April 2020 HSC Section 4 - Plastic and Reconstructive Problems

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G LOGAU E T A L

TABLE 3. Summary of AEs

Mild SMF,* n = 47

Extreme SMF,* n = 46

Placebo, n = 16

ATX-101, n = 31

Placebo, n = 16

ATX-101, n = 30

Duration, Days, Median (Max)

Incidence, n (%)

AEs

Mild

11 (68.8)

— 10 (32.3)

— 11 (68.8)

— 13 (43.3)

—

Moderate

4 (25.0)

— 20 (64.5)

— 2 (12.5)

— 15 (50.0)

—

Severe

—

— 1 (3.3)

—

Injection site AEs reported in $ 10% of

subjects in any treatment group Pain

8 (50.0)

5.2 (13)

23 (74.2)

10.8 (225)

5 (31.3)

4.5 (6)

16 (53.3)

7.0 (224)

Bruising

8 (50.0)

6.8 (12)

15 (48.4)

8.3 (18)

9 (56.3)

7.3 (10)

18 (60.0)

12.0 (39)

Edema

4 (25.0)

3.8 (5)

13 (41.9)

8.5 (22)

3 (18.8)

4.0 (4)

14 (46.7)

10.3 (39)

Anesthesia

1 (6.3)

14.0 (14)

15 (48.4)

62.0 (225)

1 (6.3)

1.0 (1)

16 (53.3)

22.0 (197)

(numbness)

Swelling

2 (12.5)

3.1 (4)

13 (41.9)

20.0 (85)

2 (12.5)

5.0 (9)

14 (46.7)

8.8 (32)

Pruritus

1 (6.3)

3.0 (3)

4 (12.9)

6.0 (9)

2 (12.5)

3.0 (3)

3 (10.0)

13.0 (29)

Induration

— 4 (12.9)

24.5 (78)

1 (6.3)

24.0 (24)

3 (10.0)

16.0 (34)

Nodule

— 4 (12.9)

49.0 (161)

— 4 (13.3)

100.5 (170)

Erythema

— 2 (6.5)

4.0 (4)

1 (6.3)

3.0 (3)

3 (10.0)

4.0 (5)

Paresthesia

2 (12.5)

4.0 (7)

2 (6.5)

3.0 (5)

—

Noninjection site AEs reported in $ 10% of

subjects in any treatment group Skin tightness

— 3 (9.7)

2.7 (6)

— 4 (13.3)

16.0 (39)

Headache

1 (6.3)

2 (6.5)

1 (6.3)

3 (10.0)

*Mild or extreme SMF defined as a grade of 1 or 4, respectively, on the Clinician-Reported SMF Rating Scale at baseline. AE, adverse event; NA, not available; SMF, submental fat.

indicated population (i.e., subjects with moderate or severe SMF). 7 – 10 Here, in subjects with either mild or extreme SMF, signi fi cant differences betweenATX-101 and placebo were observed 12 weeks after last treat- ment in CR-1, PR-1, composite CR-1/PR-1, SSRS, and PR-SMFIS TSS scores. The composite CR-1/PR-1 measure was more stringent than either individual scale and also reduced the placebo effect, which is quite common in aesthetic trials. 17 Subjects treated with ATX-101 versus placebo also showed signi fi cantly better scores in SGQ, subject line drawing assessment, self-ratings of attractiveness, and FACE-Q, regardless of baseline SMF severity, indicating high levels of sat- isfaction with treatment. Despite the signi fi cant reduc- tions in SMF, skin laxitywas unchanged or improved in all ATX-101 – treated subjects.

There were noteworthy differences in outcomes between subjects with mild and extreme SMF. Generally, subjects with extreme SMF exhibited larger differences between ATX-101 and placebo versus subjects with mild SMF. In addition, subjects with mild SMF were more likely to receive <6 treatments compared with those with extreme SMF. This is not unexpected given that, by de fi nition, those with mild SMF had less volume to treat, and many received <6 treatments because of insuf fi cient SMF for injection or subject satisfaction with SMF reduction. The smaller SMF surface area of subjects with mild versus extreme SMF limits the number of injections such that subjects with mild SMF received a lower total volume of ATX-101 in slightly fewer treatments.

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