Session Information
Session Type: Abstract Submissions (ACR)
Prevention of radiological progression in patients with primary knee osteoarthritis with Strontium Ranelate
Background/Purpose: Strontium ranelate (SrRan) has demonstrated a structure-modifying activity with symptomatic improvement in patients with knee osteoarthritis (OA). This analysis aimed to compare the proportion of patients in whom radiological OA progression was prevented between groups, considering different cut-offs of JSN.
Methods: SEKOIA study included patients with symptomatic primary knee OA (Kellgren and Lawrence [KL] grade 2 or 3, JSW:2.5–5 mm) randomly allocated to SrRan 1 or 2 g/day or placebo. Primary endpoint was JSW radiographic change over 3 years in the medial compartment. JSW was measured yearly with validated computer-assisted centralized reading method. Patients with no relevant radiological OA progression were defined as those with a JSW loss from baseline to End, lower than 0.1mm, 0.2 mm or 0.3 mm. Patients who withdrew from the study were counted as non-responder. Treatment groups were compared to placebo using a chi² test.
Results: ITT set included 1371 (82% of the randomized set) patients. Age was 63±7 years, BMI was 30±5 kg/m2, JSW was 3.5±0.8 mm. 61% were KL II. 69% were female. A significantly greater proportion of patients in SrRan1g and 2g groups had no radiological progression compared to placebo: 40.5% and 44.1% vs. 32.8% (p=0.017 and p<0.01) with the 0.3 mm threshold. It corresponds to a proportion of responders increased by 24% and 34% in the SrRan 1g and 2g groups compared to placebo, with a number of patients needed to be treated (NNT) of 13 and 9. Similar results were observed at additional JSN cut-offs:
|
|
Strontium ranelate 1 g (N = 445) |
Strontium ranelate 2 g (N = 454) |
Placebo (N = 472) |
|
Responders : JSN ≥– 0.1 mm |
|
|
|
|
Patients who responded, n (%) |
130 (29.21) |
136 (29.96) |
101 (21.40) |
|
p-value |
0.006 |
0.003 |
|
|
RRR |
36.0 |
40.0 |
|
|
NNT |
13 |
12 |
|
|
Responders : JSN ≥-0.2 mm |
|
|
|
|
Patients who responded, n (%) |
161 (36.18) |
173 (38.11) |
133 (28.18) |
|
p-value |
0.009 |
0.001 |
|
|
RRR |
28.4 |
35.2 |
|
|
NNT |
13 |
10 |
|
|
Responders : JSN ≥– 0.3 mm |
|
||
|
Patients who responded, n (%) |
180 (40.5) |
200 (44.05) |
155 (32.80) |
|
p-value |
0.017 |
<0.001 |
|
|
RRR |
23.5 |
34.3 |
|
|
NNT |
13 |
9 |
|
Conclusion: Treatment with SrRan is associated with a significantly greater number of patients without OA radiological progression over 3 years.
Disclosure:
J. Y. Reginster,
Servier, Novartis, Negma, Lilly, Wyeth, Amgen, GlaxoSmithKline, Roche, Merckle, Nycomed, NPS, Theramex, UCB,
5,
Merck Sharp and Dohme, Lilly, Rottapharm, IBSA, Genevrier, Novartis, Servier, Roche, GlaxoSmithKline, Teijin, Teva, Ebewee Pharma, Zodiac, Analis, Theramex, Nycomed, Novo-Nordisk,
9,
Bristol Myers Squibb, Merck Sharp and Dohme, Rottapham, Teva, Lilly Novartis, Roche, GlaxiSmithKline, Amgen, Servier,
2;
R. Chapurlat,
Servier,
2;
F. Berenbaum,
Servier,
2;
P. Nash,
Servier,
5;
O. Zamani,
None;
M. Cohen-Solal,
Servier,
5;
G. Bianchi,
Servier,
5;
J. Branco,
Servier,
5;
F. Navarro,
None;
C. Cooper,
Amgen, ABBH,Novartis, Pfizer, Merck Sharp and Dohme, Eli Lilly, Servier,
5.
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