Table 2.
Individual response data
| Case, AIHA type | Daratumumab treatment schedule | Time to partial Hb response in wk∗ (Hb, g/dL, Δ) | Time to complete Hb response in wk∗ (Hb, g/dL, Δ) | Best Hb response in wk from start daratumumab (Hb, g/dL, Δ) | Transfusion dependence (if transfusion dependent at baseline) | Acrocyanosis improved/resolved (for patients with acrocyanosis at baseline) | Duration of response after the start of daratumumab |
|---|---|---|---|---|---|---|---|
| 1 wAIHA | 8× weekly sc 1800 mg | - | 4 (12.5, +1.3) | 4 (12.5, +1.3) | - | - | 2 mo |
| 2 wAIHA | 8× weekly sc 1800 mg | 2 (11.9, +2.2) | 4 (13.4, +3.7) | 4 (13.4, +3.7) | - | - | 5 mo |
| 3 wAIHA | 8× weekly sc 1800 mg | 2 (11.0, +1.0) | 9 (12.4, +2.4) | 24 (13.4, +3.4) | - | - | Ongoing at 12 mo |
| 4 wAIHA | 4× weekly sc 1800 mg | - | 8 (12.7, +2.2) | 12 (13.5, +2) | - | - | Ongoing at 4 mo† |
| 5 wAIHA | 8× weekly sc 1800 mg, then 2× 2-weekly sc 1800mg | - | - | - | - | - | No response after 4 mo |
| 6 wAIHA | 8× weekly 16 mg/kg iv, 3 × 2-weekly 16 mg/kg IV | - | - | - | Ongoing | - | No response after 3, 5 mo |
| 7 wAIHA | 4× weekly 16mg/kg IV | 2 (12.1, +1.4) | 12 (14.6, +3.9) | - | - | 9 mo | |
| 8 wAIHA | 8× weekly 16 mg/kg IV | - | - | - | Ongoing | - | No response after 2, 5 mo |
| 9 wAIHA‡ | 4× weekly 16 mg/kg IV | - | - | - | - | - | No response after 2, 5 mo |
| 10 wAIHA | 4× weekly sc 1800 mg | 2 (10.1, + 4.0) | 4 (14.2, +8.1) | 24 (15.3, +9.2) | Transfusion independent after 14 d | - | Ongoing at 6 mo |
| 11 wAIHA | 4× weekly sc 1800 mg | - | - | - | Ongoing | - | No response after 2 mo |
| 12 wAIHA | 2× weekly 16 mg/kg IV 11× 2-weekly sc 1800 mg |
- | - | - | Ongoing | - | No response after 6 mo |
| 13 cAIHA | 8× weekly 16 mg/kg IV, 16x 2-weekly 16 mg/kg IV, 9× monthly 16 mg/kg IV | 12 (9.1, +2.1) | - | 40 (10.2, +3.2) | Transfusion independent after 6 mo | Improvement after 3 mo | 19 mo§ |
| 14 cAIHA | 8 × weekly sc 1800 mg | 2 (10.1, +1.3) | 16 (12.0, +3.2) | 24 (14.5, +5.7) | Transfusion independent after 3 mo | - | Ongoing at 8 mo |
| 15 cAIHA | First dose 16 mg/kg IV followed by 8× weekly sc 1800 mg, 8x 2-weekly sc 1800 mg, followed by maintenance 1800 mg sc monthly | - | ‖ | 8 (16.6, +4.1) | - | Improved after 2 wk Resolved after 3 mo |
Ongoing at 40 mo§ |
| 16 cAIHA | First dose 16mg/kg IV followed by 8× weekly sc 1800 mg, 8x 2-weekly sc 1800 mg, followed by maintenance 1800 mg sc monthly | - | 2 (12.7, +1.5) | 24 (14.8, +3.6) | - | Improved after 2 wk Resolved after 12 mo |
Ongoing at 12 mo§ |
| 17 cAIHA | First dose 16mg/kg IV followed by 8× weekly sc 1800 mg, 8x 2-weekly sc 1800 mg, followed by maintenance 1800 mg sc monthly | 4 (11.2, +2.7) | 12 (12.7, +4.2) | 12 (12.7, +4.2) | - | Improved after 6 mo | Ongoing at 11 mo§ |
| 18 cAIHA | 8× weekly sc 1800 mg | - | - | - | Ongoing | No response | No response after 2 mo |
| 19 cAIHA‡ | 8× weekly sc 1800 mg | - | - | - | Ongoing | No response | No response after 3 mo |
| Median (range) | 2 (2-12 wk) Δ + 2.2 g/dL (1.0-4.0) |
2 (2-16 wk) Δ + 2.3 g/dL (1.3-8.1) |
12 (2-40 wk) Δ + 3.7 g/dL (1.3-9.2) |
Δ, delta; NA, not applicable; sc, subcutaneously.
∗
Hb responses were defined as partial (PR, >2 g/dL Hb increase or >10g/dL) or complete (CR, >12g/dL).
†
Pat 4 has started belimumab for underlying SLE 4 months after the start of daratumumab, Hb response data not analyzed after 4 months. Patient is after 2 years still in CR of AIHA.
‡
Patient died due to uncontrolled hemolytic anemia
§
Daratumumab maintenance therapy until progression
‖
Treatment indication was severe acrocyanosis, therefore patient was excluded from assessment of Hb response.