Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Assess safety and efficacy of GLM+MTX over 1yr in a multicenter, randomized, placebo (PBO)-controlled study of Chinese pts with active RA despite MTX therapy.
Methods: 264 pts were randomized (1:1) to subcutaneous PBO+MTX (Group1) or GLM 50mg+MTX (Group2) q4wks. All pts received stable doses of oral MTX (7.5-20mg/wk). Group1 pts with inadequate treatment response entered blinded early escape to GLM 50mg+MTX at wk16. All remaining Group1 pts switched to GLM 50mg+MTX at wk24. Blinding to randomization assignment was maintained through wk 56. The last GLM injection was at wk48; the last efficacy assessment was wk52. The primary endpoint was ACR20 at wk14. Efficacy assessments included DAS28-CRP, HAQ-DI, SF-36 PCS and MCS, and FACIT-Fatigue scores. Adverse events (AEs) were monitored through wk56.
Results: Baseline demographics and disease characteristics were generally similar between the groups; median age was 49 yrs and 81.1% of pts were female. 23 (8.7%) pts discontinued treatment through wk56. Efficacy results are shown in the table. At wk14, 15.9% of Group1 pts and 40.9% of Group2 pts had ACR20 response (p<0.001). At wk24, Group2 pts had significantly greater improvements in DAS28-CRP, SF-36 PCS and MCS scores, and FACIT-fatigue score. A greater proportion of Group2 pts had HAQ-DI improvement ≥0.25 vs. Group1. The responses to GLM+MTX therapy were maintained through wk52 in Group2; after switching to GLM, Group1 pts also achieved rapid improvement. Through wk16, 23.5% of Group1 pts and 26.7% of Group2 pts reported AEs (infections were the most common); 0.8% and 1.5% reported serious AEs. Through wk56, 130/259 (50.2%) of GLM+MTX-treated pts had an AE, and 11/259 (4.2%) had an SAE. 3 serious infections (pneumonia, lung infection, respiratory tract infection) and 1 death (acute myocardial infarction) occurred in GLM+MTX-treated pts. No malignancies or opportunistic infections were reported. Only 1 pt had an injection site reaction (mild pain).Of the 251 GLM+MTX-treated pts with available samples, 6 (2.4%) were positive for antibodies to GLM through wk52.
Conclusion: Among Chinese pts with RA, GLM+MTX-treated pts had significantly greater improvements in RA signs/symptoms vs. PBO+MTX-treated pts through wk24, and responses were maintained through wk52. GLM+MTX was well tolerated and no unexpected safety events occurred through wk56. In Chinese pts, GLM+MTX demonstrated efficacy and acceptable safety similar to that in a global population in the GO-FORWARD trial.
Table. Efficacy results through week 52.
|
|
PBO+MTX / GLM 50 mg+MTX (n = 132) |
GLM 50 mg +MTX (n = 132) |
|
Wk24 |
|
|
|
ACR20 |
21 (15.9%) |
56 (42.4%)** |
|
DAS28-CRP, Mean±SD change from baseline |
-0.2 ± 1.5 |
-1.2 ± 1.3** |
|
HAQ-DI improvement ≥ 0.25 |
39 (29.5%) |
65 (49.2%)* |
|
SF-36 PCS, Mean±SD change from baseline |
-0.88 ± 6.92 |
4.30 ± 7.05** |
|
SF-36 MCS, Mean±SD change from baseline |
-2.68 ± 12.07 |
2.23 ± 10.59** |
|
FACIT-F, Mean±SD change from baselinea |
-2.2 ± 11.2 |
3.4 ± 9.4** |
|
Wk52 |
|
|
|
ACR20 |
75 (56.8%) |
92 (69.7%) |
|
DAS28-CRP, Mean±SD change from baseline |
-2.0 ± 1.4 |
-2.2 ± 1.4 |
|
HAQ-DI improvement ≥ 0.25 |
65 (49.2%) |
87 (65.9%) |
|
SF-36 PCS, Mean±SD change from baseline |
3.6 ± 7.1 |
6.8 ± 8.9 |
|
SF-36 MCS, Mean±SD change from baseline |
0.2 ± 9.8 |
3.9 ± 11.0 |
* p = 0.001, ** p < 0.001
a No assessments past wk24.
Disclosure:
Z. Li,
Janssen Research & Development, LLC.,
9;
F. Zhang,
Janssen Research & Development, LLC.,
9;
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;
K. Fei,
Janssen Research & Development, LLC.,
3;
C. Han,
Janssen Global Services, LLC.,
3;
Y. Zhuang,
Janssen Research & Development, LLC.,
3;
Z. Wu,
Janssen Research & Development, LLC.,
3;
E. C. Hsia,
Janssen Research & Develpment, LLC.,
3.
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