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1.
Mod Rheumatol ; : 1-26, 2021 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-33740386

RESUMO

In the treatment of rheumatoid arthritis (RA), Janus kinase inhibitors (jakinibs) represent an emerging class of targeted therapies in addition to biologics. The number of jakinibs has been growing and as of 2020, filgotinib was the latest jakinib to enter the international market for treating RA. Filgotinib has demonstrated preferential inhibition of JAK1-dependent cytokine signaling in in vitro assays. It has been evaluated in the DARWIN (phase 2) and FINCH (phase 3) series of clinical studies for treating patients with moderately-to-severely active RA. Filgotinib received regulatory approval in Japan and Europe in September 2020, while in August 2020 the United States Food and Drug Administration requested additional data from two ongoing clinical studies assessing the potential impact of filgotinib on sperm parameters. This article will review the pharmacological properties, efficacy, and safety of filgotinib as demonstrated in clinical studies. Expert opinion will be provided on jakinibs for RA treatment from the viewpoints of basic research and clinical practice.

2.
Arthritis Rheumatol ; 2021 Mar 07.
Artigo em Inglês | MEDLINE | ID: mdl-33682378

RESUMO

OBJECTIVE: To evaluate the effect of withdrawing ixekizumab in patients with psoriatic arthritis (PsA) who had achieved minimal disease activity (MDA) after open-label ixekizumab treatment. METHODS: SPIRIT-P3 was a multicenter, randomized, double-blind withdrawal study that enrolled biologic-naive adult patients with PsA to open-label ixekizumab (160 mg at week 0, 80 mg every two weeks [IXE Q2W]) for 36 weeks. Patients sustaining MDA for >3 consecutive months were randomized (between weeks 36-64) 1:1 to blinded IXE Q2W withdrawal (placebo) or continued IXE Q2W treatment up to week 104. The primary efficacy endpoint was time to relapse (loss of MDA) for randomized patients. Patients who relapsed were retreated with IXE Q2W until week 104. RESULTS: A total of 394 patients were enrolled and received open-label IXE Q2W. Of those, 158 (40%) patients achieved sustained MDA and were randomized to IXE Q2W withdrawal (placebo; N=79) or continued IXE Q2W treatment (N=79). Patients relapsed more rapidly with treatment withdrawal (median 22.3 weeks [95% CI 16.1-28.3]) vs continued IXE Q2W treatment (median not estimable, p<0.0001); 67 (85%) patients vs 30 (38%) patients relapsed, respectively. Median time to re-achieving MDA on retreatment was 4.1 weeks (95% CI 4.1-4.3); 64 (96%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment. Safety was consistent with the known safety profile for ixekizumab. CONCLUSION: Continued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic-naive patients with PsA. Retreatment with ixekizumab following relapse may restore disease control in case of treatment interruption.

3.
Clin Rheumatol ; 2021 Mar 02.
Artigo em Inglês | MEDLINE | ID: mdl-33655380

RESUMO

INTRODUCTION/OBJECTIVES: To evaluate changes in health-related quality of life (HRQoL) and productivity following treatment with intravenous (IV) golimumab in patients with psoriatic arthritis (PsA). METHODS: Patients were randomized to IV golimumab 2 mg/kg (n=241) at Weeks 0, 4, then every 8 weeks (q8w) through Week 52 or placebo (n=239) at Weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at Weeks 24, 28, then q8w through Week 52. Change from baseline in EuroQol-5 dimension-5 level (EQ-5D-5L) index and visual analog scale (EQ-VAS), daily productivity VAS, and the Work Limitations Questionnaire (WLQ) was assessed. Relationships between these outcomes and disease activity and patient functional capability were evaluated post hoc. RESULTS: At Week 8, change from baseline in EQ-5D-5L index (0.14 vs 0.04), EQ-VAS (17.16 vs 3.69), daily productivity VAS (-2.91 vs -0.71), and WLQ productivity loss score (-2.92 vs -0.78) was greater in the golimumab group versus the placebo group, respectively. At Week 52, change from baseline was similar in the golimumab and placebo-crossover groups (EQ-5D-5L index: 0.17 and 0.15; EQ-VAS: 21.61 and 20.84; daily productivity VAS: -2.89 and -3.31; WLQ productivity loss: -4.49 and -3.28, respectively). HRQoL and productivity were generally associated with disease activity and functional capability, with continued association from Week 8 through Week 52. CONCLUSION: IV golimumab resulted in early and sustained improvements in HRQoL and productivity from Week 8 through 1 year in patients with PsA. HRQoL and productivity improvements were associated with improvements in disease activity and patient functional capability. Key Points • In patients with active psoriatic arthritis (PsA), intravenous (IV) golimumab improved health-related quality of life (HRQoL) and productivity as early as 8 weeks and maintained improvement through 1 year • Improvements in HRQoL and productivity outcomes in patients with PsA treated with IV golimumab were associated with improvements in disease activity and patient functional capability outcomes • IV golimumab is an effective treatment option for PsA that can mitigate the negative effects of the disease on HRQoL and productivity.

