Table 3.
Disease indication | Studies | N | Total number of studies with | ||
---|---|---|---|---|---|
Efficacy data | Safety data | Immunogenicity data | |||
Larger biologics | |||||
Rheumatoid arthritis | 8 | 3,090 | 5 | 6 | 6 |
Inflammatory bowel disease | 22 | 2,105 | 18 | 20 | 8 |
Plaque psoriasis | 5 | 983 | 5 | 2 | 2 |
Crohn’s disease | 5 | 372 | 4 | 4 | 2 |
Spondyloarthritis | 1 | 41 | 1 | 1 | 1 |
Healthy volunteers | 2 | 192 | 0 | 1 | 1 |
Rheumatic disease | 2 | 62 | 0 | 0 | 1 |
Ankylosing spondylitis | 1 | 174 | 1 | 1 | 1 |
Ulcerative colitis | 1 | 40 | 1 | 0 | 0 |
Combined indications* | 7 | 1,384 | 1 | 4 | 2 |
Total for larger biologics | 54 | 8,443 | 36 | 39 | 24 |
Smaller biologics | |||||
Chronic kidney disease | 7 | 2,076 | 6 | 12 | 6 |
Hemodialysis | 4 | 1,959 | 4 | 0 | 1 |
End-stage renal disease | 2 | 479 | 2 | 3 | 1 |
Growth hormone deficiency | 9 | 470 | 4 | 4 | 3 |
Cancer | 2 | 320 | 1 | 1 | 1 |
Healthy volunteers | 10 | 437 | 1 | 3 | 1 |
Neutropenia | 2 | 41 | 1 | 2 | 0 |
Total for smaller biologics | 36 | 5,782 | 19 | 25 | 13 |
Total | 90 | 14,225 | 55 | 64 | 37 |
*Seven studies involving larger biologics included patients treated for different indications