Baseline patient demographics, disease characteristics and prior medical history
| Parameter . | Safety population (n = 337, unless stated otherwise) . |
|---|---|
| Demographics | |
| Age, mean (s.d.), years | 57.58 (11.78) |
| Weight, mean (s.d.), kg | 72.8 (16.78) |
| Patient >65 years of age, n (%) | 94 (27.89) |
| Male/female, n (%) | 50/287 (14.84/85.16) |
| Disease characteristics | |
| DAS28 ESR at baseline, mean (s.d.) (n = 281) | 5.79 (0.97) |
| DAS28 CRP at baseline, mean (s.d.) (n = 52) | 5.8 (0.97) |
| CDAI at baseline, mean (s.d.) (n = 234) | 32.36 (12.54) |
| Treatment history before study enrolment or at baseline | |
| MTX (n = 333) | |
| MTX stopped >1 week before TCZ start, n (%) | 114 (34.23) |
| No MTX, n (%) | 219 (65.77) |
| MTX dosage, mean (s.d.), mg/week (n=114) | 15.48 (4.411) |
| Reason for no MTX use, n (%) (n = 219) | |
| Non-adherence | 19 (8.68) |
| Intolerance or contraindications | 195 (89.04) |
| Other | 5 (2.28) |
| Conventional synthetic DMARDs (other than MTX) (n = 333) | |
| Conventional synthetic DMARD at enrolment, n (%) | 185 (55.56) |
| Conventional synthetic DMARD continued after TCZ initiation, n (%) | 119 (64.32) |
| Biologic treatment (n = 333) | |
| One biologic product (2L), n (%) | 138 (41.44) |
| Two or more biologic products (2L+), n (%) | 76 (22.82) |
| No biologic products (1L), n (%) | 119 (35.74) |
| CSs (n = 333) | |
| CS treatment at baseline, n (%) | 160 (48.05) |
| CS dosage at baseline, mean (s.d.), mg/month | 171.6 (107.4) |
| Parameter . | Safety population (n = 337, unless stated otherwise) . |
|---|---|
| Demographics | |
| Age, mean (s.d.), years | 57.58 (11.78) |
| Weight, mean (s.d.), kg | 72.8 (16.78) |
| Patient >65 years of age, n (%) | 94 (27.89) |
| Male/female, n (%) | 50/287 (14.84/85.16) |
| Disease characteristics | |
| DAS28 ESR at baseline, mean (s.d.) (n = 281) | 5.79 (0.97) |
| DAS28 CRP at baseline, mean (s.d.) (n = 52) | 5.8 (0.97) |
| CDAI at baseline, mean (s.d.) (n = 234) | 32.36 (12.54) |
| Treatment history before study enrolment or at baseline | |
| MTX (n = 333) | |
| MTX stopped >1 week before TCZ start, n (%) | 114 (34.23) |
| No MTX, n (%) | 219 (65.77) |
| MTX dosage, mean (s.d.), mg/week (n=114) | 15.48 (4.411) |
| Reason for no MTX use, n (%) (n = 219) | |
| Non-adherence | 19 (8.68) |
| Intolerance or contraindications | 195 (89.04) |
| Other | 5 (2.28) |
| Conventional synthetic DMARDs (other than MTX) (n = 333) | |
| Conventional synthetic DMARD at enrolment, n (%) | 185 (55.56) |
| Conventional synthetic DMARD continued after TCZ initiation, n (%) | 119 (64.32) |
| Biologic treatment (n = 333) | |
| One biologic product (2L), n (%) | 138 (41.44) |
| Two or more biologic products (2L+), n (%) | 76 (22.82) |
| No biologic products (1L), n (%) | 119 (35.74) |
| CSs (n = 333) | |
| CS treatment at baseline, n (%) | 160 (48.05) |
| CS dosage at baseline, mean (s.d.), mg/month | 171.6 (107.4) |
CDAI: clinical disease activity index; n: number of patients in group; TCZ: tocilizumab. Defined subgroups: 1L: first line = tocilizumab after failing DMARDs before enrolment; 2L: second line = tocilizumab after failing one biologic before enrolment; 2L+: third line = tocilizumab after failing two or more biologics before enrolment.