4.
ACR Open Rheumatol ; 2021 Feb 11.
Artigo em Inglês | MEDLINE | ID: mdl-33570260

RESUMO

OBJECTIVE: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We compared 5-year adverse event (AE) incidence rates (IRs) between patients initiating tofacitinib and those initiating new biological disease-modifying antirheumatic drugs (bDMARDs) within the United States (US) Corrona RA registry. METHODS: IRs (number of first events/100 patient-years) of major adverse cardiovascular events (MACE), serious infection events (SIEs), herpes zoster (HZ), malignancies, and death were estimated among tofacitinib and bDMARD initiators, regardless of dose/schedule, between November 6, 2012 (US Food and Drug Administration tofacitinib approval), and July 31, 2018 (follow-up through January 31, 2019). Propensity score (PS) methods were used to control for nonrandom prescribing practices. Hazard ratios (HRs) were calculated to compare rates using multivariable-adjusted Cox regression. Different risk windows were used for acute (MACE, SIEs, HZ, and venous thromboembolic events [VTEs]) and long-term (malignancy and death) events. VTEs were assessed descriptively. RESULTS: For MACE, SIEs, and HZ, 1999 (3152.1 patient-years) and 8358 (12 869.4 years) tofacitinib and bDMARD initiators were included, respectively; for malignancy/death, 1999 (4505.6 patient-years) and 6354 (16 670.8 patient-years) initiators were included, respectively. AE rates were similar across cohorts, except for HZ, which was significantly higher with tofacitinib versus bDMARDs (PS-trimmed adjusted HR 2.32; 95% confidence interval [CI] 1.43-3.75). There were 45 (zero serious) and 88 (five serious) HZ events with tofacitinib and bDMARDs, respectively. Sensitivity analyses demonstrated similar results. VTE IRs (95% CI) were 0.29 (0.13-0.54) and 0.33 (0.24-0.45) for tofacitinib and bDMARDs, respectively. CONCLUSION: In this registry analysis, both cohorts had similar MACE, SIE, malignancy, death, and VTE rates; HZ rates were higher for tofacitinib initaitors than for bDMARD initiators.

5.
J Rheumatol ; 2021 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-33526618

RESUMO

OBJECTIVE: The long-term safety and efficacy of filgotinib (from phase 2 studies), with or without methotrexate (MTX), for the treatment of patients with rheumatoid arthritis was assessed in DARWIN 3, a long-term, open-label extension study (NCT02065700). METHODS: Eligible patients completing the 24-week DARWIN 1 (filgotinib + MTX) and DARWIN 2 (filgotinib monotherapy) studies entered DARWIN 3, where they received filgotinib 200 mg/day, except for 15 men who received filgotinib 100 mg/day. Safety analyses were performed using the safety analysis set and exposure-adjusted incidence rate (EAIR) of treatment-emergent adverse events (TEAEs) was calculated. Efficacy was assessed from baseline in the parent studies. RESULTS: Of 790 patients completing the phase 2 parent studies, 739 enrolled in the study. Through April 2019, 59.5% of patients had received ≥4 years of study drug. Mean (SD) exposure to filgotinib was 3.55 (1.57) years in the filgotinib + MTX group and 3.38 (1.59) years in the filgotinib monotherapy group. EAIR per 100 patient years of exposure (PYE) for TEAEs was 24.6 in the filgotinib + MTX group and 25.8 in the filgotinib monotherapy group, and for serious TEAEs, the EAIR was 3.1 and 4.3, respectively. ACR20/50/70 responses among patients remaining in the study could be maintained through 4 years, with 89.3%/69.6%/49.1% of filgotinib + MTX group and 91.8%/69.4%/44.4% of monotherapy group maintaining ACR20/50/70 responses based on observed data. CONCLUSION: Filgotinib was well tolerated with a 4-year safety profile comparable to that of the parent trials, both in patients receiving combination therapy with MTX or as monotherapy.

