Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: GO-AFTER was the first multicenter, randomized, placebo (PBO)-controlled trial of the safety/efficacy of an anti-TNFα agent, GLM, in pts with active RA despite prior anti-TNFα therapy.
Objective: Final safety and efficacy results through 5yrs are reported.
Methods: Pts were randomized (1:1:1) to PBO, GLM 50mg, or GLM 100mg q4w. At wk16, pts with inadequate treatment response entered double-blind early escape: PBO to GLM 50mg or GLM 50mg to 100mg. At wk24 (start of long-term extension), pts still receiving PBO switched to GLM 50mg, all other pts continued current treatment. After the last pt completed the wk24 visit, unblinding occurred, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted at investigator’s discretion. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, CDAI) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively. Efficacy data from 1 site (16 pts) were excluded (protocol violations).
Results: 461 pts were randomized, and 459 received study agent; 183 pts continued treatment through wk252, and 276 pts withdrew (86 for AE, 107 for lack of efficacy, 9 lost to follow-up, 69 for other reasons, 5 deaths). 178 completed the safety follow-up through wk268. Efficacy results are shown in the table. Of pts with available data at wk256, 60.3% had an ACR20, 42.3% had an ACR50, 21.7% had an ACR70, 84.3% had DAS28-CRP EULAR response, 29.0% had DAS28-CRP <2.6, and 16.0% had CDAI≤2.8. The most common AEs were upper respiratory tract infection(27.1%), sinusitis(17.1%), and nasopharyngitis(16.9%). Through wk268, 151/431 pts had an SAE, with similar rates among dose groups (50mg only, 50 and 100mg, 100mg only) Rates of serious infections, malignancies, and death were 13.9%, 4.6%, and 2.1%, respectively. 12.3% of pts had ≥1 injection-site reaction. Of 388 pts with available samples, 31 (8.0%) tested positive for antibodies to GLM.
Conclusion: GLM efficacy was maintained through 5yrs among pts with refractory RA who continued treatment. The long-term safety of GLM is consistent with other anti-TNFα agents.
Table. Efficacy results at wk256.
|
|
PBO/GLMa |
GLM 50mgb |
GLM 100mgc |
Total |
|
ACR20 |
37/57 (64.9%) |
39/65 (60.0%) |
38/67 (56.7%) |
114/189 (60.3%) |
|
ACR50 |
24/57 (42.1%) |
26/65 (40.0%) |
30/67 (44.8%) |
80/189 (42.3%) |
|
ACR70 |
10/57 (17.5%) |
16/65 (24.6%) |
15/67 (22.4%) |
41/189 (21.7%) |
|
DAS28-CRP EULAR Response |
50/55 (90.9%) |
53/65 (81.5%) |
53/65 (81.5%) |
156/185 (84.3%) |
|
DAS28-ESR EULAR Response |
48/56 (85.7%) |
47/65 (72.3%) |
49/64 (76.6%) |
144/185 (77.8%) |
|
DAS28-CRP <2.6 |
18/55 (32.7%) |
16/65 (24.6%) |
20/66 (30.3%) |
54/186 (29.0%) |
|
DAS28-ESR <2.6 |
13/56 (23.2%) |
14/65 (21.5%) |
13/66 (19.7%) |
40/187 (21.4%) |
|
CDAI ≤2.8 |
7/56(12.5%) |
10/65(15.4%) |
13/67(19.4%) |
30/188(16.0%) |
a Pts randomized to PBO who switched to GLM 50mg at wk16 or 24; after wk24 pts could receive GLM50 or 100mg.
b After wk 24 pts could receive GLM50 or 100mg.
c After wk 24 pts could receive GLM100 or 50mg.
Disclosure:
J. S. Smolen,
Janssen Research & Development, LLC.,
5;
J. Kay,
Abbott Laboratories,
2,
Ardea Biosciences,
2,
Eli Lilly and Company,
2,
Fidia Farmacutici, SpA,
2,
Pfizer Inc,
2,
Roche Laboratories,
2,
sanofi-aventis,
2,
Amgen Inc.,
5,
Baxter Healthcare Corporation,
5,
Bristol-Myers Squibb Company,
5,
Celgene Corp.,
5,
fourteen22 Inc.,
5,
Genentech Inc.,
5,
Hospira, Inc.,
5,
Horizon Pharma, Inc.,
5,
Janssen Biotech, Inc.,
5,
medac pharma Inc.,
5,
PanGenetics, B.V.,
5,
Pfizer Inc.,
5,
Roche Laboratories, Inc.,
5,
Savient Pharmaceuticals, Inc.,
5,
Sun Pharmaceutical Industries Ltd.,
5,
UCB, Inc.,
5;
R. Landewé,
Abbott/AbbVie, Ablynx, Amgen, AstraZeneca, BMS, GSK, Janssen, Novartis, Merck, Pfizer, UCB,
2,
Abbott/AbbVie, Ablynx, Amgen, AstraZeneca, BMS, GSK, Janssen, Novartis, Merck, Pfizer, UCB,
5;
E. L. Matteson,
Hoffmann-La Roche, Inc.,
2,
Pfizer Inc,
2,
Novartis Pharmaceutical Corporation,
2,
Mesoblast,
2,
UCB Pharma,
2,
Genentech and Biogen IDEC Inc.,
2,
Celegene,
2,
Ardea Biosciences,
2;
N. B. Gaylis,
Janssen Research & Development, LLC.,
9;
J. Wollenhaupt,
AbbVie, Biotest, MSD, Pfizer,
5,
AbbVie, MSD, Pfizer,
8,
Janssen Research & Development, LLC.,
9;
F. T. Murphy,
AbbVie,
8,
Janssen Research & Development, LLC.,
9;
C. Han,
Janssen Global Services, LLC.,
3;
T. A. Gathany,
Janssen Global Services, LLC,
3;
S. Xu,
Janssen Research & Development, LLC.,
3;
Y. Zhou,
Janssen Research & Development, LLC.,
3;
E. C. Hsia,
Janssen Research & Develpment, LLC.,
3;
M. K. Doyle,
Janssen Research & Development, LLC.,
3.
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