Journal List > J Rheum Dis > v.20(6) > 1064077

Son, Jung, Kim, Kim, Lee, Mun, Seo, and Kim: Clinical Characteristics of Korean Rheumatoid Arthritis Patients with Indications for TNF-α Blocker

Abstract

Objective

The aim of this study was to examine clinical characteristics of Korean rheumatoid arthritis (RA) patients with clinically indications for TNF-α blocker, and to compare their clinical parameters with the Korean National Health Insurance reimbursement criteria.

Methods

Data were obtained from a registry of RA patients who visited rheumatology clinics of Hallym University affili-ated hospitals. Among patients who were previously prescribed DMARDs for more than three months, rheumatologists selected patients clinically indicated for TNF-a blocker. The clinical characteristics at the time TNF-α blocker use was deemed indicated were examined. Radiographic damage was quantified by Modified Sharp van der Heijde score in hand and foot simple AP radiograph.

Results

From August 2010 to January 2013, five rheumatologists in four hospitals selected 109 patients clinically indicated for TNF-α blocker. When TNF-α blocker was considered, mean DAS28 was 5.2 (range 2.1∼8.05), mean swollen joint count was 6 (range 0∼22), mean tender joint count was 10.6 (range 0∼28), mean ESR was 43.2 mm/hr (range 1∼140) and mean CRP was 2.5 mg/dL (range 0.1∼18.3). The mean total modified Sharp van der Heijde score was 32.72 (range 0∼240). Eighty one percent of subjects did not have enough active joints to satisfy the Korean National Health Insurance reimbursement standard.

Conclusion

Our results show that patients with clinically indications for TNF-α blocker had a broad range of disease activity and clinical parameters, and the majority did not meet the Korean National Health Insurance reimbursement criteria

References

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Table 1.
Characteristics of Korean rheumatoid arthritis patients eligible for TNF-α blocker (N=109)
Variable  
Age (year) 55.9±13.7
Female, N (%) 87 (79.8)
Disease duration (month) (range) 43.6±91.8 (1∼480)
Treatment duration (month) (range) 18.3±21.3 (3∼96)
RF positive, N (%) 78/96 (81.3)
ACPA positive, N (%) 63/79 (79.7)
Baseline ESR (mm/hr) (range) 50.8±32.4 (2∼123)
Baseline CRP (mg/dL) (range) 3.2±3.5 (0.04∼17.4)

RF: Rheumatoid factor, ACPA: Anti-citrullinated protein antibody, baseline ESR: Erythrocyte sedimentation rate at the start of treatment, baseline CRP: C-reactive protein at the start of treatment. Data are expressed as mean± standard deviation, unless specified otherwise.

Table 2.
Medications used by the study subjects of Table 1 (N=109)
Variable  
Current non biologic DMARDs, N (%)  
  Methotrexate 101 (92.6)
  Leflunomide 55 (50.4)
  Hydroxychloroquine 12 (11)
  Sulfasalazine 6 (5.5)
  Tacrolimus 5 (4.5)
Current biologic DMARDs (%)  
  Etanercept 32 (29.4)
  Adalimumab 28 (25.7)
  Infliximab 12 (11)
Current use of corticosteroid, N (%) 92 (84.4)
Current dose of prednisolone (mg) (mean± SD) 5±3.2
Table 3.
Profiles of DAS28 in study subjects at the time clinically indicated for eligible for TNF-α blocker (N=79)
Variable  
Current DAS28 (range) 5.2±1.28 (2.1∼8.05)
SJC in 28 joint (range) 6±5.3 (0∼22)
TJC in 28 joint (range) 10.6±6.6 (0∼28)
Active joint count in 28 joint (range) 5.1±5 (0∼22)
Active joint count in large joints (range) 1.7±1.6 (0∼7)
ESR (mm/hr) (range) 43.2±29 (1∼140)
CRP (mg/dL) (range) 2.5±3.2 (0.1∼18.3)

DAS28: Disease activity score 28, SJC: swollen joint count, TJC: tender joint count, Active joint count: swollen and tender joint within one joint, large joints∗: both shoulder, hip, knee, ankle, elbow, wrist, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein. Data are expressed as mean± standard deviation, unless specified otherwise.

Table 4.
The Profile of Radiographic score measured by van der Heijde's modification score within 1 year at the time clinically indicated for TNF-α blocker
Variable  
Hands erosions (range) (N=77) 8.06±18.73 (0∼109)
Hands joint space narrowing (range) (N=77) 17.4±23.62 (0∼103)
Hands total score(range) (N=77) 25.46±39.84 (0∼212)
Feet erosions (range) (N=56) 4.96±11.03 (0∼69)
Feet joint space narrowing (range) (N=56) 3.75±7.11 (0∼38)
Feet total score (range) (N=56) 8.71±16.91 (0∼87)
Hands and feet erosions (range) (N=53) 12.11±22.73 (0∼125)
Hands and feet joint space 20.64±26.61 (0∼115)
narrowing (range) (N=53)  
Hands and feet total score (range) (N=53) 32.75±47.1 (0∼240)

Data are expressed as mean± standard deviation, unless specified otherwise.

Table 5.
Reasons for failing the Korean National Health Insurance reimbursement criteria at the time clinically indicated for TNF-α blocker (N=109)
Failed criteria Number (%)
Acute phase reactant (ESR or CRP) 27/109 (24.8)
Active joint count 64/79 (81)
Previous treatment Hx 21/109 (19.3)

Acute phase reactant

: ESR≥28 mm/hr or CRP≥2 mg/dL, Active joint count

: more than 20 total active joint counts or total 6 active joint counts with more 4 active joint count in large joints, Previous treatment Hx

: inadequate control despite treatment for at least 3 months respectively with 2 more DMARDs

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