6.
J Rheumatol ; 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-33589547

RESUMO

Throughout 2020, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has been working to update the GRAPPA treatment recommendations for psoriasis and psoriatic arthritis (PsA). The planned methodology for this update was published previously, and herein we provide an update on progress so far, including details of the systematic literature searches undertaken. GRAPPA is committed to regular updates of its treatment recommendations to incorporate the many significant therapeutic advances that have taken place in the PsA literature since the previous recommendation publication in 2015. The development and updating of treatment recommendations for optimal treatment approaches for patients with PsA has been an important mission of the GRAPPA since its inception. GRAPPA is currently finalizing domain-specific recommendations with an aim to produce updated treatment recommendations for publication in 2021.

7.
J Rheumatol ; 2021 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-33589550

RESUMO

A summary of the research conducted by the recipients of the 2019 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) Research Awards is presented. Dr. Alla Ishchenko's project was "Role of Metabolomics in Diagnosis, Disease Severity, and Progression in Psoriasis and Psoriatic Arthritis: A 2-year Prospective Pilot Study" and Dr. Zhenrui Shi's project was "Preclinical Analysis of CCR6 and CCL20 in Mouse and Human Joints, Respectively, as Targets of Therapeutic Intervention in Psoriatic Arthritis."

8.
Artigo em Inglês | MEDLINE | ID: mdl-33242358

RESUMO

OBJECTIVE: Psoriatic arthritis (PsA) can have a significant impact on health-related quality of life (HRQoL). Data on the timing of changes in the HRQoL of patients with PsA are limited. The present study was undertaken to explore associations between sleep disturbance, fatigue, pain, anxiety, depression, general health status, and satisfaction with life before and after a diagnosis of PsA compared to the general population. METHODS: Patients diagnosed with PsA between the Nord-Trøndelag Health Study (HUNT2 [1995-1997] and HUNT3 [2006-2008]) surveys were compared to the general population. The adjusted odds ratio (ORadj ) with 95% confidence interval (95% CI) was estimated at both time points. RESULTS: Among 36,507 individuals participating in both the HUNT2 and HUNT3 surveys, 160 were diagnosed with PsA between the surveys. The prevalence of sleep disturbances and fatigue was higher in PsA patients after diagnosis compared to the general population (ORadj 2.24 [95% CI 1.55-3.25] and ORadj 1.94 [95% CI 1.27-2.98], respectively). The prevalence of pain and poor health status were higher in patients with PsA compared with the general population even before PsA was diagnosed (ORadj 2.81 [95% CI 1.96-4.02] and ORadj 3.08 [95% CI 2.19-4.35], respectively) and increased after diagnosis of PsA (ORadj 12.87 [95% CI 6.27-26.40] and ORadj 5.63 [95% CI 3.99-7.95], respectively). For anxiety, depression, and life satisfaction, patients who developed PsA were comparable to the general population both before and after the diagnosis of PsA. CONCLUSION: Compared to the general population, PsA patients reported a higher prevalence of pain and poorer health status before diagnosis. Increased prevalence of sleep disturbances and fatigue in PsA patients was only found after the PsA diagnosis, and no differences between patients with PsA and the control group were found for anxiety and depression.

