Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Final 5yr safety and efficacy results of subcutaneous golimumab (GLM)+/-MTX evaluated in a phase 3 trial (GO-BEFORE) of MTX-naïve pts with rheumatoid arthritis (RA) are reported.
Methods: Pts in GO-BEFORE were randomized to placebo(PBO)+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 28 (blinded early escape) or 52 (pts with ≥1 swollen/tender joint). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, PBO+MTX pts could switch to GLM 50mg+MTX, MTX and corticosteroid use could be adjusted, and a one-time GLM dose change (50 à100mg or 100 à50mg) was permitted at investigator’s discretion. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively.
Results: Of 637 randomized pts, 3 were never treated; 419 continued treatment through wk252, and 215 pts withdrew (111 for AE, 23 for lack of efficacy, 20 lost to follow-up, 53 for other reasons, 8 deaths). 402 pts completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk 256, 84.3% of all pts had an ACR20, 93.9% had DAS28-CRP EULAR response, and 80.6% had improvement in HAQ-DI ≥0.25. Mean changes from baseline in total vdH-S score were small and 64% of pts randomized to GLM+MTX had no radiographic progression (DvdH-S≤0). The most common AEs were upper respiratory tract infection(29.4%), nausea(19.6%), bronchitis(16.6%), and increased alanine aminotransferase (16.1%); 11.9% of pts had an injection-site reaction. Through wk268, 204/616 (33.1%) pts had an SAE; 17.5% of pts discontinued study agent due to AEs. Overall rates of serious infections, malignancies, and death were 12.2%, 3.4%, and 1.9%, respectively. Of 595 pts with available samples, 58 (9.7%) were positive for antibodies to GLM.
Conclusion: The retention rate was high (66.1%) through 5yrs. GLM+MTX therapy resulted in maintained improvements in signs/symptoms of RA and in physical function, and inhibited structural damage progression long-term. No new safety signals were detected through 5years in MTX-naïve RA pts.
Table. Efficacy results at wk256.
|
Efficacy results at wk256 |
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|
|
PBO+MTXa,b |
GLM 100mg+PBOb |
GLM 50mg+MTXb |
GLM 100mg+MTXb |
Total |
|
ACR20 |
87/110 (79.1%) |
89/105 (84.8%) |
92/108 (85.2%) |
87/98 (88.8%) |
355/421 (84.3%) |
|
ACR50 |
68/110 (61.8%) |
68/105 (64.8%) |
72/108 (66.7%) |
73/98 (74.5%) |
281/421 (66.7%) |
|
ACR70 |
53/110 (48.2%) |
47/105 (44.8%) |
47/108 (43.5%) |
52/98 (53.1%) |
199/421 (47.3%) |
|
DAS28-CRP EULAR Response |
96/106 (90.6%) |
98/103 (95.1%) |
99/106 (93.4%) |
94/97 (96.9%) |
387/412 (93.9%) |
|
DAS28-CRP <2.6 |
56/106 (52.8%) |
50/103 (48.5%) |
59/106 (55.7%) |
60/97 (61.9%) |
225/412 (54.6%) |
|
SDAI ≤3.3 |
42/106(39.6%) |
33/103(32.0%) |
35/106(33.0%) |
38/98(38.8%) |
148/413(35.8%) |
|
HAQ-DI improvement ≥0.25 |
90/109 (82.6%) |
86/104 (82.7%) |
78/106 (73.6%) |
83/99 (83.8%) |
337/418 (80.6%) |
|
Radiographic results at wk256 |
|||||
|
Estimated annual progression rate at baselinec |
8.8 ± 20.2 |
8.8 ± 29.0 |
10.1 ± 26.2 |
6.8 ± 14.9 |
8.6 ± 23.2 |
|
Mean ± SD annual rate of progression through 5yrsd |
0.5 ±1.5 |
0.3 ± 1.3 |
0.2 ± 0.8 |
0.1 ± 0.6 |
0.3 ± 1.1 |
|
Mean ± SD change in vdH-S score |
2.3 ± 6.7 |
1.8 ± 6.8 |
0.7 ± 3.7 |
0.6 ± 2.9 |
1.4 ± 5.3 |
|
Change in vdH-S score ≤0 |
65/120 (54.2%) |
64/113 (56.6%) |
75/120 (62.5%) |
73/112 (65.2%) |
277/465 (59.6%) |
|
aPts randomized to PBO who switched to GLM at wk28 or 52. bAfter wk52 pts could receive GLM50 mg or 100mg, and MTX could be added/adjusted. cEstimated as vdH-S score divided by the disease duration per pt. dEstimated as change in vdH-S score divided by GLM treatment duration per pt. |
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Disclosure:
P. Emery,
Pfizer, Roche, BMS, AbbVie, UCB, MSD,
8,
Pfizer, Roche, BMS, AbbVie, UCB, MSD,
5;
R. Fleischmann,
Janssen Research & Development, LLC.,
2;
I. Strusberg,
Janssen Research & Development, LLC.,
2,
AstraZeneca, BMS,
8;
P. Durez,
BMS, Pfizer, Samsung,
8,
Janssen Research & Development, LLC.,
9;
P. Nash,
Janssen Research & Development, LLC.,
8,
Janssen Research & Development, LLC.,
9;
E. Amante,
Janssen Resarch & Development, LLC.,
9;
M. A. Churchill,
AbbVie, Warner Chilcott, Takeda,
8,
Janssen Research & Development, LLC.,
9;
W. Park,
Janssen Research & Development, LLC.,
9;
B. Pons-Estel,
Janssen Research Development,
2;
C. Han,
Janssen Global Services, LLC.,
3;
T. A. Gathany,
Janssen Global Services, LLC,
3;
Y. Zhou,
Janssen Research & Development, LLC.,
3;
S. Xu,
Janssen Research & Development, LLC.,
3;
E. C. Hsia,
Janssen Research & Develpment, LLC.,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/final-5-year-safety-and-efficacy-results-of-a-phase-3-randomized-placebo-controlled-trial-of-golimumab-in-methotrexate-naive-patients-with-rheumatoid-arthritis/