Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

Maksymowych, Walter P.; Mallon, Catherine; Morrow, Sharon; Shojania, Kamran; Olszynski, Wojciech P.; Wong, Robert; Sampalis, John S.; Conner‐Spady, Barbara

doi:10.1136/ard.2007.084244

Cited by 223 publications

(178 citation statements)

References 15 publications

Supporting

Mentioning

169

Contrasting

Unclassified

Order By: Relevance

“…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. Additional efficacy end points included ACR20 response rates as well as ≥50% improvement (ACR50) and ≥70% improvement (ACR70) response rates at each postbaseline assessment (weeks 2, 4, 8, and 12); disease control, defined for this study as a score of <3.2 or <2.6 on the Disease Activity Score in 28 joints using hsCRP level (DAS28‐hsCRP) 37 at week 12; mean decrease from baseline in the DAS28‐hsCRP of at least 1.2 at week 12; mean changes from baseline in the DAS28‐hsCRP at each postbaseline assessment; improvement in the Psoriasis Area and Severity Index (PASI) skin scores by ≥50% (PASI50), ≥75% (PASI75), and ≥90% (PASI90) (38) at week 12 in patients who had ≥3% of their body surface area affected by psoriasis at baseline; responses on the Stanford Health Assessment Questionnaire modified for the spondyloarthritides (HAQ‐S) 39, defined empirically in this study as an improvement (decrease) from baseline of at least 0.5 points; mean changes in the HAQ‐S score at each postbaseline assessment; mean changes from baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index 40 at weeks 4, 8, and 12; and scores of 0 or 1 (full scale 0–6) on the physician's global assessment of psoriasis at week 12.…”

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

View full text Add to dashboard Cite

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.

show abstract

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

View full text Add to dashboard Cite

show abstract

“…The resulting assessments were used for the calculation of the LEI (score 0-6, based on 3 bilateral sites 11 ), the SPARCC Enthesitis Index (score 0-16, based on 9 bilateral sites; for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity 12 ), and the MASES (score 0-13, based on 6 bilateral sites and a single spinous process 13 ; Figure 1). …”

Section: Methodsmentioning

confidence: 99%

Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab

Mease¹,

Bosch²,

Sieper³

et al. 2017

J Rheumatol

View full text Add to dashboard Cite

Objective.To evaluate the validity of enthesitis indices in patients with peripheral spondyloarthritis (pSpA).Methods.The ABILITY-2 study evaluated the efficacy of adalimumab (ADA) versus placebo (PBO) in patients with active pSpA over 12 weeks. Patients received open-label ADA for an additional 144 weeks. Twenty-nine enthesitis sites used in 3 enthesitis scoring systems [Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index, Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)] were assessed; discriminatory capacity and treatment response at Week 12 were calculated by standardized mean difference (SMD) and Guyatt’s effect size (ES). Sites showing resolution or new-onset enthesitis from baseline to Week 12 were analyzed.Results.Overall, 165 patients (ADA, n = 84; PBO, n = 81) were randomized; 143 had ≥ 1 enthesitis site at baseline. The LEI (SMD −0.73, ES −1.07) and SPARCC (SMD −0.56, ES −0.99) enthesitis indices showed higher discriminatory ability and treatment response than MASES (SMD −0.32, ES −0.81). At Week 12, among sites that were positive at baseline, significantly more (p < 0.05) showed resolution among patients treated with ADA versus PBO in the Achilles tendon (60.4% and 36.5%, respectively), medial epicondyle (73.2%, 48.7%), lateral epicondyle (80.6%, 52.8%), and iliac crest (73.5%, 47.2%). Among negative sites at baseline, significantly less (p < 0.05) new-onset enthesitis was observed with ADA versus PBO for Achilles tendon (3.6% and 10.9%, respectively), greater trochanter (3.4%, 14.4%), lateral epicondyle humerus (4.7%, 15.1%), medial femoral condyle (1.6%, 9.2%), and quadriceps insertion superior patella (1.5%, 7.0%).Conclusion.The LEI and SPARCC enthesitis indices showed better discriminatory capacity and treatment response in patients with pSpA versus MASES, likely because these indices contain more peripheral sites. Trial registration number: ClinicalTrials.govNCT01064856.

show abstract

“…Assessment tools for enthesitis in PsA are often originally developed for use in other spondyloarthropathies, such as ankylosing spondylitis. Other measures of enthesitis, such as the Leeds and Spondyloarthritis Research Consortium of Canada Enthesitis Indices, had not been published at the time the ADEPT trial was designed 26,27 . The original MDA is open to any enthesitis count up to a maximum of 13 entheseal points 13 .…”

Section: Rheumatologymentioning

confidence: 99%

Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

et al. 2013

View full text Add to dashboard Cite

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.

show abstract

Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index

Abstract: AS patients with enthesitis constitute a more severe subset of disease, and the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index is feasible and reliable for measurement of this condition. Discrimination requires further study in larger trials.

Cited by 223 publications

References 15 publications

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

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

Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab

Application and Modifications of Minimal Disease Activity Measures for Patients with Psoriatic Arthritis Treated with Adalimumab: Subanalyses of ADEPT

Contact Info

Product

Resources

About