dactylitis (3). However, its efficacy in treating PsA pts with activesacroiliitis(SI) and dactylitis has not been studied.Objectives:To study the effect of TOFA therapy in PsA pts having active SI on MRI (MRI-SI) and dactylitis.Methods:40 pts (M/F – 23/17) with active PsA fulfilling the CASPAR criteria were examined. Median (Me) age 41.0 [35.0; 50.0] yrs, Me PsA duration 6.0 [3.0; 10.0] yrs. A standard clinical examination of PsA activity was performed: Me tender joint count 19 [12; 24], swollen joint count 11 [8; 16], patient’s global disease activity measured by Visual Analogue Scale (VAS) 70 [50; 80], patient’s pain VAS 65 [50; 75], Me activity indexes: DAPSA 44.2 [37.8; 55.3], BASDAI 6.0 [4.2; 7.0], ASDAS 3.8 [2.8; 4.4]. CRP 21.3 [3.2; 72.3] mg/L, ESR 28 [12; 52] mm/h. Enthesitis was observed in 65.9% of pts with Me LEI index 1 [0; 1], dactylitis in 53.7% of pts, Me digits with dactylitis 1 [0; 2]. Apart from a standard clinical examination, MRI of sacroiliac joints (SIJs) was performed in all 40 pts using MRI scanner Siemens General Electric 1.5 TESLA. Bone marrow edema/osteitis on MRI (STIR) considered active MRI sacroiliitis (MRI-SI), was evaluated by 2 independent readers (radiologist and rheumatologist). TOFA was given in 5 mg tablets bds over a period of 6 months, after which 35 patients underwent SIJ MRI. Me [Q25; Q75], Pierson-χ2tests were performed. All p<0.05 were considered to indicate statistical significance.Results:Prior to TOFA therapy, MRI-SI was detected in 14 of 40 (35.0%) pts. At the end of 6 months therapy, MRI-SI was detected in 4 of 35 (11.4%) pts: in 3 pts with baseline SI; 1 pt showed negative dynamics, that is, development of active SI (absent at baseline). The decrease in number of active MRI-SI pts is statistically significant (p=0.017; Pearson-χ2). Significant differences between baseline symptoms in patients with MRI-SI (n=14) and without it (n=26) were definedby number of digits with dactylitis:2 [0; 4] and 0 [0; 2] (p=0.047),by ESR: 47 [26; 76] and 20 [6; 37] mm/h (p=0.025), and byWPAI overall work impairment due to health index:80 [60; 84]% and 20 [0; 60]% (р=0.033), respectively; these parameters were higher in MRI-SI subgroup. After 6 months of therapy number of digits with dactylitis, ESR and WPAI indexes were significantly lower as compared with the baseline ones (Table 1).After 6 months of TOFA therapy, no differences were found between groups of pts with and without MRI-SI in the number of digits with dactylitis (p=0.47), in ESR (p=0.79) and in WPAI (p=0.93).Conclusion:In PsA pts significant association of active MRI-SI was found with dactylitis, high ESR level and WPAI. Use of TOFA in pts with both active MRI-SI and dactylitis demonstrated its high efficacy in reduction of SI inflammation and dactylitis; it also significantly improved pts’ work productivity. These findings are important for personalized approach to treatment of PsA.References:[1]Brockbank JE et al. Ann Rheum Dis. 2005;64(2):188-90[2]Mease PJ et al. J Rheumatol 2018;45:1389-96[3]Gladman DD et al. N Engl J Med 2017;377:1525-36Disclosure of Interests:ELENA GUBAR: None declared, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Yulia Korsakova: None declared, Elena Loginova Speakers bureau: Janssen, Svetlana Glukhova: None declared, Polina Karpova: None declared

scholarly journals SAT0418 EFFECT OF TOFACITINIB TREATMENT ON ACTIVE MRI SACROILIITIS AND DISEASE ACTIVITY REDUCTION IN PSORIATIC ARTHRITIS PATIENTS. DATA FROM CLINICAL PRACTICE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1162.1-1162
Author(s):  
E. Gubar ◽  
T. Korotaeva ◽  
Y. Korsakova ◽  
E. Loginova ◽  
P. Karpova
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Clinical Examination ◽  
Kinase Inhibitor ◽  
Statistical Significance ◽  
Janus Kinase ◽  
Inflammatory Back Pain ◽  
Tender Joint Count ◽  
Tender Joint ◽  
Axial Involvement

