Table 2.
Safety monitoring during the first 24 months.
| Patient | Gender | Diagnoses | Event | Treatment modification (Time point) | Outcome after treatment modification |
|---|---|---|---|---|---|
| Death (n = 1) | |||||
| 1. | M | Neurosarcoidosis | Probable recurrent aspiration pneumonia | (6th month) | |
| Significant adverse events (n = 2) | |||||
| 2. | F | Sarcoidosis | Angioedema e·c·i· | Switched back to Remicade® (3rd month) | No more events with angioedema |
| 3. | F | SpA and vasculitis | New onset Interstitial lung disease | Changed over to rituximab (12th month) | Stable on rituximab |
| De novo ADA formation (n = 2) | |||||
| 4. | F | Sarcoidosis | Proximal muscle weakness in lower limbs +ADA | Discontinued with infliximab (6th month) | Muscle weakness caused by hypocalcaemia and improved after calcium supplementation |
| 5. | M | NeuroBehçet | ADA formation without clinical worsening | Changed over to adalimumab (9th month) | Stable on adalimumab |
| Disease relapses (n = 5) | |||||
| 6. | M | Neurosarcoidosis | Generalized seizures due to disease relapse | Switched back to Remicade® (6th month) | Stable on Remicade® |
| 7. | F | Granulomatous CVID | Generalized seizures due to disease relapse | Changed over to rituximab (6th month) | Stable on rituximab |
| 8. | M | Neurosarcoidosis | Reactivation underlying disease | Switched back to Remicade® (6th month) | Stable on Remicade® |
| 9. | F | Relapsing polychondritis | Reactivation underlying disease | Additional corticosteroid (5th month) | Disease in remission after short-term corticosteroid |
| 10. | F | Uveitis | Flare uveitis | Switched back to Remicade® (11th month) | Stable on Remicade® |
| Progression of pre-existing symptoms (n = 2) | |||||
| 11. | M | Sarcoidosis | Worsening of polyneuropathy | Switched back to Remicade® (4th month) | Improvements of symptoms on Remicade® |
| 12. | M | Neurosarcoidosis | Worsening of polyneuropathy | Switched back to Remicade® (5th month) | Improvements of symptoms on Remicade® |
| Other events (n = 2) | |||||
| 13. | F | Sarcoidosis | Worsening of headache | 1. Switched back to Remicade® (3rd month)Discontinued with infliximab (5th month) | Diagnosed with medication-induced headache, which improved after cessation of painkiller overuse |
| 14 | F | Uveitis | Severe nausea | Switched back to Remicade® (5th month) | Persistent nausea caused by diaphragmatic hernia |
| Mild adverse events (n = 8): Skin involvements (n = 4), Edema (n = 2), Arthralgia (n = 2) | |||||