9.
Value Health ; 23(10): 1286-1291, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33032771

RESUMO

OBJECTIVES: Evaluate the effects of intravenous golimumab 2 mg/kg on multiple domains of health-related quality of life (HRQoL) in adult patients with active psoriatic arthritis (PsA). METHODS: In this phase III, randomized, double-blinded, placebo-controlled study, adults with active PsA were randomized in a 1:1 ratio to receive intravenous (IV) infusions of placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Physical function was assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). HRQoL was assessed using the 36-item Short-Form Health Survey Physical and Mental Component Summary (SF-36 PCS/MCS) scores, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, EQ VAS, and the Dermatology Life Quality Index (DLQI). RESULTS: Patients in the golimumab group had greater mean changes from baseline in HAQ-DI compared with placebo at weeks 8 (-0.52 vs -0.10), 14 (-0.60 vs -0.12), and 24 (-0.63 vs -0.14). Mean improvements from baseline in SF-36 PCS (8.0 vs 1.7), SF-36 MCS (5.0 vs 1.2), EQ VAS (17.2 vs 3.7), FACIT-Fatigue (7.9 vs 2.0), and DLQI (-7.2 vs -1.7) were also greater in the golimumab group versus placebo at week 8 and were maintained or increased through week 24. Greater proportions of golimumab-treated patients had improvements greater than or equal to the minimal clinically important difference (MCID) for HAQ-DI, SF-36 PCS/MCS, EQ VAS, FACIT-Fatigue, and DLQI scores at weeks 14 and 24. CONCLUSION: Improvements in HRQoL were greater in the IV golimumab group compared with placebo and were evident at week 8 and sustained through week 24.

10.
ACR Open Rheumatol ; 2(11): 640-647, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33073933

RESUMO

OBJECTIVE: To evaluate whether intravenous (IV) golimumab produces improvements in skin and nail symptoms that are concomitant with improvements in quality of life (QoL) and joint symptoms in patients with psoriatic arthritis. METHODS: Patients were randomized to either IV golimumab 2 mg/kg at weeks 0, 4, then every 8 weeks (q8w) through week 52 or placebo at weeks 0, 4, then q8w, with crossover to IV golimumab 2 mg/kg at weeks 24, 28, and then q8w through week 52. Assessments included Psoriasis Area and Severity Index (PASI), modified Nail Psoriasis Severity Index (mNAPSI), Dermatology Life Quality Index (DLQI), and American College of Rheumatology (ACR) rheumatoid arthritis response criteria. RESULTS: Through week 24, achievement of PASI 75/90/100 responses (P ≤ .0098) and mean improvements in mNAPSI (-11.4 vs -3.7; P < .0001) and DLQI (-9.8 vs -2.9; P < .0001) were significantly greater with golimumab versus placebo. Responses were maintained in patients treated with golimumab through week 52. In placebo-crossover patients, increases in the proportion of patients achieving PASI 75/90/100 responses were observed from weeks 24 to 52, and mean improvements in mNAPSI (from -3.7 to -12.9) and DLQI (from -2.9 to -7.8) increased from weeks 24 to 52. Simultaneous achievement of PASI and DLQI responses, PASI and ACR responses, and mNAPSI and DLQI responses were also observed. Similar responses were observed for all assessments regardless of concomitant methotrexate use. CONCLUSION: Improvements in skin and nail psoriasis symptoms with IV golimumab in patients with psoriatic arthritis were concomitant with improvements in QoL and arthritis disease activity through 1 year.

11.
J Am Acad Dermatol ; 2020 Jul 30.
Artigo em Inglês | MEDLINE | ID: mdl-32738429

RESUMO

Psoriasis is a chronic, inflammatory, multisystem disease which affects up to 3.2% of the U.S population. This guideline addresses important clinical questions that arise in psoriasis management and care and provides recommendations based on the available evidence. The treatment of psoriasis with topical agents and with alternative medicine (AM) will be reviewed, emphasizing treatment recommendations and the role of dermatologists in monitoring and educating patients regarding benefits as well as risks that may be associated. This guideline will also address the severity assessment methods of psoriasis in adults.

