Proposals for revised IWG-ELN response criteria for anemia in MF
| . | 2013 IWG-ELN criteria . | 2024 proposed IWG-ELN criteria . |
|---|---|---|
| Definitions | ||
| Hgb cutoffs for clinical trial inclusion or response adjudication | <10 g/dL | Men <11 g/dL∗,† Women <10 g/dL∗ |
| TDA | ≥6 units in the 12 wk before enrollment‡ (only transfusions for Hb <8.5 g/dL are counted) | ≥3 units in the 12 wk before enrollment‡,§ (high transfusion burden defined as ≥6 units in the 12 wk before enrollment) |
| Baseline Hgb for TDA | Not clearly defined | Average of pretransfusion Hb levels in the 12 wk before enrollment/first dose§ |
| Non-TDA | Not meeting criteria for TDA | Not meeting criteria for TDA |
| Baseline Hb for non-TDA | Hb level at time of screening | Average of the lowest 3 Hb levels in the 12 wk before enrollment/first dose, including one obtained in the 28 d before enrollment/first dose§,|| |
| Anemia response criteria | ||
| Major response for TDA | No transfusions during any rolling 12-wk period + a documented Hb level of ≥8.5 g/dL | No transfusions × 12 wk¶ and rolling 12-wk average Hb increase of ≥1.5 g/dL from pretreatment baseline |
| Major response for non-TDA | Rolling 12-wk average Hb increase of ≥2.0 g/dL from pretreatment baseline# | Rolling 12-wk average Hb increase of ≥1.5 g/dL from pretreatment baseline (also requires no transfusions) |
| Minor response for TDA | Not included | A ≥50% reduction in transfusions∗∗ (and not meeting criteria for major response) |
| Minor response for non-TDA | Not included | Rolling 12-wk average Hb increase of ≥1.0 g/dL from pretreatment baseline∗∗ (also requires no transfusions and not meeting criteria for major response) |
| Loss of response | Loss of anemia response persisting for ≥1 mo | No longer meeting criteria for even minor response†† |
| Duration of anemia response | Not defined | Interval between first time point of response to first time point of loss of response |
| Progressive anemia | Not defined | TDA: ≥50% increase in transfusion requirement∗∗ Non-TDA: Hb decrease of >1.5 g/dL from baseline or meeting criteria for TDA∗∗ |
| Stable anemia | Not defined | Not meeting criteria for response or progression |
| . | 2013 IWG-ELN criteria . | 2024 proposed IWG-ELN criteria . |
|---|---|---|
| Definitions | ||
| Hgb cutoffs for clinical trial inclusion or response adjudication | <10 g/dL | Men <11 g/dL∗,† Women <10 g/dL∗ |
| TDA | ≥6 units in the 12 wk before enrollment‡ (only transfusions for Hb <8.5 g/dL are counted) | ≥3 units in the 12 wk before enrollment‡,§ (high transfusion burden defined as ≥6 units in the 12 wk before enrollment) |
| Baseline Hgb for TDA | Not clearly defined | Average of pretransfusion Hb levels in the 12 wk before enrollment/first dose§ |
| Non-TDA | Not meeting criteria for TDA | Not meeting criteria for TDA |
| Baseline Hb for non-TDA | Hb level at time of screening | Average of the lowest 3 Hb levels in the 12 wk before enrollment/first dose, including one obtained in the 28 d before enrollment/first dose§,|| |
| Anemia response criteria | ||
| Major response for TDA | No transfusions during any rolling 12-wk period + a documented Hb level of ≥8.5 g/dL | No transfusions × 12 wk¶ and rolling 12-wk average Hb increase of ≥1.5 g/dL from pretreatment baseline |
| Major response for non-TDA | Rolling 12-wk average Hb increase of ≥2.0 g/dL from pretreatment baseline# | Rolling 12-wk average Hb increase of ≥1.5 g/dL from pretreatment baseline (also requires no transfusions) |
| Minor response for TDA | Not included | A ≥50% reduction in transfusions∗∗ (and not meeting criteria for major response) |
| Minor response for non-TDA | Not included | Rolling 12-wk average Hb increase of ≥1.0 g/dL from pretreatment baseline∗∗ (also requires no transfusions and not meeting criteria for major response) |
| Loss of response | Loss of anemia response persisting for ≥1 mo | No longer meeting criteria for even minor response†† |
| Duration of anemia response | Not defined | Interval between first time point of response to first time point of loss of response |
| Progressive anemia | Not defined | TDA: ≥50% increase in transfusion requirement∗∗ Non-TDA: Hb decrease of >1.5 g/dL from baseline or meeting criteria for TDA∗∗ |
| Stable anemia | Not defined | Not meeting criteria for response or progression |
In the absence of nutritional anemia including iron or vitamin B12 deficiency. In patients receiving replacement therapy, an observation period of 3 months is required before establishing a baseline Hb level.
For clinical trial purposes, it is equally reasonable to use a Hb threshold of <10 g/dL, in both men and women, as an inclusion criterion.
Most recent transfusion episode must have occurred in the 28 days before enrollment.
Transfusions or Hb measurements considered are only those obtained after completion of drug washout period.
If transfused in the 28 days before enrollment, baseline should include pretransfusion but not post-transfusion Hb levels.
Transfusion policy before enrollment should be the same as after enrollment.
Applicable only for patients with baseline Hb of <10 g/dL.
12-week period of assessment required before and after enrollment.
Short periods of decline in Hb level, which are attributed to a clear alternative cause, such as bleeding or surgery, should not qualify as “loss of response.”