scholarly journals Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial

2006 ◽  
Vol 66 (2) ◽  
pp. 163-168 ◽  
Author(s):  
D D Gladman ◽  
P J Mease ◽  
M A Cifaldi ◽  
R J Perdok ◽  
E Sasso ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Functional Impairment ◽  
Patient Reported Outcomes ◽  
Patient Reported

scholarly journals Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial

2018 ◽  
Vol 20 (1) ◽  
Author(s):  
Vibeke Strand ◽  
Evo Alemao ◽  
Thomas Lehman ◽  
Alyssa Johnsen ◽  
Subhashis Banerjee ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Patient Reported Outcomes ◽  
Phase 3 ◽  
Patient Reported

scholarly journals Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden—a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000806 ◽  
Author(s):  
Vibeke Strand ◽  
Kurt de Vlam ◽  
Jose A Covarrubias-Cobos ◽  
Philip J Mease ◽  
Dafna D Gladman ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Janus Kinase ◽  
Phase Iii ◽  
Placebo Patient ◽  
Pain Patient ◽  
Inadequate Response ◽  
Patient Reported ◽  
Disease Modifying

ObjectivesTofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). We evaluated patient-reported outcomes (PROs) in patients with PsA refractory to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and tumour necrosis factor inhibitor-naïve in a 12-month, phase III randomised controlled trial (OPAL Broaden [NCT01877668]).MethodsPatients (N=422) received tofacitinib 5 mg or 10 mg twice daily, adalimumab 40 mg subcutaneously every 2 weeks or placebo advancing to tofacitinib 5 mg or 10 mg twice daily at month 3. Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences (MCID); and scores ≥normative values in: Patient Global Assessment of disease activity (PtGA), Pain, Patient Global Joint and Skin Assessment (PGJS), Short Form-36 Health Survey version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQol 5-Dimensions-3-level questionnaire (EQ-5D-3L) and Ankylosing Spondylitis Quality of Life (ASQoL) were determined. Nominal p values were cited without multiple comparison adjustments.ResultsAt month 3, PtGA, Pain, PGJS, FACIT-Fatigue, EQ-5D-3L, ASQoL and SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP) and vitality domain scores exceeded placebo with both tofacitinib doses (p≤0.05); SF-36v2 social functioning with 5 mg twice daily (p≤0.05). Percentages reporting improvements ≥MCID in PtGA, Pain, PGJS, FACIT-Fatigue, ASQoL and SF-36v2 PCS, PF, BP and general health scores exceeded placebo with both tofacitinib doses (p≤0.05) and were similar with adalimumab.ConclusioncsDMARD-IR patients with active PsA reported statistically and clinically meaningful improvements in PROs with tofacitinib compared with placebo at Month 3.

Identification of Cutpoints for Acceptable Health Status and Important Improvement in Patient-Reported Outcomes, in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

2009 ◽  
Vol 37 (1) ◽  
pp. 26-31 ◽  
Author(s):  
MARIA KNOPH KVAMME ◽  
IVAR SØNBØ KRISTIANSEN ◽  
ELISABETH LIE ◽  
TORE KRISTIAN KVIEN
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Health Status ◽  
Ankylosing Spondylitis ◽  
Patient Reported Outcomes ◽  
Classification Systems ◽  
Operating Characteristics ◽  
Percentile Method ◽  
Important Improvement ◽  
Patient Reported

Objective.To identify cutpoints reflecting Patient Acceptable Symptom State (PASS) and Minimal Clinically Important Improvement (MCII) in patient-reported multi-attribute health status classification systems and health status measurements among patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA).Methods.We identified patients with RA, AS, and PsA from the Norwegian disease-modifying antirheumatic drug (DMARD) register (NOR-DMARD). The patients (n = 4225) had started with DMARD and responded to the PASS and MCII anchoring questions at the 3-month followup examination. Receiver operating characteristics (ROC) curves with 80% specificity and the 75th percentile approach were used to identify PASS and MCII cutpoints in the EuroQol-5 Dimensions (EQ-5D) and the Short-Form-6 Dimensions (SF-6D) indexes, but also in other patient-reported outcomes (joint pain and patient global visual analog scale and Modified Health Assessment Questionnaire).Results.The PASS cutpoints estimated with 80% specificity were around 0.70 in EQ-5D in all diseases and around 0.65 in SF-6D. The cutpoints were around 0.65 and 0.60, respectively, when the 75th percentile approach was used. The MCII cutpoints assessed by 80% specificity varied from 0.10 to 0.19 in EQ-5D and from 0.07 to 0.10 in SF-6D.Conclusion.The cutpoints for PASS in EQ-5D and SF-6D indicate that PASS corresponds to a health-related quality of life that is far from perfect health. Somewhat different cutpoints were identified for both PASS and MCII with 80% specificity versus the 75th percentile method.

scholarly journals Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naïve patients with active psoriatic arthritis (SPIRIT-P1)

Rheumatology ◽  
2018 ◽  
Vol 57 (10) ◽  
pp. 1777-1788 ◽  
Author(s):  
Alice B Gottlieb ◽  
Vibeke Strand ◽  
Mitsumasa Kishimoto ◽  
Philip Mease ◽  
Diamant Thaçi ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Patient Reported Outcomes ◽  
Patient Reported
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