Table 5.
Challenge | 1st gliptin dose to MMP onset (wk) | Challengea | Dechallenge | Rechallenge R0/R+/R– | Begaud’s accountability scoresb | Naranjo’s scorec | ||||
---|---|---|---|---|---|---|---|---|---|---|
gliptin patient | Yes/no | Outcome | C1–C3 | S1–S3 | I1–16 | 0–13 | ADR | |||
Dechallenge | ||||||||||
Saxagliptin | ||||||||||
1 | 4 | Suggestive | Yes | Suggestive | R0 | C3 | S1 | I4 | 3 | Possible |
Vildagliptin | ||||||||||
2 | 4 | Suggestive | Yes | Suggestive | R0 | C3 | S1 | I4 | 3 | Possible |
3 | 4 | Suggestive | Yes | Inconclusive | R0 | C2 | S1 | I2 | 2 | Possible |
4 | 12 | Suggestive | Yes | Inconclusive | R0 | C2 | S1 | I2 | 2 | Possible |
5 | 36 | Compatible | Yes | Suggestive | R0 | C2 | S1 | I2 | 3 | Possible |
6 | 36 | Compatible | Yes | Not suggestive | R0 | C1 | S1 | I1 | 2 | Possible |
7 | 144 | Compatible | Yes | Inconclusive | R0 | C1 | S2 | I2 | 2 | Possible |
Sitagliptin | ||||||||||
8 | 104 | Compatible | Yes | Suggestive | R+ | C3 | S1 | I4 | 6 | Probable |
9 | 136 | Compatible | Yes | Suggestive | R0 | C2 | S1 | I2 | 3 | Possible |
10 | 144 | Compatible | Yes | Inconclusive | R0 | C1 | S1 | I1 | 2 | Possible |
11 | 232 | Compatible | Yes | Suggestive | R0 | C2 | S2 | I3 | 3 | Possible |
No dechallenge | ||||||||||
Vildagliptin | ||||||||||
12 | 72 | Compatible | No | Suggestive | R0 | C2 | S1 | I2 | 2 | Possible |
13 | 148 | Compatible | No | Inconclusive | R0 | C1 | S1 | I1 | 2 | Possible |
14 | 236 | Compatible | No | Inconclusive | R0 | C1 | S2 | I2 | 2 | Possible |
15 | 244 | Compatible | No | Not suggestive | R0 | C1 | S2 | I2 | 2 | Possible |
16 | 588 | Compatible | No | Not suggestive | R0 | C1 | S1 | I1 | 2 | Possible |
Sitagliptin | ||||||||||
17 | 144 | Compatible | No | Inconclusive | R0 | C2 | S2 | I3 | 2 | Possible |
MMP, mucous membrane pemphigoid; wk, week; R0, no rechallenge; R+, positive rechallenge; R–, negative rechallenge; ADR, adverse drug reaction.
aSuggestive, time to onset ≤12 weeks; compatible, time to onset >12 weeks.
bChronological score: C1, doubtful; C2, plausible; C3, likely. Symptomatological scoring: S1, doubtful; S2, plausible; S3, likely. Intrinsic accountability scoring [combining chronological (C) and symptomatological (S) scores]: I1 (C1S1), I2 (C1S2 or C2S1), I3 (C2S2), I4 (C1S3 or C3S1), I5 (C2S3 or C3S2), and I6 (C3S3) (32).
cNarango’s score: >9, definite ADR; 5–8, probable ADR; 1–4, possible ADR; 0, doubtful ADR (34).