POS0269 RESULTS OF ONE YEAR OBSERVATIONAL EXTENSION OF THE BRIDGE-PMR STUDY, A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED TRIAL WITH RITUXIMAB IN POLYMYALGIA RHEUMATICA
Background Glucocorticoids (GC) are the cornerstone of treatment in Polymyalgia rheumatica (PMR) [1]. However, they are associated with considerable toxicity and inefficacy in part of the patients. Rituximab (RTX) was effective for PMR in a 21-week randomized controlled trial (RCT), however results...
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Published in | Annals of the rheumatic diseases Vol. 81; no. Suppl 1; pp. 377 - 378 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
01.06.2022
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Online Access | Get full text |
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Summary: | Background
Glucocorticoids (GC) are the cornerstone of treatment in Polymyalgia rheumatica (PMR) [1]. However, they are associated with considerable toxicity and inefficacy in part of the patients. Rituximab (RTX) was effective for PMR in a 21-week randomized controlled trial (RCT), however results from longer follow-up is still absent [2].
Objectives
To assess, in a randomized double blinded fashion, the clinical and GC-sparing effects one year after RTX.
Methods
In the BRIDGE-PMR, an RCT of 38 recently diagnosed and 9 relapsing PMR (2012 EULAR/ACR classification criteria) patients recruited from the Sint Maartenskliniek, patients were randomly allocated in a 1:1 ratio and treated with 1x 1000mg RTX / placebo (PCB) iv, identical pre-medication and an accelerated GC tapering protocol. After the 21-week study, patients were assessed in a double blinded prospective extension study up to one year after infusion. The primary outcome at one year was between group difference in GC-free remission (PMR-activity score < 10). Analysis was performed with Fischer’s exact test and a two-tailed p-value < 0.05 was considered significant. Secondary outcomes were proportion of relapsing patients during the extension, proportion of patients with CRP > 5mg/l during the extension, cumulative GC dose, DMARD use, EQ-5D score, and adverse events (AE).
Results
The proportion of patients in GC-free remission after one year was significantly higher in the RTX group (48%, 11/23) compared to the PCB group (17%, 4/24), with an absolute difference of 31% (95%-CI 6-56), a relative risk of 2.9 (95%-CI 1.1-7.7), p=0.03. The secondary outcomes showed statistically significant differences in RTX versus PCB in median GC cumulative dose: 1595 versus 2302 mg (p = 0.04) and median PMR-AS: 6 versus 15 (p = 0.02) (Table 1 and Figure 1). No differences were seen in other secondary outcomes.
Table 1.
Primary and Secondary Outcomes for Rituximab Versus Placebo Treatment One Year After Infusion
Placebo [n=24]
Rituximab [n=23]
p-value
Remission, number (%)
10 (42%)
15 (65%)
0.15
GC-free remission, number (%)
4 (17%)
11 (48%)
0.03
Cumulative GC dose 0-52 weeks, in mg
2302 (1595 - 2881)
1595 (1275 – 2260)
0.04
Cumulative GC dose 21-52 weeks, in mg
959 (91 – 1442)
160 (0 - 902)
0.10
Relapse patient 21-52 weeks, number (%)*
14 (58%)
12 (52%)
0.77
PMR-AS**
15.25 (7.75 - 22.5)
6.3 (4.7 - 12.1)
0.02
CRP serum level, in mg/L
3.5 (2 - 5)
3 (1 - 4)
0.29
physicians’ VAS, 0-10
2 (0.2 - 3.7)
1 (0 - 2)
0.08
Morning stiffness, in minutes
25 (4 - 60)
10 (0 - 30)
0.06
VAS pain, 0-10
3 (1.45 - 6.4)
1.8 (0.7 - 5)
0.16
EQ5D-5L, score at week 52#
0.71 (0.65 – 0.77)
0.71 (0.63 – 0.77)
0.87
EQ5D-5L, change week 21-52#
0 (-0.03 - 0.09)
0.07 (-0.05 - 0.10)
0.56
Methotrexate use, number (%)
4 (17%)
2 (9%)
0.67
Adverse events, total, % of patients
8, 26%
6, 33%
0.75
Notes
. * Relapse was defined as therapy intensification, based on either a) an increase in oral prednisolone, b) adding intramuscular methylprednisolone, or c) starting or switching a DMARD due to treatment inefficiency ** Remission is based on the PMR-AS, calculated by CRP +VASp +VASph + (MST *0.1) + EUL, and a PMR-AS < 10 was considered remission or low disease-activity. # Number of patients for placebo versus RTX were n=23 versus n=23 respectively at week 52, and for comparison of change between week 21-52 total number of patients were n=21 versus n=23 respectively
Figure 1.
Cumulative GC Dose 0-52 Weeks, in mg
Conclusion
Efficacy of 1x1000 mg RTX in PMR was maintained up to 1 year follow-up, while also demonstrating a GC sparing effect. A larger trial, also assessing effect of on demand retreatment, is needed to confirm our results, and provide insight in which patients most likely benefit from RTX.
References
[1]Dejaco C, et al. Ann Rheum Dis 2015;74(10):1799-807. doi: 10.1136/annrheumdis-2015-207492
[2]Marsman DE, et al. The Lancet Rheumatology 2021;3(11):e758-e66. doi: 10.1016/S2665-9913(21)00245-9
Disclosure of Interests
None declared |
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ISSN: | 0003-4967 1468-2060 |
DOI: | 10.1136/annrheumdis-2022-eular.1797 |