Measurement of patient outcome in arthritis

Fries, James F.; Spitz, Patricia W.; Kraines, R. Guy; Holman, Halsted R.

doi:10.1002/art.1780230202

Cited by 3,920 publications

(2,483 citation statements)

References 12 publications

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“…The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (ACR20 response) (8) at week 14. An ACR20 response was defined as Ն20% improvement in the swollen joint count (66 joints), the tender joint count (68 joints), and at least 3 of the following 5 assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function using the Health Assessment Questionnaire (HAQ) (9), and the C-reactive protein (CRP) level. ACR50 and ACR70 responses were defined similarly, using Ն50% and Ն70% improvements, respectively.…”

Section: Methodsmentioning

confidence: 99%

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Kavanaugh¹,

McInnes²,

Mease³

et al. 2009

Arthritis & Rheumatism

564

489

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Objective. To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods. Adult patients withPsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n ‫؍‬ 113), golimumab 50 mg (n ‫؍‬ 146), or golimumab 100 mg (n ‫؍‬ 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic nail disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index).Results. At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric nail disease, and the PsAClinicalTrials.gov identifier: NCT00265096.

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Section: Methodsmentioning

confidence: 99%

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Kavanaugh¹,

McInnes²,

Mease³

et al. 2009

Arthritis & Rheumatism

564

489

View full text Add to dashboard Cite

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“…Major secondary end points assessed at week 24 included superiority comparisons of baricitinib monotherapy or baricitinib plus MTX to MTX monotherapy based on the ACR20 response, Health Assessment Questionnaire disability index (HAQ DI) 12, 13, Simplified Disease Activity Index (SDAI) remission (score of ≤3.3) 14, Disease Activity Score in 28 joints 15 based on C‐reactive protein level (DAS28‐CRP) 16, and modified Sharp/van der Heijde score (SHS) 17. Radiographs were scored centrally by 2 independent readers with adjudication by a third reader, if needed.…”

Section: Methodsmentioning

confidence: 99%

Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease‐Modifying Antirheumatic Drug Treatment

Fleischmann

Schiff

Heijde

et al. 2017

Arthritis & Rheumatology

358

306

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ObjectiveWe undertook this phase III study to evaluate baricitinib, an orally administered JAK‐1/JAK‐2 inhibitor, as monotherapy or combined with methotrexate (MTX) compared to MTX monotherapy in patients with active rheumatoid arthritis (RA) who had received no or minimal conventional synthetic disease‐modifying antirheumatic drugs (DMARDs) and who were naive to biologic DMARDs.MethodsA total of 588 patients were randomized 4:3:4 to receive MTX monotherapy (once weekly), baricitinib monotherapy (4 mg once daily), or the combination of baricitinib and MTX for 52 weeks. The primary end point assessment was a noninferiority comparison of baricitinib monotherapy to MTX monotherapy based on the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 24.ResultsThe study met its primary objective. Moreover, baricitinib monotherapy was found to be superior to MTX monotherapy at week 24, with a higher ACR20 response rate (77% versus 62%; P ≤ 0.01). Similar results were observed for combination therapy. Compared to MTX monotherapy, significant improvements in disease activity and physical function were observed for both baricitinib groups as early as week 1. Radiographic progression was reduced in both baricitinib groups compared to MTX monotherapy; the difference was statistically significant for baricitinib plus MTX. The rates of serious adverse events (AEs) were similar across treatment groups, while rates of some treatment‐emergent AEs, including infections, were increased with baricitinib plus MTX. Three deaths were reported, all occurring in the MTX monotherapy group. Malignancies, including nonmelanoma skin cancer, were reported in 1 patient receiving MTX monotherapy, 1 receiving baricitinib monotherapy, and 4 receiving baricitinib plus MTX.ConclusionBaricitinib alone or in combination with MTX demonstrated superior efficacy with acceptable safety compared to MTX monotherapy as initial therapy for patients with active RA.

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“…For the purpose of these post‐hoc analyses, and as validated by Coates and Helliwell 5, MDA was defined as the presence of at least 5 of the following 7 PsA outcome measures: swollen joint count ≤1 of 66 evaluated; tender joint count ≤1 of 68 evaluated; Psoriasis Area and Severity Index (PASI) ≤1 (range 0–72)11; patient pain visual analog scale (VAS) score ≤15 (range 0–100); patient global assessment of disease activity VAS score of ≤20 (range 0–100); Health Assessment Questionnaire disability index (HAQ DI) score ≤0.5 (range 0–3)12, 13; and tender enthesis points ≤1.…”

Section: Methodsmentioning

confidence: 99%

Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study

Kavanaugh

Heijde

Beutler

et al. 2016

Arthritis Care & Research

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ObjectiveTo evaluate long‐term outcomes in psoriatic arthritis (PsA) patients who achieved or did not achieve minimal disease activity (MDA) through 5 years of golimumab treatment in the GO‐REVEAL trial.MethodsThe GO‐REVEAL trial was a phase III, randomized, double‐blind trial with placebo‐control through week 24 followed by an open‐label extension of golimumab 50/100 mg treatment up to 5 years. In these post‐hoc analyses, MDA was defined by the presence of ≥5 of 7 PsA outcome measures (≤1 swollen joint, ≤1 tender joint, Psoriasis Area and Severity Index [PASI] ≤1, patient pain score ≤15, patient global disease activity score ≤20 [range 0–100], Health Assessment Questionnaire disability index [HAQ DI] ≤0.5, and ≤1 tender enthesis point).ResultsTreatment with golimumab yielded significantly higher MDA response rates versus patients randomized to placebo at week 14 (23.5% versus 1.0%; P < 0.0001), week 24 (28.1% versus 7.7%; P < 0.0001), and week 52 (42.4% versus 30.2%; P = 0.037). MDA was achieved at least once by ∼50% of golimumab‐treated patients overall. Irrespective of treatment randomization, achievement of MDA at ≥3 and ≥4 consecutive visits was associated with significantly less radiographic progression and more improvement in MDA components allowing specific assessment of physical function (HAQ DI) and overall disease activity (patient global assessment of disease activity) at week 256 versus patients not achieving MDA. Logistic regression analyses indicated that a 1‐unit higher baseline HAQ DI score yielded a significantly lower likelihood of achieving MDA at ≥3 (odds ratio 0.514 [95% confidence interval 0.321–0.824]; P = 0.006) and ≥4 (odds ratio 0.480 [95% confidence interval 0.290–0.795]; P = 0.004) consecutive visits.ConclusionAmong golimumab‐treated PsA patients, better long‐term functional improvement, patient global assessment, and radiographic outcomes were observed when patients achieved persistent MDA.

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Measurement of patient outcome in arthritis

Cited by 3,920 publications

References 12 publications

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Golimumab, a new human tumor necrosis factor α antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty‐four–week efficacy and safety results of a randomized, placebo‐controlled study

Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease‐Modifying Antirheumatic Drug Treatment

Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study

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