Background:Axial involvement in psoriatic arthritis (PsA) is quite common. Tofacitinib (TOFA) is an oral Janus kinase inhibitor. There is no data on the use of TOFA in PsA patients (pts) with axial involvement, nor is there any data on its effect on active MRI sacroiliitis (MRI-SI). There are only preliminary results of a randomized clinical trial on TOFA efficacy on active SI in AS (1).Objectives:To study the effect of TOFA therapy on active MRI-SI in PsA pts.Methods:40 pts (F/M – 23/17) with active PsA fulfilling the CASPAR criteria were examined. No patients with inflammatory back pain (IBP) were specifically selected. Median (Me) age 41.0 [35.0; 50.0] yrs, Me PsA duration 6.0 [3.0; 10.0] yrs. Pts underwent a standard clinical examination of PsA activity: Me tender joint count 19 [12; 24], swollen joint count 11 [8; 16], patient’s global disease activity measured by Visual Analogue Scale (VAS) 70 [50; 80], patient’s pain VAS 65 [50; 75], Me activity indixes: DAPSA 44.2 [37.8; 55.3], BASDAI 6.0 [4.2; 7.0], ASDAS 3.8 [2.8; 4.4]. Me CRP 21.3 [3.2; 72.3] mg/L, ESR 28 [12; 52] mm/h. Enthesitis was observed in 65.9% of pts, dactylitis in 53.7% of pts. Apart from a standard clinical examination, all 40 pts underwent sacroiliac joint (SIJ) MRI on scanner Siemens General Electric 1.5 TESLA. Bone marrow edema/osteitis on MRI (STIR) with one lesion on two consecutive slices or at least two lesions on a single slice, was considered active MRI-SI. MRI results were evaluated by 2 independent readers (radiologist and rheumatologist). TOFA was given in 5 mg tablets bds over a period of 6 months, after which 35 patients underwent SIJ MRI. Me [Q25; Q75], Pierson-χ2tests were performed. All p<0.05 were considered to indicate statistical significance.Results:Prior to TOFA therapy, active MRI-SI was detected in 14 of 40 (35%) pts: bilateral in 9 pts, unilateral in 5 pts. At the end of 6 months therapy, active MRI-SI was detected in 4 of 35 (11.4%) pts observed: in 1 pt with baseline bilateral MRI-SI and in 2 pts with unilateral MRI-SI. 1 pt showed negative dynamics, that is, development of active MRI-SI (absent at baseline). The decrease in number of active MRI-SI patients is statistically significant (p = 0.017; Pearson-χ2). At baseline, inflammatory changes were detected in 23 of 80 (28.8%) SIJs, after 6 months of therapy they were found in 5 of 70 (7.1%) SIJs observed. Decrease in number of SIJs with active inflammation is statistically significant (p = 0.001; Pearson-χ2). At baseline, Me BASDAI 6.0 [4.2; 7.0], Me ASDAS 3.8 [2.8; 4.4]. After 6 months of treatment, Me BASDAI 1.4 [0.6; 3.2], Me ASDAS1.5 [1.0; 2.1] (p = 0.001 for both comparisons).Conclusion:JAK inhibition using TOFA therapy shows high efficacy in reducing active MRI-SI and decreasing activity of axial involvement in PsA. More extensive studies are needed.References:[1]van der Heijde D. et al. Ann. Rheum. Dis. 2017;76:1340–47Disclosure of Interests:ELENA GUBAR: None declared, Tatiana Korotaeva Grant/research support from: Pfizer, Consultant of: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Speakers bureau: Abbvie, BIOCAD, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck Sharp & Dohme, Novartis, Novartis-Sandoz, Pfizer, UCB, Yulia Korsakova: None declared, Elena Loginova Speakers bureau: Janssen, Polina Karpova: None declared

scholarly journals POS1012 HOW IMPORTANT WOULD BE THE IMPACT OF SPONDYLOARTHRITIS ON MILITARY POPULATION’S WORKING LIFE?

