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) |
| 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.