Genovese_Kremer_Mar2017
Results – Safety Data Through Week 12 (Study 2) Adverse events, n (%) Placebo n=56 3 mg BID n=55 6 mg BID n=55 ABT-494 12 mg BID n=55 18 mg BID n=55 Any AE 25 (45) 26 (47) 31 (56) 37 (67) 39 (71) Any SAE 1 (2) 2 (4) 2 (4) 0 1 (2) Any AE leading to discontinuation 2 (4) 0 6 (11) 2 (4) 2 (4) AEs of special interest* Infection 12 (23) 11 (20) 12 (22) 22 (40) 21 (38) Serious infections 1 (2) 0 0 0 0 Cardiovascular event 0 0 1 (2)† 0 0 Herpes zoster 2 (4) 1 (2) 0 1 (2) 1 (2) Hepatic disorder 1 (2) 0 0 0 2 (4) Malignancy 0 0 1 (2)‡ 0 0 *Reported by the investigator; †Adjudicated as a transient ischemic attack by an externally led cardiovascular adjudication committee; ‡Basal cell and squamous carcinoma. Kremer JM, et al. Arthritis Rheum 2016;68:2867–77.
Conclusions • Selective JAK-1 inhibition with ABT-494 was effective in: – Patients with active RA and an inadequate response to MTX who were receiving background MTX – Refractory patients with an inadequate response to or intolerance of 1 anti- TNF agent • ABT-494 demonstrated a safety and tolerability profile consistent with other JAK inhibitors in RA – With high dosages (12/18 mg BID), the rate of infections was increased (40% in the 12 mg BID group 2 ) • Larger Phase 3 trials are underway to confirm the selectivity of ABT-494 against JAK- 1 and to determine whether this translates to an improved benefit–risk profile across a wide spectrum of patients with RA 1. Genovese MC, et al. Arthritis Rheum 2016;68:2857–66. 2. Kremer JM, et al. Arthritis Rheum 2016;68:2867–77.
- Page 1 and 2: Phase 2b Studies of ABT-494, a Sele
- Page 3 and 4: Background and Objectives • ABT-4
- Page 5 and 6: Methods - Study Design • These we
- Page 7 and 8: Results - Baseline Demographics and
- Page 9 and 10: Results - Primary Endpoint MTX inad
- Page 11 and 12: Response rate (%) Response rate (%)
- Page 13: Results - Safety Data Through Week
Results – Safety Data Through Week 12 (Study 2)<br />
Adverse events, n (%)<br />
Placebo<br />
n=56<br />
3 mg BID<br />
n=55<br />
6 mg BID<br />
n=55<br />
ABT-494<br />
12 mg BID<br />
n=55<br />
18 mg BID<br />
n=55<br />
Any AE 25 (45) 26 (47) 31 (56) 37 (67) 39 (71)<br />
Any SAE 1 (2) 2 (4) 2 (4) 0 1 (2)<br />
Any AE leading to discontinuation 2 (4) 0 6 (11) 2 (4) 2 (4)<br />
AEs of special interest*<br />
Infection 12 (23) 11 (20) 12 (22) 22 (40) 21 (38)<br />
Serious infections 1 (2) 0 0 0 0<br />
Cardiovascular event 0 0 1 (2)† 0 0<br />
Herpes zoster 2 (4) 1 (2) 0 1 (2) 1 (2)<br />
Hepatic disorder 1 (2) 0 0 0 2 (4)<br />
Malignancy 0 0 1 (2)‡ 0 0<br />
*Reported by the investigator; †Adjudicated as a transient ischemic attack by an externally led cardiovascular adjudication committee;<br />
‡Basal cell and squamous carcinoma.<br />
<strong>Kremer</strong> JM, et al. Arthritis Rheum 2016;68:2867–77.
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