Table 1.
Characteristics of FAERS patients who developed natalizumab‐associated melanoma (n = 137 cases)
| Total | US | Non‐US | |
|---|---|---|---|
| FAERS | N = 137 | N = 95 (69%) | N = 42 (31%) |
| Age (median [range]) | 45 [21, 74] | 47 [21, 74] | 39 [21, 63] |
| Number of updates reported to the FDA (median) | 2 | 2 | 1 |
| Number of months of information from the time of melanoma diagnosis (median) | 4 | 5 | 4 |
| Female (%) | 106 (77) | 73 (77) | 33 (79) |
| Disease natalizumab prescribed for N (%) | |||
| Multiple Sclerosis | 135 (98) | 93 (98) | 42 (100) |
| Crohn's | 1 (1) | 1 (1) | 0 |
| Not Known | 1 (1) | 1 (1) | 0 |
| Melanoma Site N (%) | |||
| Cutaneous | 104 (76) | 73 (77) | 31 (74) |
| Mucosal | 2 (1) | 2 (2) | 0 |
| Ocular | 5 (4) | 3 (3) | 2 (5) |
| Not known | 26 (19) | 17 (18) | 9 (21) |
| Site sun exposed N (%) | |||
| Yes | 88 (64) | 62 (65) | 26 (62) |
| No | 23 (17) | 17 (18) | 6 (14) |
| Not Known | 26 (19) | 16 (17) | 10 (24) |
| Time on natalizumab until melanoma diagnosis N (%) | |||
| 0–24 months | 47 (34) | 36 (38) | 11 (26) |
| 25–48 months | 26 (19) | 13 (14) | 13 (31) |
| 49–72 months | 10 (7) | 4 (4) | 6 (14) |
| 73–96 months | 1 (1) | 1 (1) | 0 |
| Not specified | 53 (39) | 41 (43) | 12 (29) |
| Alive at follow‐up N (%) | 128 (93) | 88 (93) | 40 (95) |
| Concomitant drug use N (%) | 51 (37) | 30 (32) | 21 (50) |
| Nevi history N (%) | |||
| Yes | 30 (22) | 18 (19) | 12 (29) |
| No | 30 (22) | 20 (21) | 10 (24) |
| Unknown | 77 (56) | 57 (60) | 20 (48) |
| Melanoma treatment N (%) | |||
| Chemotherapy | 2 (1) | 2 (2) | 0 |
| Chemotherapy and radiation | 1 (1) | 1 (1) | 0 |
| Surgery | 92 (67) | 61 (64) | 31 (74) |
| Radiation | 1 (1) | 0 | 1 (2) |
| Surgery combination | 9 (7) | 9 (9) | 0 |
| Other | 3 (2) | 2 (2) | 1 (2) |
| No | 1 (1) | 0 | 1 (2) |
| Not applicable | 17 (12) | 12 (13) | 5 (12) |
| Unknown | 11 (8) | 8 (8) | 3 (7) |
| TOUCH N (%) | |||
| Data obtained from TOUCHa | N/A | 14 (15) | 0 |
| FAERS report supplemented by TOUCH datab | N/A | 69 (73) | 0 |
| FAERS data without any TOUCH datac | N/A | 12 (13) | 42 (100) |
| Change in Nevi N (%) | |||
| Yes | 22 (16) | 14 (15) | 8 (19) |
| No | 115 (84) | 81 (85) | 34 (81) |
| Reporter N (%) | |||
| Neurologist | 37 (27) | 28 (29) | 12 (29) |
| Unknown | 25 (18) | 9 (9) | 14 (33) |
| Patient | 22 (16) | 19 (20) | 0 |
| Nurse | 16 (12) | 16 (17) | 1 (2) |
| Physician | 9 (7) | 3 (3) | 6 (14) |
| Family | 4 (4) | 5 (5) | 0 |
| Registered nurse | 5(4) | 5 (5) | 0 |
| Investigator | 5 (4) | 1 (1) | 5 (12) |
| Physician assistant | 2 (1) | 2 (2) | 0 |
| ANSM | 2 (1) | 0 | 2 (5) |
| Health care professional | 2 (1) | 2 (2) | 0 |
| Consumer | 1 (1) | 1 (1) | 0 |
| Doctor | 1 (1) | 1 (1) | 0 |
| Manufacturer report | 1 (1) | 1 (1) | 0 |
| Other authority | 1 (1) | 0 | 1 (2) |
| Assistant | 2 (1) | 1 (1) | 0 |
| Nurse practitioner | 1 (1) | 1 (1) | 0 |
Case information was obtained from the FDA's Adverse Event Reporting System (FAERS). (Between April 1, 2014 and June 30, 2016, 45 additional natalizumab‐associated melanoma cases were reported to FAERS‐ 12 from ex‐United States countries and 33 from the United States. These cases are not included in Table 1).
a
Cases reported to the FDA directly from the TOUCH Safety Surveillance Program.
b
Cases reported to the FDA independent of TOUCH but with supplemental information obtained from the TOUCH Safety Surveillance Program.
c
Cases reported to the FDA with no information obtained from the TOUCH Safety Surveillance Protocol.