12.
Arthritis Res Ther ; 22(1): 198, 2020 08 26.
Artigo em Inglês | MEDLINE | ID: mdl-32847612

RESUMO

INTRODUCTION: Sleep disturbances, fatigue, and anxiety/depression in psoriatic arthritis (PsA) may be influenced by skin and musculoskeletal manifestations. All of these in turn affect the psychosocial impact of disease. The objective was to explore the occurrence of sleep disturbances, fatigue, and anxiety/depression in psoriatic arthritis (PsA) patients, and their correlates. METHODS: A broad data collection was performed in 137 Norwegian PsA outpatient clinic patients including demographics, disease activity measures for both skin and musculoskeletal involvement, and patient-reported outcome measures. Sleep disturbances and fatigue were defined present if the numeric rating scale (0-10) score was ≥ 5. Anxiety/depression was assessed using a questionnaire (1-3; 1 defined as no anxiety/depression). Descriptive statistics was applied, and associations were explored using univariate and adjusted linear regression analysis. RESULTS: The mean age was 52.3 years, PsA disease duration 8.8 years; 49.6% were men and 54.8% were currently employed/working. The prevalence of sleep disturbances was 38.0%, fatigue 44.5%, and anxiety/depression 38.0%. In adjusted analysis, pain, fatigue, and higher mHAQ were associated with sleep disturbances. Sleep disturbances, pain, and anxiety/depression were associated with fatigue, whereas only fatigue was associated with anxiety/depression. CONCLUSIONS: The prevalence of sleep disturbances, fatigue, and anxiety/depression was frequently reported by PsA patients. No measures reflecting skin involvement or objective measures of musculoskeletal involvement were independently associated with sleep disturbances, fatigue, or anxiety/depression. Our data suggest that patients' perceptions of musculoskeletal involvement (pain or mHAQ) play an important role causing sleep disturbances and fatigue, whereas fatigue in PsA patients is strongly associated with anxiety/depression.

13.
ACR Open Rheumatol ; 2(8): 459-470, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32710493

RESUMO

OBJECTIVE: Psoriatic arthritis (PsA) requires long-term treatment, yet safety concerns and monitoring requirements make maintenance a challenge. This analysis of pooled Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) 1, 2, and 3 data describes 3-year apremilast safety and tolerability in PsA. METHODS: Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily. Placebo patients were re-randomized to apremilast 30 mg twice daily or 20 mg twice daily at week 16 (early escape) or 24. Double-blind treatment continued to week 52; patients could continue apremilast during an open-label, long-term treatment phase. RESULTS: In total, 1493 patients received at least one dose of study medication and were included in the safety population (placebo: n = 495; apremilast 30 mg: n = 497; apremilast 20 mg: n = 501). Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment. Greater rates of adverse events (AEs) were reported with apremilast (61.1%; exposure-adjusted incidence rate [EAIR]/100 patient-years, 265.1) versus placebo (47.5%; EAIR/100 patient-years, 200.7) in the placebo-controlled period. During weeks 0 to ≤52, the most common AEs occurring in apremilast-exposed patients were diarrhea (13.9%; EAIR/100 patient-years, 18.6), nausea (12.3%; EAIR/100 patient-years, 16.0), headache (9.4%; EAIR/100 patient-years, 12.1), upper respiratory tract infection (9.1%; EAIR/100 patient-years, 11.5), and nasopharyngitis (6.2%; EAIR/100 patient-years, 7.7). Most AEs were mild/moderate with apremilast exposure ≤156 weeks. Rates of depression remained low (EAIR/100 patient-years, 1.8). Major adverse cardiac events (EAIR/100 patient-years, 0.5), malignancies (EAIR/100 patient-years, 0.9), and serious opportunistic infections (EAIR/100 patient-years, 0.0) were infrequent over the 3-year exposure period. Discontinuation rates due to AEs were low (<7.5%) across all apremilast-exposure periods. Incidences of clinically meaningful abnormalities in postbaseline laboratory values was low; most values returned to baseline levels with continued treatment and without intervention. CONCLUSION: Apremilast demonstrated a favorable safety profile and was well tolerated up to 156 weeks.

