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

Strand, Vibeke; Vlam, Kurt de; Covarrubias-Cobos, Jose A; Mease, Philip J.; Gladman, Dafna D.; Graham, Daniela; Wang, Cunshan; Cappelleri, Joseph C.; Hendrikx, Thijs; Hsu, Ming‐Ann

doi:10.1136/rmdopen-2018-000806

Cited by 56 publications

(58 citation statements)

References 41 publications

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“…Additional pre-specified secondary endpoints of Dactylitis Severity Score (DSS), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) were in the same direction as the primary endpoints but could not be assessed for significance due to hierarchical statistical testing of secondary endpoints. 11,18 Radiographs of the hands and feet were assessed at baseline and 12 months using the van der Heijde-modified Total Sharp Score (mTSS). At 12 months, 91-98% of patients across all treatment groups met the radiographic criteria for nonprogression of joint damage, defined as a change in mTSS of ≤0.5, ≤0, or ≤0.66 from baseline.…”

Section: Psoriatic Arthritis Clinical Trialsmentioning

confidence: 99%

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

Ly¹,

Beck²,

Smith³

et al. 2019

PTT

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Tofacitinib is an oral Janus kinase inhibitor approved for the treatment of psoriatic arthritis (PsA). It provides an alternative option for patients who have had an inadequate response and tolerance to other disease modifying antirheumatic drugs (DMARDs). It has demonstrated comparable efficacy to biologics, is effective in the management of treatment resistant disease, and is reported to improve enthesitis, dactylitis, and radiographic progression. Tofacitinib is also associated with an increased risk of serious infections, malignancy, and laboratory abnormalities. There is currently a large armamentarium of therapies for psoriatic arthritis, and choosing among treatments can be challenging. Due to this wide selection, a thorough assessment of psoriatic disease phenotype, patient preference, disease presentation, and comorbidities is critical. This review addresses key considerations in patient selection for the treatment of PsA with tofacitinib.

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Section: Psoriatic Arthritis Clinical Trialsmentioning

confidence: 99%

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

Ly¹,

Beck²,

Smith³

et al. 2019

PTT

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“…Tofacitinib is an oral JAK inhibitor for the treatment of RA and PsA, and is under investigation for the treatment of AS. The efficacy of tofacitinib in improving patient-reported outcomes (PROs), including pain, has been demonstrated in PRO components of phase III RCTs in patients with RA22–26 and PsA,27 28 and in a phase II RCT in patients with AS 29…”

Section: Introductionmentioning

confidence: 99%

Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

et al. 2020

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ObjectiveTo describe the efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) in a post-hoc analysis of randomised controlled trials.MethodsData were collected from patients in seven tofacitinib studies: six phase III (four RA, two PsA) and one phase II study (AS), and grouped into five analysis populations based on rheumatic disease diagnosis and category of prior inadequate response (IR) to treatment: conventional synthetic disease-modifying antirheumatic drugs-IR (RA and PsA), tumour necrosis factor inhibitors-IR (RA and PsA), or non-steroidal anti-inflammatory drugs-IR (AS). Only patients who received tofacitinib 5 or 10 mg twice daily or placebo were included. Pain assessments included: Patient’s Assessment of Arthritis Pain, Short-Form Health Survey 36v2 Question (Q)7 and Bodily Pain domain, Ankylosing Spondylitis Quality of Life Q9 and Q14, EuroQol Five Dimensions Pain/Discomfort dimension and Bath Ankylosing Spondylitis Disease Activity Index Q2 and Q3. Data were reported to month 6 (placebo to month 3) in the RA and PsA populations, and week 12 (tofacitinib and placebo) in the AS population.ResultsOverall, 3330 patients were included in this analysis. In the RA and PsA populations, pain improvements in tofacitinib-treated patients compared with placebo were observed at the earliest time point assessed and at month 3 (maintained to month 6). In the AS population, pain improvements compared with placebo were observed at week 12.ConclusionTofacitinib was associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic musculoskeletal diseases.

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“…This is consistent with the baseline characteristics reported from other biological or targeted synthetic disease-modifying antirheumatic drug clinical trials. While different measures of fatigue were used across studies, a trial using the fatigue assessment scale (range 0–10; higher score=greater fatigue) reported baseline scores of 5.8–6.3 across treatment groups,36 trials reporting scores from the FACIT-fatigue (0–52; higher score=less fatigue) reported scores of 24.5–30.8 across treatment groups,37–40 and a trial using a fatigue 0–100 VAS (higher score=greater fatigue) reported scores of 54.7–55.9 across treatment groups 41…”

Section: Discussionmentioning

confidence: 99%

Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

et al. 2020

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ObjectivesThis study assessed the psychometric properties of the fatigue numeric rating scale (NRS) and sought to establish values for clinically meaningful change (responder definition).MethodsUsing disease-specific clinician-reported and patient-reported data from two randomised clinical trials of patients with psoriatic arthritis (PsA), the fatigue NRS was evaluated for test–retest reliability, construct validity and responsiveness. A responder definition was also explored using anchor-based and distribution-based methods.ResultsTest–retest reliability analyses supported the reproducibility of the fatigue NRS in patients with PsA (intraclass correlation coefficient=0.829). Mean (SD) values at baseline and week 2 were 5.7 (2.2) and 5.7 (2.4), respectively. Supporting construct validity of the fatigue NRS, moderate-to-large correlations with other assessments measuring similar concepts as measured by Sackett’s conventions were demonstrated. Fatigue severity was reduced when the underlying disease activity was improved and reductions remained consistent at week 12 and 24. A 3-point improvement was identified as being optimal for demonstrating a level of clinically meaningful improvement in fatigue NRS after 12–24 weeks of treatment.ConclusionsFatigue NRS is a valid and responsive patient-reported outcome instrument for use in patients with PsA. The established psychometric properties from this study support the use of fatigue NRS in clinical trials and in routine clinical practice. Robust validation of reliability for use in routine clinical practice in treating patients with active PsA in less active disease states and other more diverse ethnic groups is needed.

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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

Cited by 56 publications

References 41 publications

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis

Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis

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