American college of rheumatology preliminary definition of improvement in rheumatoid arthritis

Felson, David T.; Anderson, Jennifer J.; Boers, Maarten; Bombardier, Claire; Fürst, Daniel E.; Goldsmith, Charles H.; Katz, Linda M.; Lightfoot, Robert W.; Paulus, Harold E.; Strand, Vibeke; Tugwell, Peter; Weinblatt, Michael E.; Williams, H. James; Wolfe, Frederick; Kieszak, Stephanie

doi:10.1002/art.1780380602

Cited by 2,376 publications

(1,498 citation statements)

References 13 publications

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“…However, no effects were found for TJC ( P = 0.60; MD = 1.26; 95% CI: −3.52 to 6.05), SJC ( P = 0.72; MD = −0.37; 95% CI: −2.35 to 1.61), DMS ( P = 0.94; MD = −2.50 min; 95% CI: −67.08 to 62.08), RF ( P = 0.79; SMD = 0.11; 95% CI: −0.70 to 0.92), ESR ( P = 0.54; MD = 5.28 mm/H; 95% CI: −11.62 to 22.17), or CRP ( P = 0.73; SMD = −0.22; 95% CI: −1.47 to 1.03). Only one trial [36] described the results, which were a 20% improvement in RA as defined by ACR (ACR 20) [39], ACR 50, and ACR 70, so we did not pool these results.…”

Section: Resultsmentioning

confidence: 99%

Extracts ofTripterygium wilfordiiHook F in the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis of Randomised Controlled Trials

Liu

Gao

et al. 2013

Evidence-Based Complementary and Alternative Medicine

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Clinical trials have reported the effects of Tripterygium wilfordii Hook F (TwHF) extracts (TEs) in the treatment of rheumatoid arthritis (RA); however, the results have been inconsistent. This meta-analysis is aimed to assess the safety of TEs and their effects on the treatment of RA. Randomised controlled trials (RCTs) comparing the effects of TEs and placebo (PBO) or disease-modifying antirheumatic drugs (DMARDs) in patients with RA were included. Weighted mean differences (MDs) were calculated for net changes by employing fixed-effect or random-effects models. After filtering, ten RCTs (involving 733 participants) were included in this study. The methodological quality of these studies was generally low. Compared with DMARDs, TEs alone produced a mild increase in grip strength (GS) (P = 0.02; standard mean difference (SMD) = 0.81; 95% confidence interval (CI): 0.14 to 1.48). The most common adverse effects (AEs) of TEs were gastrointestinal discomfort, menstruation disorders, and amenorrhea. In conclusion, TEs, as a sort of “herbal DMARD,” could be as effective as synthetic DMARDs in the treatment of RA. However, the efficacy of TEs in treating RA should be further estimated with better designed, fully powered, confirmatory RCTs that apply the American College of Rheumatology (ACR) improvement criteria to evaluate their outcomes.

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Section: Resultsmentioning

confidence: 99%

Extracts ofTripterygium wilfordiiHook F in the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis of Randomised Controlled Trials

Liu

Gao

et al. 2013

Evidence-Based Complementary and Alternative Medicine

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“…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) 11 at week 24. 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.…”

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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“…The primary efficacy end point was a ≥20% improvement in disease activity based on the American College of Rheumatology improvement response criteria (ACR20) 36 compared to placebo at week 12. A secondary end point was to compare the ACR20 response rates between ABT‐122 and adalimumab at week 12, although the study was not powered for these comparisons.…”

Section: Methodsmentioning

confidence: 99%

Phase II Study of ABT‐122, a Tumor Necrosis Factor– and Interleukin‐17A–Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate

Mease

Genovese

Weinblatt

et al. 2018

Arthritis & Rheumatology

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ObjectiveTo investigate the safety and efficacy of ABT‐122, a tumor necrosis factor (TNF)– and interleukin‐17A (IL‐17A)–targeted dual variable domain immunoglobulin, in patients with active psoriatic arthritis (PsA) who have experienced an inadequate response to methotrexate.MethodsPatients (n = 240) were randomized to receive ABT‐122 (120 or 240 mg every week), adalimumab (40 mg every other week), or placebo in a 12‐week double‐blind, parallel‐group study. The primary efficacy end point was the proportion of patients achieving ≥20% improvement in disease activity according to the American College of Rheumatology response criteria (ACR20) at week 12. Secondary and exploratory 12‐week end points included 50% improvement (ACR50) and 70% improvement (ACR70) response rates, and proportion of patients meeting the Psoriasis Area and Severity Index (PASI) response criteria for ≥75% (PASI75) and ≥90% (PASI90) improvement in skin scores among those with ≥3% of their body surface area affected by psoriasis.ResultsIn both ABT‐122 dose groups, ACR20 response rates at week 12 (64.8–75.3%) were superior to that in patients receiving placebo (25.0%) (P < 0.001) but similar to that in patients receiving adalimumab (68.1%). ACR50 and ACR70 response rates were also superior in both ABT‐122 dose groups (36.6–53.4% and 22.5–31.5%, respectively) compared to the placebo group (12.5% and 4.2%, respectively) (P < 0.05). Among eligible patients in the placebo, adalimumab, ABT‐122 120 mg every week, and ABT‐122 240 mg every week treatment groups, PASI75 responses were achieved in 27.3%, 57.6%, 74.4%, and 77.6% of patients, respectively, whereas PASI90 responses were achieved in 18.2%, 45.5%, 48.8%, and 46.9% of patients, respectively. Frequencies of treatment‐emergent adverse events, including infections, were similar across all treatment groups, causing no discontinuations. No serious infections or systemic hypersensitivity reactions were reported with ABT‐122.ConclusionDual neutralization of TNF and IL‐17A with ABT‐122 had efficacy and safety that was similar to, and not broadly differentiated from, that of adalimumab over a 12‐week treatment course in patients with PsA.

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American college of rheumatology preliminary definition of improvement in rheumatoid arthritis

Cited by 2,376 publications

References 13 publications

Extracts ofTripterygium wilfordiiHook F in the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis of Randomised Controlled Trials

Extracts ofTripterygium wilfordiiHook F in the Treatment of Rheumatoid Arthritis: A Systemic Review and Meta-Analysis of Randomised Controlled Trials

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

Phase II Study of ABT‐122, a Tumor Necrosis Factor– and Interleukin‐17A–Targeted Dual Variable Domain Immunoglobulin, in Patients With Psoriatic Arthritis With an Inadequate Response to Methotrexate

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