14.
J Rheumatol Suppl ; 96: 41-45, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32482767

RESUMO

The development and updating of treatment recommendations for optimal treatment approaches for patients with psoriatic arthritis (PsA) has been an important mission of the Group for Research and Assessment of Psoriasis and PsA (GRAPPA) since its inception. Even though the most recent iteration of the GRAPPA PsA recommendations was completed only a few years ago, there have been many significant advances related to therapies and treatment approaches for PsA since their publication. Because of these advances, the process to update the recommendations again has begun. The standard approaches to guideline (or treatment recommendation) development have also evolved in recent years. Herein, the basis for the approach that will be taken for the next version of the GRAPPA PsA treatment recommendations is reviewed.

15.
Clin Exp Rheumatol ; 38(6): 1227-1230, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32452352

RESUMO

OBJECTIVES: To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire. METHODS: In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period. RESULTS: In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs compared to placebo at Week 24. CONCLUSIONS: Treatment with ixekizumab was associated with clinically meaningful improvements in WPAI-SHP domains in biologic-naive and TNFi- experienced patients with active PsA.

16.
RMD Open ; 6(1)2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32409518

RESUMO

BACKGROUND: In psoriatic arthritis (PsA), both psoriasis and musculoskeletal manifestations may impair Health-Related Quality of Life (HRQoL). Our objective was to explore the impact of the various disease manifestations and disease consequences, including psychosocial factors, on HRQoL in PsA patients treated in the biologic treatment era. METHODS: Data collection in the 131 outpatient clinic PsA patients assessed included demographics, disease activity measures for both skin and musculoskeletal involvement and patient-reported outcome (PRO) measures, treatment and psychosocial burden. The skin dimension of quality of life was assessed by the Dermatology Life Quality Index (DLQI) and the overall HRQoL by the 15-Dimensional (15D) Questionnaire. RESULTS: The mean age was 51.9 years, PsA disease duration 8.6 years, 50.4% were men, 56.9% were employed/working and 47.7% had ≥1 comorbidities. Prevalence of monotherapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was 36.6% and with biologic DMARDs 12.2% and combination of both 22.9%. Mean DLQI was 3.3 and 15D 0.84. In adjusted analysis, not employed/working, higher scores for fatigue, sleep disturbances, anxiety and depression, Modified Health Assessment Questionnaire and presence of comorbidities were independently associated with impaired HRQoL (lower 15D scores), whereas Psoriasis Area Severity Index (PASI) and DLQI were not. Younger age and higher Psoriatic Arthritis Disease Activity Score and PASI scores were independently associated with impaired skin quality of life (higher DLQI score). CONCLUSION: Our study highlights the negative impact the psychosocial burden, impaired physical function and comorbidities has on reduced HRQoL in PsA outpatients. Thus, to further improve HRQoL in PsA patients, not only physical concerns but also psychological concerns need to be addressed.

