Patients who experienced adverse drug events – table reports data on 44 patients naïve to originators: one JIA child had no follow-up data at 3–6-12 months, thus adverse event information was not available
| . | Follow-up . | ||
|---|---|---|---|
| 3 months | 6 months | 12 months | |
| Adalimumab | |||
| Originator | 10/27 | 9/25 | 11/25 |
| ADEs description | 1 nausea | 1 abdominal pain | 1 appendicitis |
| 7 infections | 8 infections | 1 gastroenteritis | |
| 1 loss of consciousness | 1 abdominal pain | ||
| 1 urticaria | 2 burning/pain at the injection site | ||
| 11 infections | |||
| Biosimilar | 7/33 | 14/29 | 9/23 |
| ADEs description | 1 nausea | 1 gastroenteritis | 7 infections |
| 1 burning/pain at the injection site | 2 burning/pain at the injection site | 1 gastroenteritis | |
| 5 infections | 9 infections | 1 headache | |
| 1 headache | 1 impetigo | ||
| χ 1.83 P =0.170 | χ 0.82 P =0.360 | χ 0.11 P =0.730 | |
| n of serious ADEs | — | 1/29 | — |
| Etanercept | |||
| Originator | 4/17 | 6/17 | 6/17 |
| ADEs description | 4 infections | 1 burning/pain at the injection site | 1 anaemia |
| 1 headache | 4 infections | 1 burning/pain at the injection site | |
| 1 psoriasis | 3 infections | ||
| 1 headache | |||
| 1 erythema | |||
| Biosimilar | 1/20 | 4/14 | 3/13 |
| ADEs description | 1 burning at the injection site | 1 burning/pain at the injection site | 2 burning/pain at the injection site |
| 3 infections | 2 infections | ||
| 1 cutaneous rash | |||
| 1 chondromatosis of the knee | |||
| χ 2.69 P =0.100 | χ 0.15 P =0.690 | χ 0.52 P =0.460 | |
| n of serious ADEs | — | — | — |
| . | Follow-up . | ||
|---|---|---|---|
| 3 months | 6 months | 12 months | |
| Adalimumab | |||
| Originator | 10/27 | 9/25 | 11/25 |
| ADEs description | 1 nausea | 1 abdominal pain | 1 appendicitis |
| 7 infections | 8 infections | 1 gastroenteritis | |
| 1 loss of consciousness | 1 abdominal pain | ||
| 1 urticaria | 2 burning/pain at the injection site | ||
| 11 infections | |||
| Biosimilar | 7/33 | 14/29 | 9/23 |
| ADEs description | 1 nausea | 1 gastroenteritis | 7 infections |
| 1 burning/pain at the injection site | 2 burning/pain at the injection site | 1 gastroenteritis | |
| 5 infections | 9 infections | 1 headache | |
| 1 headache | 1 impetigo | ||
| χ 1.83 P =0.170 | χ 0.82 P =0.360 | χ 0.11 P =0.730 | |
| n of serious ADEs | — | 1/29 | — |
| Etanercept | |||
| Originator | 4/17 | 6/17 | 6/17 |
| ADEs description | 4 infections | 1 burning/pain at the injection site | 1 anaemia |
| 1 headache | 4 infections | 1 burning/pain at the injection site | |
| 1 psoriasis | 3 infections | ||
| 1 headache | |||
| 1 erythema | |||
| Biosimilar | 1/20 | 4/14 | 3/13 |
| ADEs description | 1 burning at the injection site | 1 burning/pain at the injection site | 2 burning/pain at the injection site |
| 3 infections | 2 infections | ||
| 1 cutaneous rash | |||
| 1 chondromatosis of the knee | |||
| χ 2.69 P =0.100 | χ 0.15 P =0.690 | χ 0.52 P =0.460 | |
| n of serious ADEs | — | — | — |
ADE: adverse drug event.
Patients who experienced adverse drug events – table reports data on 44 patients naïve to originators: one JIA child had no follow-up data at 3–6-12 months, thus adverse event information was not available
| . | Follow-up . | ||
|---|---|---|---|
| 3 months | 6 months | 12 months | |
| Adalimumab | |||
| Originator | 10/27 | 9/25 | 11/25 |
| ADEs description | 1 nausea | 1 abdominal pain | 1 appendicitis |
| 7 infections | 8 infections | 1 gastroenteritis | |
| 1 loss of consciousness | 1 abdominal pain | ||
| 1 urticaria | 2 burning/pain at the injection site | ||
| 11 infections | |||
| Biosimilar | 7/33 | 14/29 | 9/23 |
| ADEs description | 1 nausea | 1 gastroenteritis | 7 infections |
| 1 burning/pain at the injection site | 2 burning/pain at the injection site | 1 gastroenteritis | |
| 5 infections | 9 infections | 1 headache | |
| 1 headache | 1 impetigo | ||
| χ 1.83 P =0.170 | χ 0.82 P =0.360 | χ 0.11 P =0.730 | |
| n of serious ADEs | — | 1/29 | — |
| Etanercept | |||
| Originator | 4/17 | 6/17 | 6/17 |
| ADEs description | 4 infections | 1 burning/pain at the injection site | 1 anaemia |
| 1 headache | 4 infections | 1 burning/pain at the injection site | |
| 1 psoriasis | 3 infections | ||
| 1 headache | |||
| 1 erythema | |||
| Biosimilar | 1/20 | 4/14 | 3/13 |
| ADEs description | 1 burning at the injection site | 1 burning/pain at the injection site | 2 burning/pain at the injection site |
| 3 infections | 2 infections | ||
| 1 cutaneous rash | |||
| 1 chondromatosis of the knee | |||
| χ 2.69 P =0.100 | χ 0.15 P =0.690 | χ 0.52 P =0.460 | |
| n of serious ADEs | — | — | — |
| . | Follow-up . | ||
|---|---|---|---|
| 3 months | 6 months | 12 months | |
| Adalimumab | |||
| Originator | 10/27 | 9/25 | 11/25 |
| ADEs description | 1 nausea | 1 abdominal pain | 1 appendicitis |
| 7 infections | 8 infections | 1 gastroenteritis | |
| 1 loss of consciousness | 1 abdominal pain | ||
| 1 urticaria | 2 burning/pain at the injection site | ||
| 11 infections | |||
| Biosimilar | 7/33 | 14/29 | 9/23 |
| ADEs description | 1 nausea | 1 gastroenteritis | 7 infections |
| 1 burning/pain at the injection site | 2 burning/pain at the injection site | 1 gastroenteritis | |
| 5 infections | 9 infections | 1 headache | |
| 1 headache | 1 impetigo | ||
| χ 1.83 P =0.170 | χ 0.82 P =0.360 | χ 0.11 P =0.730 | |
| n of serious ADEs | — | 1/29 | — |
| Etanercept | |||
| Originator | 4/17 | 6/17 | 6/17 |
| ADEs description | 4 infections | 1 burning/pain at the injection site | 1 anaemia |
| 1 headache | 4 infections | 1 burning/pain at the injection site | |
| 1 psoriasis | 3 infections | ||
| 1 headache | |||
| 1 erythema | |||
| Biosimilar | 1/20 | 4/14 | 3/13 |
| ADEs description | 1 burning at the injection site | 1 burning/pain at the injection site | 2 burning/pain at the injection site |
| 3 infections | 2 infections | ||
| 1 cutaneous rash | |||
| 1 chondromatosis of the knee | |||
| χ 2.69 P =0.100 | χ 0.15 P =0.690 | χ 0.52 P =0.460 | |
| n of serious ADEs | — | — | — |
ADE: adverse drug event.
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