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 774.2-774
Author(s):  
T. Mehmli ◽  
R. Dhahri ◽  
M. Slouma ◽  
E. Hannech ◽  
B. Louzir ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Disease Activity ◽  
Activity Index ◽  
Productivity Loss ◽  
Young Patients ◽  
Work Productivity ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Military Patients ◽  
The Impact

Background:Spondyloarthritis is a group of chronic inflammatory diseases involving axial and peripheral joints. It mainly affects young patients typically of working age. Therefore, its impact on work outcomes may be considerable particularly in military patients.Objectives:The aim of this study was to evaluate the impact of spondyloarthritis on work ability and productivity in military patients, and to assess relationship between work productivity loss and disease activity.Methods:Thirty Three patients diagnosed with spondyloarthritis in the militay hospital of Tunis were included in the study. Age, gender and C-reactive protein were recorded. Data related to duration of the disease, Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were also recorded. Employed patients completed Work Productivity and Activity Impairment (WPAI) questionnaire witch assesses four subscales: presenteism, absenteism, overall work impairemend and daily activity impairement in the 7 past days.Results:Among the thirty three patients, 63 % were men and 37% were women. The average age was 43,7 ± 13,5. The average duration of disease was 8,5 ± 7,75 years. Mean C-Reactive protein was 27,5 ± 39,3. Mean ASDAS and BASDAI were 3,12 ± 1,39 and 4,26 ± 1,78 respectively. 22 patients (66%) had an active disease and 11 (33%)were in remission. 48,4% of patients were using NSAIDs, 48,4% were under DMARDs and 42% were under biologics (12 patients using TNF-alpha blockers and 2 patients were given IL-17 inhibitors). Among this patients, 27 were employed. Three patients (11%) had a total work disability and were retired from work and two have been outplaced.Employed patients worked an average of 35,6 ± 10,3 hours per week and missed an average of 3,48 ± 6,49 hours per week. The mean rates of absenteeism, presenteeism and work productivity loss were 8,8 ± 16,9 %, 48,4 ± 19,9 % and 48,6 ± 19,7 %.There was a statistically significant correlation between BASDAI and work missed hours (p<0,05, r=0,48), absenteeism (p<0,05, r=0,48), presenteeism (p<0,01, r=0,669), work impairement (p<0,01, r=0,669), activity impairement (p<0,05, r=0,475) and work productivity loss (p<0,05, r=0,475), as well as between ASDAS CRP and presenteeism (p<0,05, r= 0,593), work impairement (p<0,05, r=0,593), activity impairement(p<0,05, r=0,460) and work productivity loss (p<0,05, r=0,460). No relation was found between WPAI indexes and C-reactive protein.Conclusion:This study demonstrates that spondyloarthritis has a major impact on military patients’ work productivity with a significant correlation between WAPI indexes and disease activity scores (ASDAS CRP and BASDAI). No relation was found with C-reactive protein.Disclosure of Interests:None declared.

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.

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

2016 ◽  
Vol 43 (9) ◽  
pp. 1724-1734 ◽  
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.