Baseline patient demographics, disease characteristics and prior medical history
| Parameter . | Safety population (n = 337, unless stated otherwise) . |
|---|---|
| Demographics | |
| Age, mean (s.d.), years | 57.58 (11.78) |
| Weight, mean (s.d.), kg | 72.8 (16.78) |
| Patient >65 years of age, n (%) | 94 (27.89) |
| Male/female, n (%) | 50/287 (14.84/85.16) |
| Disease characteristics | |
| DAS28 ESR at baseline, mean (s.d.) (n = 281) | 5.79 (0.97) |
| DAS28 CRP at baseline, mean (s.d.) (n = 52) | 5.8 (0.97) |
| CDAI at baseline, mean (s.d.) (n = 234) | 32.36 (12.54) |
| Treatment history before study enrolment or at baseline | |
| MTX (n = 333) | |
| MTX stopped >1 week before TCZ start, n (%) | 114 (34.23) |
| No MTX, n (%) | 219 (65.77) |
| MTX dosage, mean (s.d.), mg/week (n=114) | 15.48 (4.411) |
| Reason for no MTX use, n (%) (n = 219) | |
| Non-adherence | 19 (8.68) |
| Intolerance or contraindications | 195 (89.04) |
| Other | 5 (2.28) |
| Conventional synthetic DMARDs (other than MTX) (n = 333) | |
| Conventional synthetic DMARD at enrolment, n (%) | 185 (55.56) |
| Conventional synthetic DMARD continued after TCZ initiation, n (%) | 119 (64.32) |
| Biologic treatment (n = 333) | |
| One biologic product (2L), n (%) | 138 (41.44) |
| Two or more biologic products (2L+), n (%) | 76 (22.82) |
| No biologic products (1L), n (%) | 119 (35.74) |
| CSs (n = 333) | |
| CS treatment at baseline, n (%) | 160 (48.05) |
| CS dosage at baseline, mean (s.d.), mg/month | 171.6 (107.4) |
| Parameter . | Safety population (n = 337, unless stated otherwise) . |
|---|---|
| Demographics | |
| Age, mean (s.d.), years | 57.58 (11.78) |
| Weight, mean (s.d.), kg | 72.8 (16.78) |
| Patient >65 years of age, n (%) | 94 (27.89) |
| Male/female, n (%) | 50/287 (14.84/85.16) |
| Disease characteristics | |
| DAS28 ESR at baseline, mean (s.d.) (n = 281) | 5.79 (0.97) |
| DAS28 CRP at baseline, mean (s.d.) (n = 52) | 5.8 (0.97) |
| CDAI at baseline, mean (s.d.) (n = 234) | 32.36 (12.54) |
| Treatment history before study enrolment or at baseline | |
| MTX (n = 333) | |
| MTX stopped >1 week before TCZ start, n (%) | 114 (34.23) |
| No MTX, n (%) | 219 (65.77) |
| MTX dosage, mean (s.d.), mg/week (n=114) | 15.48 (4.411) |
| Reason for no MTX use, n (%) (n = 219) | |
| Non-adherence | 19 (8.68) |
| Intolerance or contraindications | 195 (89.04) |
| Other | 5 (2.28) |
| Conventional synthetic DMARDs (other than MTX) (n = 333) | |
| Conventional synthetic DMARD at enrolment, n (%) | 185 (55.56) |
| Conventional synthetic DMARD continued after TCZ initiation, n (%) | 119 (64.32) |
| Biologic treatment (n = 333) | |
| One biologic product (2L), n (%) | 138 (41.44) |
| Two or more biologic products (2L+), n (%) | 76 (22.82) |
| No biologic products (1L), n (%) | 119 (35.74) |
| CSs (n = 333) | |
| CS treatment at baseline, n (%) | 160 (48.05) |
| CS dosage at baseline, mean (s.d.), mg/month | 171.6 (107.4) |
CDAI: clinical disease activity index; n: number of patients in group; TCZ: tocilizumab. Defined subgroups: 1L: first line = tocilizumab after failing DMARDs before enrolment; 2L: second line = tocilizumab after failing one biologic before enrolment; 2L+: third line = tocilizumab after failing two or more biologics before enrolment.
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