Patient‐Reported Outcomes and the Association With Clinical Response in Patients With Active Psoriatic Arthritis Treated With Golimumab: Findings Through 2 Years of a Phase III, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Trial

ObjectivesTofacitinib is an oral Janus kinase inhibitor for treatment of psoriatic arthritis (PsA). Patient-reported outcomes (PROs) were evaluated in patients with PsA with inadequate responses to tumour necrosis factor inhibitors (TNFi-IR) in a 6-month, phase III randomised controlled trial (OPAL Beyond [NCT01882439]).MethodsPatients (N=394) received tofacitinib 5 or 10 mg twice daily or placebo (advancing to tofacitinib 5 or 10 mg twice daily at month 3). Least squares mean changes from baseline and percentages of patients reporting improvements ≥minimum clinically important differences and scores ≥normative values were determined 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 (EQ-5D-3L), EQ-VAS and Ankylosing Spondylitis Quality of Life (ASQoL). Nominal p values are without multiple comparison adjustments.ResultsAt month 3, PtGA, Pain, PGJS, SF-36v2 Physical Component Summary (PCS), physical functioning (PF), bodily pain (BP), vitality and social functioning (SF) domains, FACIT-Fatigue Total score, EQ-5D-3L pain/discomfort, EQ-VAS and ASQoL scores exceeded placebo with both tofacitinib doses (role physical [RP] with 10 mg twice daily only; p≤0.05). Patients reporting improvements ≥MCID (%) in PtGA, PGJS, Pain, ASQoL and SF-36v2 PCS, PF, RP, BP, SF (both tofacitinib doses) exceeded placebo (p≤0.05).ConclusionTNFi-IR patients with PsA receiving tofacitinib reported statistically and clinically meaningful improvements in PROs versus placebo over 3 months, which were maintained to month 6. Despite lower baseline scores, these improvements were similar to the csDMARD-IR TNFi-naive OPAL Broaden trial.

Download Full-text

Poster 156 Dysport®, AbobotulinumtoxinA, Improves Disease-Specific Quality of Life in Patients with Cervical Dystonia, as Measured by Patient-Reported Outcomes, in a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

PM&R ◽

10.1016/j.pmrj.2014.08.550 ◽

2014 ◽

Vol 6 (9) ◽

pp. S239

Author(s):

Philippe Picaut ◽

Doctor of Pharmacy ◽

Werner Poewe ◽

Stanislav Vohanka ◽

Jan Ilkowski ◽

...

Keyword(s):

Quality Of Life ◽

Cervical Dystonia ◽

Patient Reported Outcomes ◽

Phase Iii ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

Patient Reported ◽

Disease Specific

Download Full-text

Radiographic Progression Inhibition with Intravenous Golimumab in Psoriatic Arthritis: Week 24 Results of a Phase III, Randomized, Double-blind, Placebo-controlled Trial

The Journal of Rheumatology ◽

10.3899/jrheum.180681 ◽

2019 ◽

Vol 46 (6) ◽

pp. 595-602 ◽

Cited By ~ 3

Author(s):

Arthur Kavanaugh ◽

M. Elaine Husni ◽

Diane D. Harrison ◽

Lilianne Kim ◽

Kim Hung Lo ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Radiographic Progression ◽

Controlled Trial ◽

Phase Iii ◽

Double Blind ◽

Double Blind Placebo ◽

Link Type ◽

Smallest Detectable Change ◽

Total Psa ◽

Hands And Feet

Objective.Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA).Methods.This phase III, randomized, double-blind, placebo-controlled trial (GO-VIBRANT) randomized patients with active PsA to receive IV placebo (n = 239) or IV GOL 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Radiographic progression (controlled secondary endpoint) was evaluated as change from baseline at Week 24 in PsA-modified total Sharp/van der Heijde scores (SvdH). The proportions of patients with a change from baseline at Week 24 in the total PsA-modified SvdH exceeding the smallest detectable change (SDC) or > 0 or 0.5 also were determined.Results.Overall, 474 patients (237/arm) contributed radiographic data. Results obtained from the 2 blinded, independent radiographic readers demonstrated good agreement (total score intraclass correlation coefficients: baseline = 0.93, Week 24 = 0.92, Week 24 change score = 0.73). GOL demonstrated significant inhibition of radiographic progression relative to placebo from baseline to Week 24 (mean changes in PsA-modified total SvdH: −0.36 vs 1.95; treatment difference: −2.32; p < 0.001). At Week 24, smaller proportions of GOL- versus placebo-treated patients demonstrated an increase in the total PsA-modified SvdH score exceeding the SDC (8.0% vs 27.0%, respectively; difference: −19.0%; p < 0.001), > 0 (28.3% vs 57.0%, respectively; difference: −28.7%; p < 0.001), or > 0.5 (18.6% vs 41.8%, respectively; difference: −23.2%; p < 0.001). Results were consistent for erosion and joint space narrowing scores, in hands and feet, and in patients with/without baseline concomitant methotrexate use. Prevention of radiographic progression by GOL was independent of clinical response.Conclusion.IV GOL is significantly better than placebo in inhibiting radiographic progression of structural damage in active PsA. [Clinical trial registration number (www.ClinicalTrials.gov): NCT02181673]

Download Full-text

Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study

Therapeutic Advances in Musculoskeletal Disease ◽

10.1177/1759720x211006964 ◽

2021 ◽

Vol 13 ◽

pp. 1759720X2110069

Author(s):

Yue Yang ◽

Jianhua Xu ◽

Jian Xu ◽

Xingfu Li ◽

Jiankang Hu ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Patient Reported Outcomes ◽

Active Rheumatoid Arthritis ◽

Phase Iii ◽

Inadequate Response ◽

Double Blind ◽

Balance Study ◽

Double Blind Placebo ◽

Patient Reported ◽

Phase Iii Study

Introduction: To assess the effect of baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX). Methods: This was a 52-week, randomized, double-blind, placebo controlled, phase III study in patients with RA who had an inadequate response to MTX. Patients ( n = 290) receiving stable background MTX were randomly assigned (1:1) to receive placebo or baricitinib 4 mg once daily with a primary endpoint at week 12. PROs assessed included Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient’s Global Assessment of Disease Activity, patient’s assessment of pain, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), European Quality of Life-5 Dimensions-5 Level index scores and visual analogue scale, and measures collected in electronic patient daily diaries: duration of morning joint stiffness, Worst Tiredness, and Worst Joint Pain. Treatment comparisons were made with logistic regression and analysis of covariance models for categorical and continuous variables, respectively. Results: Statistically significant ( p ⩽ 0.05) improvements in all PROs were observed in the baricitinib 4 mg group compared to placebo as early as week 1 to week 4; and were sustained to week 24. These improvements were maintained until week 52 for the baricitinib group. A significantly larger proportion of patients met or exceeded the minimum clinically important difference for HAQ-DI (⩾0.22) and FACIT-F (3.56) profiles in the baricitinib group. Conclusion: Baricitinib provided significant improvements in PROs compared to placebo to 52 weeks of treatment in patients with RA who had an inadequate response to MTX. Clinicaltrials.gov identifier: https://clinicaltrials.gov/ct2/show/NCT02265705 ; NCT02265705; RA-BALANCE. Registered 13 October 2014

Download Full-text