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 O23 Ixekizumab (IXE) vs. adalimumab (ADA) for the treatment of PSA: 52-week efficacy and safety outcomes

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Christopher J Edwards ◽  
Andrew J Bradley ◽  
Mani H Nassab ◽  
Burkhard Möller ◽  
Klaus P Machold ◽  
...  
Keyword(s):  
Severe Psoriasis ◽  
Tender Joint Count ◽  
Stock Ownership ◽  
Physician Global Assessment ◽  
Inadequate Response ◽  
Full Time ◽  
Research Support ◽  
Open Label ◽  
Tender Joint ◽  
Full Time Employee

Abstract Background With multiple biologic disease-modifying anti-rheumatic drugs (bDMARDs) available, comparisons are important for treatment decisions. At week 24 of the SPIRIT H2H study in patients with active PSA, IXE showed superiority to ADA for the simultaneous achievement of ACR50 and PASI100. Here we report the 52-week efficacy outcomes including individual ACR components and in subgroups +/- concomitant methotrexate (MTX). Methods SPIRIT H2H (NCT03151551) was a 52-week, multicentre, open-label, blinded-assessor study of bDMARD naïve patients with active PSA (defined as swollen joint count ≥3/68, and tender joint count ≥3/66), with a body surface area (BSA) ≥3% and inadequate response to conventional synthetic (cs)-DMARDs. Patients were randomised 1:1 to IXE or ADA stratified by concomitant csDMARD use and the presence of moderate-to-severe psoriasis (defined as Psoriasis Area and Severity Index [PASI] ≥12 combined with a static Physician Global Assessment ≥3 and BSA ≥10%). Patients received approved label dosing of assigned treatment dependent on presence/absence of moderate-to-severe psoriasis. Primary outcome was achievement of simultaneous ACR50 + PASI100; secondary outcomes were achievement of PASI100, ACR20/50/70 and changes in individual ACR component scores. Data were analysed using logistic regression with non-responder imputation for missing data. Results Baseline characteristics were balanced across treatment groups. At week 52, a significantly larger percentage of IXE- vs. ADA-treated patients achieved simultaneous ACR50 + PASI100 and PASI100, consistent with 24-week results (table). IXE performed at least as well as ADA at week 52 for all other outcomes (table). With/without MTX, IXE efficacy was consistent at week 52 across ACR20/50/70 with a significantly greater achievement of simultaneous ACR50 + PASI100 and ACR70 (table). IXE- versus ADA-treatment resulted in comparable changes from baseline for each individual ACR component at week 52. Safety was consistent with previous reports. Conclusion In patients with PSA, treatment with IXE versus ADA resulted in a significantly greater achievement of simultaneous skin and joint improvement at week 52, consistent with week 24 results. At week 52 consistent efficacy was shown for IXE when used with/without MTX. Disclosures C.J. Edwards: Consultancies; Celltrion, Abbvie, Samsung. Honoraria; Abbvie, BMS, Biogen, Chugai, Fresenius, Gilead, Janssen, Lilly, Pfizer, Roche, Samsung, UCB. Member of speakers’ bureau; Abbvie, BMS, Biogen, Chugai, Fresenius, Gilead, Janssen, Lilly, Pfizer, Roche, Samsung, UCB. Grants/research support; Pfizer, Biogen, Abbvie. A.J. Bradley: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. M.H. Nassab: Other; Full time employee of Eli Lilly. B. Möller: None. K.P. Machold: Honoraria; Arsanis, Astro, Baxter, BMS, Celgene, Eli-Lilly, MSD, Pfizer, Roche, Novartis, Sandoz. Member of speakers’ bureau; MSD, Pfizer, BMS, Janssen-Cilag, Sandoz, Novartis, Eli-Lilly. Grants/research support; AbbVie, BMS, Eli-Lilly, Novartis, MSD, Pfizer, Sanofi-Aventis, UCB. C. Sapin: Shareholder/stock ownership; Eli Lilly. Other; Full time employee of Eli Lilly. R. Ranza: Consultancies; Abbvie, Novartis, Lilly, Pfizer, Janssen. Member of speakers’ bureau; Abbvie, Novartis, Lilly, Pfizer, Janssen. Grants/research support; Abbvie, Novartis, Pfizer, Janssen. S.L. Leage: Other; Full time employee of Eli Lilly.

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