Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment

Strand, Vibeke; Sharp, Veronika; Koenig, Andrew; Park, Grace; Shi, Yifei; Wang, Brian; Zack, Debra; Fiorentino, David

doi:10.1136/annrheumdis-2011-200387

Cited by 128 publications

(113 citation statements)

References 40 publications

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“…As reported in other studies, SF‐36 PCS and MCS scores were not substantially impaired at baseline;3 however, significant improvements from baseline to values above the normal population were reported with tofacitinib treatment. In addition, unlike other inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis, which affect the joints, in this study of patients with psoriasis, MCS was impaired to a greater extent than PCS at baseline 3…”

Section: Discussionsupporting

confidence: 79%

“…Psoriasis Area and Severity Index (PASI) score and Physician's Global Assessment (PGA)]. However, moderate to severe psoriasis affects patients both physically2, 3 and psychologically,3, 4, 5, 6 leading to major health‐related quality of life (HRQoL) impairment. Therefore, outcome assessments which encompass patient‐reported outcomes (PROs) as well as clinical efficacy are required in order to reflect the complete patient experience.…”

Section: Introductionmentioning

confidence: 99%

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Effect of tofacitinib withdrawal and re‐treatment on patient‐reported outcomes: results from a Phase 3 study in patients with moderate to severe chronic plaque psoriasis

Griffiths

Vender

Sofen

et al. 2016

Acad Dermatol Venereol

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BackgroundTofacitinib is an oral Janus kinase inhibitor being investigated for psoriasis. A Phase 3 withdrawal/re‐treatment study (NCT01186744; OPT Retreatment) showed tofacitinib re‐treatment was effective in patients with chronic plaque psoriasis.ObjectivesTo describe the effects of tofacitinib withdrawal/re‐treatment on health‐related quality of life (HRQoL) and disease symptoms measured by patient‐reported outcomes (PROs).MethodsThe study was divided into initial treatment, treatment withdrawal, and re‐treatment periods. Initial treatment: patients were randomized to receive tofacitinib 5 (n = 331) or 10 mg (n = 335) BID for 24 weeks. Treatment withdrawal: patients who achieved both ≥ 75% reduction in Psoriasis Area and Severity Index (PASI) score from baseline and Physician's Global Assessment of ‘clear’/‘almost clear’ at Week (W)24 received placebo (withdrawal) or the previous dose (continuous treatment). Re‐treatment: at relapse (> 50% loss of W24 PASI response) or at W40, patients received their initial tofacitinib dose. PROs included: Dermatology Life Quality Index (DLQI), Itch Severity Item (ISI), Short Form‐36 (SF‐36) and Patient's Global Assessment (PtGA).ResultsAfter initial treatment with tofacitinib 5 and 10 mg BID, substantial and significant improvements were reported for mean DLQI (baseline: 12.6 and 12.6; W24: 5.1 and 2.6) and ISI (baseline: 6.7 and 6.9; W24: 2.9 and 1.6). Patients continuously treated with tofacitinib 5 and 10 mg BID maintained those improvements through Week 56 (DLQI: 3.0 and 2.1; ISI: 2.3 and 1.4). By W40, patients withdrawn from tofacitinib 5 and 10 mg BID showed worsening in DLQI (5.0 and 6.2) and ISI (3.7 and 4.0) scores; improvements were regained upon re‐treatment (W56, DLQI: 3.4 and 2.4; ISI: 2.2 and 1.6). Similar results were reported for PtGA and SF‐36.ConclusionContinuous tofacitinib treatment provided sustained improvement in HRQoL and disease symptoms. Patients randomized to treatment withdrawal lost initial improvements. Upon re‐treatment, improvements were recaptured to levels comparable to those seen with continuous treatment.

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Section: Discussionsupporting

confidence: 79%

Section: Introductionmentioning

confidence: 99%

Effect of tofacitinib withdrawal and re‐treatment on patient‐reported outcomes: results from a Phase 3 study in patients with moderate to severe chronic plaque psoriasis

Griffiths

Vender

Sofen

et al. 2016

Acad Dermatol Venereol

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“…Based on published results, the magnitude for MCID has been identified as between 5 and 10 for individual subscales of the SF-36 for rheumatoid arthritis, psoriatic arthritis, psoriasis, and SLE (13)(14)(15). The observed change was classified as "no improvement" if the subscale change was Ͻ5, as "marginal change" if the change was Ն5 but Ͻ10, and as "clear improvement" if the change was Ն10.…”

Section: Clinical Assessments Patients With Sle Meeting ն4mentioning

confidence: 99%

Changes in Quality of Life in the First 5 Years of Disease in a Multicenter Cohort of Patients With Systemic Lupus Erythematosus

