Demographics of the study population
| Characteristic . | Total cohort . | SM cohort . | |
|---|---|---|---|
| 1 July 2023 (n = 249) . | 1 July 2023 (n = 94) . | 1 July 2021 (n = 47) . | |
| Age (y), median (IQR) | 46 (37-61) | 47 (37-60) | 47 (38-62) |
| Sex | |||
| Female | 42.2% (105/249) | 37.2% (35/94) | 48.9% (23/47) |
| Male | 57.8% (144/249) | 62.8% (59/94) | 51.1% (24/47) |
| BST levels (ng/mL) | |||
| BST <11.5 (n) | 11.6% (29/249) | 14.9% (14/94) | 4.3% (2/47) |
| BST 11.5 to 14.9 (n) | 23.7% (59/249) | 16.0% (15/94) | 2.1% (1/47) |
| BST 15.0 to 19.9 (n) | 27.7% (69/249) | 17.0% (16/94) | 14.9% (7/47) |
| BST ≥20 (n) | 36.9% (92/249) | 52.1% (49/94) | 78.7% (37/47) |
| HαT tested–positive/total tested (%) | 43.8% (96/219) | 6.6% (5/76)† | 0.0% (0/1)† |
| BST (ng/mL) in HαT+ (mean [95% CI]) | 18.6 (15.3-21.9) | 71.1 (13.6-128.6) | NA |
| BST (ng/mL) in HαT- (mean [95% CI]) | 24.3 (19.5-29.1) | 29.6 (21.9-37.3) | NA |
| History of anaphylaxis (n) | 37.3% (93/249) | 42.6% (40/94) | 29.8% (14/47) |
| REMA score | |||
| REMA ≥ 2 | 60.2% (56/93) | 82.5% (33/40) | 100% (14/14) |
| REMA < 2 | 39.8% (37/93) | 17.5% (7/40) | 0% (0/14) |
| History of monomorphic MPCM (n) | 30.1% (75/249) | 63.8% (60/94) | 85.1% (40/47) |
| KIT p.D816V PB or BM- positive/total (%) | 31.7% (79/249) | 84.0% (79/94)∗ | 51.1% (24/47) |
| Characteristic . | Total cohort . | SM cohort . | |
|---|---|---|---|
| 1 July 2023 (n = 249) . | 1 July 2023 (n = 94) . | 1 July 2021 (n = 47) . | |
| Age (y), median (IQR) | 46 (37-61) | 47 (37-60) | 47 (38-62) |
| Sex | |||
| Female | 42.2% (105/249) | 37.2% (35/94) | 48.9% (23/47) |
| Male | 57.8% (144/249) | 62.8% (59/94) | 51.1% (24/47) |
| BST levels (ng/mL) | |||
| BST <11.5 (n) | 11.6% (29/249) | 14.9% (14/94) | 4.3% (2/47) |
| BST 11.5 to 14.9 (n) | 23.7% (59/249) | 16.0% (15/94) | 2.1% (1/47) |
| BST 15.0 to 19.9 (n) | 27.7% (69/249) | 17.0% (16/94) | 14.9% (7/47) |
| BST ≥20 (n) | 36.9% (92/249) | 52.1% (49/94) | 78.7% (37/47) |
| HαT tested–positive/total tested (%) | 43.8% (96/219) | 6.6% (5/76)† | 0.0% (0/1)† |
| BST (ng/mL) in HαT+ (mean [95% CI]) | 18.6 (15.3-21.9) | 71.1 (13.6-128.6) | NA |
| BST (ng/mL) in HαT- (mean [95% CI]) | 24.3 (19.5-29.1) | 29.6 (21.9-37.3) | NA |
| History of anaphylaxis (n) | 37.3% (93/249) | 42.6% (40/94) | 29.8% (14/47) |
| REMA score | |||
| REMA ≥ 2 | 60.2% (56/93) | 82.5% (33/40) | 100% (14/14) |
| REMA < 2 | 39.8% (37/93) | 17.5% (7/40) | 0% (0/14) |
| History of monomorphic MPCM (n) | 30.1% (75/249) | 63.8% (60/94) | 85.1% (40/47) |
| KIT p.D816V PB or BM- positive/total (%) | 31.7% (79/249) | 84.0% (79/94)∗ | 51.1% (24/47) |
Twenty-nine of the 47 patients diagnosed with SM by 1 July 2021 were tested for HαT between 1 July 2021 and 1 July 2023 and 4 were positive for HαT (4/30). Forty-six of the 47 patients diagnosed with SM between 1 July 2021 and 1 July 2023 were tested for HαT and 1 was positive for HαT.
Nine of 94 patients with SM did not have high-sensitivity PCR testing of KIT p.D816V in PB and/or BM.
Only 1 patient diagnosed with SM by 1 July 2021 was also tested for HαT by 1 July 2021.