Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.

The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.

The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).

The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).

A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.

Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).

DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.

The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.

The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = >=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = >=50% of the intraarticular area filled with color signals; higher scores= more severe disease.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.