Urowitz

Gladman

Ibañez

et al. 2014

Arthritis Care & Research

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Objective. The Medical Outcomes Study Short Form 36 (SF-36) is recommended to assess quality of life (QOL) in systemic lupus erythematosus (SLE).The aim of the current study was to assess QOL over time in the first 5 years of a multicenter inception cohort of patients with SLE.Methods. An inception SLE cohort was assembled according to a standardized protocol between 2000 and 2012. In addition to clinical and laboratory assessments, patients completed the SF-36 at yearly intervals. Only patients who had >5 completed QOL questionnaires were included in these analyses. Generalized estimating equation models were run separately for each of the 8 subscales and for the physical and mental component summary scores, adjusting for repeated measures by patients. Results. A total of 495 patients were included. The mean ؎ SD disease duration at the first visit was 5.3 ؎ 4.1 months. The mean ؎ SD age at enrollment was 35.8 ؎ 13.2 years. All 8 subscales and the 2 summary scores showed improvement in the first 2 years from enrollment. Between years 2 and 5, none of the subscales or summary scores showed any change. Minimum clinically important improvement was achieved by 35-56% of the patients and was influenced by demographic and disease factors. Conclusion. Unlike late-stage lupus, where QOL is stable over time, in patients with early disease, all subscales improve in early followup up to 2 years. Therefore, the SF-36 may be a sensitive outcome measure in early disease in patients with SLE.

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“…An improvement of -0.22 in HAQ-DI score is considered to represent MCID in patients with RA and other rheumatologic conditions 4,13,14 . SF-36 is a validated measure of HRQOL or "multidimensional function," and has been used extensively in RCT and longitudinal observational studies evaluating a variety of medical conditions including RA 13,15 , OA 16 , systemic lupus erythematosus 17,18 , psoriatic arthritis 19 , systemic sclerosis 20 , fibromyalgia 21 , and most recently gout 1,3,9,22 . It includes 8 domains: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH), which are aggregated into physical component summary (PCS) and mental component summary (MCS) scores.…”

Section: Methodsmentioning

confidence: 99%

Improved Health-related Quality of Life and Physical Function in Patients with Refractory Chronic Gout Following Treatment with Pegloticase: Evidence from Phase III Randomized Controlled Trials

et al. 2012

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Objective.To assess the efficacy of pegloticase on pain, physical function, and health-related quality of life (HRQOL) in patients with refractory chronic gout.Methods.Subjects in 2 replicate, 6-month, randomized controlled phase III trials received intravenous infusions of pegloticase 8 mg twice monthly (biweekly group), pegloticase alternating with placebo (8-mg monthly group), or placebo. Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA), and pain by visual analog scale were completed at weeks 1 (baseline), 13, 19, and 25. Prespecified pooled analyses of patient-reported outcomes were performed by combining values for each treatment group (biweekly treatment, monthly treatment, and placebo) at Week 25.Results.Of 212 patients enrolled, 157 (74.1%) completed treatment. At entry, mean age was 55.4 years (range 23–89 yrs) and mean plasma uric acid was 9.7 mg/dl; most were male (81.6%) and white (67.5%). Subjects reported an average of 9.8 flares in the previous 18 months. Baseline SF-36 physical component summary (PCS) scores were > 1.5 SD below US normative values. At Week 25, mean changes from baseline in PtGA, pain, HAQ-DI, and PCS scores were statistically significant and exceeded minimum clinically important differences (MCID) in the biweekly treatment group, compared with little to no improvement in placebo group. Statistically significant improvements greater than or equal to MCID were reported in 6 of 8 SF-36 domains. Monthly pegloticase resulted in significantly improved PtGA, HAQ-DI, PCS, and 3 SF-36 domains.Conclusion.Pegloticase therapy resulted in statistically significant and clinically meaningful improvements in PtGA, pain, physical function, and HRQOL.

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Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment

Cited by 128 publications

References 40 publications

Effect of tofacitinib withdrawal and re‐treatment on patient‐reported outcomes: results from a Phase 3 study in patients with moderate to severe chronic plaque psoriasis

Effect of tofacitinib withdrawal and re‐treatment on patient‐reported outcomes: results from a Phase 3 study in patients with moderate to severe chronic plaque psoriasis

Changes in Quality of Life in the First 5 Years of Disease in a Multicenter Cohort of Patients With Systemic Lupus Erythematosus

Improved Health-related Quality of Life and Physical Function in Patients with Refractory Chronic Gout Following Treatment with Pegloticase: Evidence from Phase III Randomized Controlled Trials

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