Modified disease activity scores that include twenty-eight-joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritis

Prevoo, M.L.L.; Hof, M.A. van ‘t; Kuper, H.H.; Leeuwen, M.A. van; Putte, L.B.A. van de; Riel, P.L.C.M. van

doi:10.1002/art.1780380107

Cited by 5,405 publications

(3,692 citation statements)

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“…PASI 75 response was achieved by approximately half of patients with PsA at weeks 16 and 24. As shown in Figure 3, mean DAS28‐ESR and DAS28‐CRP values at baseline were 4.4 and 3.5, respectively, which represent moderate disease activity (≥3.2 to ≤5.1) according to the American College of Rheumatology (ACR) thresholds for DAS28 13. By 4 weeks of treatment, DAS28‐ESR and DAS28‐CRP values had decreased to below the ACR cut‐off for low disease activity (3.2), and by 16 and 24 weeks, mean DAS28 values had decreased to below the ACR cut‐off for disease remission (<2.6).…”

Section: Resultsmentioning

confidence: 99%

“…First, disease activity was assessed by the 28‐joint Disease Activity Score (DAS28) at weeks 4, 16 and 24. DAS28 was calculated using C‐reactive protein (DAS28‐CRP) and erythrocyte sedimentation rate (DAS28‐ESR), with a score of more than 5.1 indicating high/severe disease activity, 3.2 or more to 5.1 or less indicating moderate disease activity, 2.6 or more to less than 3.2 indicating low/minimal disease activity, and less than 2.6 indicating remission 13. Second, pain was evaluated using a visual analog scale (VAS) ranging from 0 (no pain) to 100 (pain as bad as it could be) at weeks 4, 16 and 24.…”

Section: Methodsmentioning

confidence: 99%

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Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study

Asahina

Torii

Ohtsuki

et al. 2016

The Journal of Dermatology

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The safety and efficacy of adalimumab were evaluated over 24 weeks in Japanese patients with psoriasis in routine clinical practice. In this multicenter, observational, open‐label, postmarketing study, primary efficacy measures included the Psoriasis Area and Severity Index (PASI) and the Dermatology Life Quality Index (DLQI) in all patients with psoriasis. In patients with psoriatic arthritis (PsA), the 28‐joint Disease Activity Score (DAS28) and the visual analog scale (VAS) pain were also evaluated. Safety was assessed based on the frequency of adverse drug reactions (ADR). Among patients with psoriasis evaluated for efficacy (n = 604), significant improvements from baseline were observed in mean PASI and DLQI scores at weeks 16 and 24 (all P < 0.0001). Furthermore, in psoriasis patients without PsA, the PASI 75/90 response rates were 55.9%/28.4% at week 16 (n = 306) and 65.6%/43.3% at week 24 (n = 270), respectively. In patients with PsA evaluable for effectiveness, significant improvements from baseline were observed in PASI, DAS28 erythrocyte sedimentation rate, DAS28 C‐reactive protein and VAS pain at weeks 16 and 24 (all P < 0.0001). ADR and serious ADR were reported by 26.1% and 3.3%, respectively, of 731 safety evaluable patients with psoriasis; no unexpected safety findings were noted. The safety profile and effectiveness of adalimumab for the treatment of psoriasis in a routine clinical setting were as expected in Japanese patients.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study

Asahina

Torii

Ohtsuki

et al. 2016

The Journal of Dermatology

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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

339

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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“…Disease activity was assessed by the DAS28, a validated instrument in which higher scores indicate greater disease activity 8, 9. The self‐administered Funktionsfragebogen Hannover (FFbH) patient questionnaire was used to assess patient function on a scale of 0 (total loss of functional capacity) to 100 (maximal functional capacity) units 10; the FFbH score indicates the remaining percentage of function.…”

Section: Methodsmentioning

confidence: 99%

Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis

Scharbatke

Behrens

Schmalzing

et al. 2016

Arthritis Care & Research

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ObjectiveTo use statistical methods to establish a threshold for individual response in patient‐reported outcomes (PROs) in patients with rheumatoid arthritis.MethodsWe used an analysis of variance model in patients on stable therapy (discovery cohort) to establish critical differences (dcrit) for the minimum change associated with a significant individual patient response (beyond normal variation) in the PRO measures of pain (0–10), fatigue (0–10), and function (Funktionsfragebogen Hannover questionnaire; 0–100). We then evaluated PRO responses in patients initiating adalimumab in a noninterventional study (treatment cohort).ResultsIn the discovery cohort (n = 700), PROs showed excellent long‐term retest reliability. The minimum change that exceeded random fluctuation was conservatively determined to be 3 points for pain, 4 points for fatigue, and 16 points for function. In the treatment cohort (n = 2,788), 1,483 patients (53.2%) achieved a significant individual therapeutic response as assessed by Disease Activity Score in 28 joints (DAS28)–dcrit (≥1.8 points) after 12 months of adalimumab treatment; 68.5% of patients with a DAS28‐dcrit response achieved a significant improvement in pain, whereas approximately 40% achieved significant improvements in fatigue or function. Significant improvements in all 3 PROs occurred in 22.7% of patients; 22.8% did not have any significant PRO responses. In contrast, significant improvements in all 3 PROs occurred in only 4.4% of 1,305 patients who did not achieve a DAS28‐dcrit response at month 12, and 59.1% did not achieve any significant PRO responses.ConclusionThe establishment of critical differences in PROs distinguishes true responses from random variation and provides insights into appropriate patient management.

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Modified disease activity scores that include twenty-eight-joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritis

Cited by 5,405 publications

References 12 publications

Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study

Safety and efficacy of adalimumab treatment in Japanese patients with psoriasis: Results of SALSA study

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

Association of Improvement in Pain With Therapeutic Response as Determined by Individual Improvement Criteria in Patients With Rheumatoid Arthritis

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