17.
Lancet ; 395(10235): 1496-1505, 2020 05 09.
Artigo em Inglês | MEDLINE | ID: mdl-32386593

RESUMO

BACKGROUND: Head-to-head trials in psoriatic arthritis are helpful in guiding clinical decision making. The EXCEED study evaluated the efficacy and safety of secukinumab versus adalimumab as first-line biological monotherapy for 52 weeks in patients with active psoriatic arthritis, with a musculoskeletal primary endpoint of American College of Rheumatology (ACR) 20 response. METHODS: This parallel-group, double-blind, active-controlled, phase-3b, multicentre (168 sites in 26 countries) trial enrolled patients aged at least 18 years with active psoriatic arthritis. Eligible patients were randomly assigned (1:1) by means of interactive response technology to receive secukinumab or adalimumab. Patients, investigators, site personnel, and those doing the assessments (except independent study drug administrators) were masked to study assignment. 300 mg secukinumab was administered subcutaneously at baseline, weeks 1, 2, 3, and 4, and then every 4 weeks until week 48 as a pre-filled syringe. Adalimumab was administered every 2 weeks from baseline until week 50 as 40 mg per 0·4 mL citrate free subcutaneous injection. The primary outcome was the proportion of patients with at least 20% improvement in the ACR response criteria (ACR20) at week 52. Patients were analysed according to the treatment to which they were randomly assigned. Safety analyses included all safety data reported up to and including the week 52 visit for each patient who received at least one dose of study drug. The trial is registered at ClinicalTrials.gov, NCT02745080. FINDINGS: Between April 3, 2017 and Aug 23, 2018, we randomly assigned 853 patients to receive secukinumab (n=426) or adalimumab (n=427). 709 (83%) of 853 patients completed week 52 of the study, of whom 691 (81%) received the last study treatment at week 50. 61 (14%) of 426 patients in the secukinumab group discontinued treatment by week 52 versus 101 (24%) of 427 patients in the adalimumab group. The primary endpoint of superiority of secukinumab versus adalimumab for ACR20 response at week 52 was not met. 67% of patients in the secukinumab group achieved an ACR20 response at week 52 versus 62% of patients in the adalimumab group (OR 1·30, 95% CI 0·98-1·72; p=0·0719). The safety profiles of secukinumab and adalimumab were consistent with previous reports. Seven (2%) of 426 patients in the secukinumab group and six (1%) of 427 patients in the adalimumab group had serious infections. One death was reported in the secukinumab group due to colon cancer and was assessed as not related to the study drug by the investigator. INTERPRETATION: Secukinumab did not meet statistical significance for superiority versus adalimumab in the primary endpoint of ACR20 response at week 52. However, secukinumab was associated with a higher treatment retention rate than adalimumab. This study provides comparative data on two biological agents with different mechanisms of action, which could help guide clinical decision making in the management of patients with psoriatic arthritis. FUNDING: Novartis Pharma.


Assuntos
Adalimumab/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Tomada de Decisão Clínica , Método Duplo-Cego , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Segurança , Resultado do Tratamento
18.
Artigo em Inglês | MEDLINE | ID: mdl-32361743

RESUMO

Elderly-onset RA (EORA) and polymyalgia rheumatica (PMR) are common rheumatic diseases in the elderly. Oxylipins are bioactive lipids derived from omega-6 (n-6) and omega-3 (n-3) polyunsaturated fatty acids (PUFA) that serve as activators or suppressors of systemic inflammation. We hypothesized that arthritic symptoms in the elderly were related to oxylipins-related perturbations. Arthritis in the Elderly (ARTIEL) is an observational prospective cohort with 64 patients >60 years of age with newly diagnosed arthritis. Patients' blood samples at baseline and 3 months posttreatment were compared with 18 controls. A thorough clinical examination was conducted. Serum oxylipins were determined by mass spectrometry. Data processing and statistical analysis were performed in R. Forty-four patients were diagnosed with EORA and 20 with PMR. At diagnosis, EORA patients had a mean DAS28CRP (Disease Activity Score 28 using C reactive protein) of 5.77 (SD, 1.02). 100% of PMR patients reported shoulder pain and 90% reported pelvic pain. Several n-6- and n-3-derived oxylipin species were significantly different between controls and arthritis patients. The ratio of n-3/n-6 PUFA was significantly downregulated in EORA but not in PMR patients as compared to controls. The top two candidates as biomarkers for differentiating PMR from EORA were 4-HDoHE, a hydroxydocosahexaenoic acid, and 8,15-dihydroxy-eicosatrienoic acid (8,15-diHETE). The levels of n-3 derived anti-inflammatory species increased in EORA after treatment. These results suggest that certain oxylipins may be key effectors in arthritis in the elderly and that the imbalance between n-6 and n-3 derived oxylipins might be related to pathobiology in this population.

