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Table 2 Ranking of outcomes

From: Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis

Outcome

Rating scale 1–9a (importance of the outcome for decision-making)

Type of outcome

Disease activity/clinical response

 CDAI

9 (critical)

Continuous or binary

 DAS-28 ESR

8.5 (critical)

Continuous or binary

 SDAI

8.5 (critical)

Continuous or binary

 ACR 20

8 (critical)

Binary

 ACR 50

8 (critical)

Binary

 DAS-28 CRP

8 (critical)

Continuous or binary

 ACR-N

7.5 (critical)

Continuous

 ACR 70

6 (important but not critical)

Binary

 EULAR response

5 (important but not critical)

Binary

Safety

 TEAE

9 (critical)

Binary

 Serious TEAE

9 (critical)

Binary

 Death related to treatment

9 (critical)

Binary

 IRRs

9 (critical)

Binary

 Hypersensitivity

9 (critical)

Binary

 Active tuberculosis

9 (critical)

Binary

 Serious infections

9 (critical)

Binary

 Death all causes

8 (critical)

Binary

 Overall discontinuation rate

8.5 (critical)

Binary

 Malignancies

8 (critical)

Binary

 Fatigue

7 (critical)

Binary

Function capacity/quality of life

 HAQ-DI

8.5 (critical)

Continuous

 SF-36 score—physical component summary

8 (critical)

Continuous

 SF-36 score- mental component summary

8 (critical)

Continuous

Structural damage progression

 mTRSS or Sharp/van der Heijde score

5.5 (important but not critical)

Continuous

Immunogenicity

 Incidence of ADAs

5 (important but not critical)

Binary

 NABs—positive

5 (important but not critical)

Binary

  1. ACR The American College of Rheumatology, CRP C-reactive protein level, HAQ-DI Health Assessment Questionnaire—Disability Index, VAS Visual analog scale, SDAI Simplified Disease Activity Score, DA disease activity, CDAI Clinical Disease Activity Score, DAS28-ESR Disease Activity Score in 28 joints based on the erythrocyte sedimentation rate, DAS28-CRP Disease Activity Score in 28 joints, four components based on C-reactive protein, ACR-N The numeric index of the ACR response, EULAR European League Against Rheumatism, SF-36 The Medical Outcomes Study 36-item Short-Form Health Survey, mTRSS Sharp/van der Heijde score, IRRs Infusion-related reactions, TEAE Overall treatment emergent adverse event
  2. aBased on the mean average ranking of two rheumatologists with extensive clinical experience in treating RA patients and a physical therapist with advanced training in evidence synthesis