19.
J Rheumatol ; 47(12): 1831-1834, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-32238512

RESUMO

OBJECTIVE: Burnout among physicians is common and has important implications. We assessed the extent of burnout among rheumatology practitioners and its associations. METHODS: One hundred twenty-eight attendees at the 2019 Rheumatology Winter Clinical Symposium were surveyed using the Maslach Burnout Index (MBI) and a demographics questionnaire. Scores for emotional exhaustion (EE) ≥ 27, depersonalization (DP) ≥ 10, and personal accomplishment (PA) ≤ 33 were considered positive for burnout. Data regarding practitioner characteristics including age, sex, years in practice, and other demographics of interest were also collected. These data were used to determine prevalence and interactions of interest between practitioner characteristics and the risk of burnout. RESULTS: Of the 128 respondents, 50.8% demonstrated burnout in at least 1 MBI domain. Dissatisfaction with electronic health records was associated with a 2.86-times increased likelihood of burnout (OR 2.86, 95% CI 1.23-6.65, P = 0.015). Similar results were found for lack of exercise (OR 5.00, 95% CI 1.3-18.5, P = 0.016) and work hours > 60 per week (OR 2.6, 95% CI 1.16-5.6, P = 0.019). Practitioners in group practice were 57% less likely to burn out (OR 0.43, 95% CI 0.20-0.92, P = 0.029), as were those who spend > 20% of their time in personally satisfying work (OR 0.32, 95% CI 0.15-0.71, P = 0.005). CONCLUSION: In what we believe to be one of the largest studies regarding burnout among rheumatology practitioners, we found a substantial prevalence of burnout, with 51% of all respondents meeting criteria in at least 1 domain defined by the MBI and 54% of physicians meeting these same criteria.

20.
Arthritis rheumatol. (Malden. Online) ; 72(4): [461-488], Apr. 4, 2020.
Artigo em Inglês | BIGG - guias GRADE | ID: biblio-1117247

RESUMO

To develop an evidence-based guideline on contraception, assisted reproductive technologies (ART), fertility preservation with gonadotoxic therapy, use of menopausal hormone replacement therapy (HRT), pregnancyassessment and management, and medication use in patients with rheumatic and musculoskeletal disease (RMD). We conducted a systematic review of evidence relating to contraception, ART, fertility preservation,HRT, pregnancy and lactation, and medication use in RMD populations, using Grading of Recommendations Assessment, Development and Evaluation methodology to rate the quality of evidence and a group consensus process todetermine final recommendations and grade their strength (conditional or strong). Good practice statements wereagreed upon when indirect evidence was sufficiently compelling that a formal vote was unnecessary.. This American College of Rheumatology guideline provides 12 ungraded good practice statements and131 graded recommendations for reproductive health care in RMD patients. These recommendations are intended toguide care for all patients with RMD, except where indicated as being specific for patients with systemic lupus erythematosus, those positive for antiphospholipid antibody, and/or those positive for anti-Ro/SSA and/or anti-La/SSBantibodies. Recommendations and good practice statements support several guiding principles: use of safe andeffective contraception to prevent unplanned pregnancy, pre-pregnancy counseling to encourage conception during periods of disease quiescence and while receiving pregnancy-compatible medications, and ongoing physicianpatient discussion with obstetrics/gynecology collaboration for all reproductive health issues, given the overall low level of available evidence that relates specifically to RMD. Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to the recommendations within this guideline to be voluntary, with the ultimate determination regarding their application to be made by the clinician in light of each patient's individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes, but cannot guarantee any specific outcome. Guidelines and recommendations developed and endorsed by the ACR are subject to periodic revision, as warranted by the evolution of medical knowledge, technology, and practice. ACR recommendations are not intended to dictate payment or insurance decisions. These recommendations cannot adequately convey all uncertainties and nuances of patient care. The American College of Rheumatology is an independent, professional, medical and scientific society that does not guarantee, warrant, or endorse any commercial product or service. This guideline provides evidence-based recommendations developed and reviewed by panels of experts and RMD patients. Many recommendations are conditional, reflecting a lack of data or low-level data. We intend that this guideline be used to inform a shared decision-making process between patients and their physicians on issues related to reproductive health that incorporates patients' values, preferences, and comorbidities.


Assuntos
Humanos , Doenças Reumáticas/prevenção & controle , Doenças Reumáticas/terapia , Doenças Musculoesqueléticas/prevenção & controle , Doenças Musculoesqueléticas/terapia , Saúde Reprodutiva
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