Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Diclofenac is used for the treatment of osteoarthritis (OA), but, like other NSAIDs, it is associated with serious dose-related adverse events. The FDA has encouraged providers to prescribe NSAIDs at the lowest effective dose. SoluMatrix® diclofenac was developed to provide efficacy at low doses and is approved for treatment of mild to moderate acute pain in adults. A 1-year, open-label, multicenter, phase 3 study in patients with OA evaluated the safety and patient–reported outcome measures associated with SoluMatrix diclofenac.
Methods: The study treated 601 patients age≥40, with knee and/or hip OA, who were chronic NSAID/acetaminophen users. Patients initially received SoluMatrix diclofenac 35-mg capsules BID. The dose could be increased to TID, and subsequently reduced back to BID as needed. Health-related quality of life (HRQOL) was evaluated by the Short Form-36TM version 2 (SF-36v2), which was completed at baseline and at weeks 12, 24, 32, 40, 48; and 52/early termination visit (ET).
Results: During the study, 299/601 (49.8%) patients remained on the SoluMatrix diclofenac 35-mg BID and 302/601 (50.2%) patients increased their SoluMatrix diclofenac dosage to 35-mg TID at least once (316 events), mostly due to the need for more analgesia (214/316, 67.7% events). In total, 20.6% (65/316) of the dosing increases from BID to TID were reduced back to BID, mainly due to satisfactory analgesia (21/65, 32.3%). Patients receiving SoluMatrix diclofenac treatments reported clinically meaningful improvement (≥2.5) in SF-36v2 Physical Component Score from baseline at 12 throughout 52 weeks dosing period (Table). Based on values that exceed normative scores at baseline, SF-36v2 Mental Component Scores were not expected to improve (Table). Clinically meaningful improvements from baseline to week 52/ET (≥5) were reported for the SF-36v2 Bodily Pain domain scores (+5.5). Improvements in Physical Functioning (+4.3) and Role Physical (+3.6) were also observed (Table). Only 12 patients (2%) withdrew from the study due to lack of efficacy.
Conclusion: Low-dose SoluMatrix diclofenac capsules 35-mg BID or TID were associated with improved HRQOL in patients with OA pain and represent a potentially promising treatment option for these patients.
Table.
|
SoluMatrix Diclofenac 35 mg BID and TID Combined |
|||
|
|
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|
|
Baseline |
Week 52/ET |
Change From Baseline to Week 52/ET |
|
Number of Patients |
601 |
555 |
– |
|
SF-36v2 Physical Component Score Mean (SD) |
39.5 (7.72) |
44.2 (8.29) |
4.5 (6.89)a |
|
SF-36v2 Mental Component Score Mean (SD) |
52.0 (9.60) |
52.3 (9.44) |
0.1 (8.41) |
|
SF-36v2 Domain Scores Mean (SD) |
Baseline |
Week 52/ET |
Change From Baseline to Week 52/ET |
|
Physical Functioning |
37.8 (8.64) |
42.2 (9.48) |
4.3 (8.14) |
|
Role Physical |
41.3 (8.64) |
45.1 (8.79) |
3.6 (7.99) |
|
Bodily Pain |
40.1 (6.72) |
45.8 (8.27) |
5.5 (8.55)b |
|
General Health |
51.2 (8.87) |
51.5 (8.97) |
0.1 (6.04) |
|
Vitality |
48.1 (8.89) |
50.4 (9.25) |
2.3 (8.00) |
|
Social Functioning |
46.5 (9.43) |
48.9 (9.12) |
2.1 (8.97) |
|
Role Emotional |
45.2 (10.57) |
47.1 (10.22) |
1.5 (10.04) |
|
Mental Health |
51.2 (8.71) |
51.9 (9.19) |
0.5 (8.06) |
BID= twice daily; ET = early termination; TID= three times daily
aChange from baseline in scores ≥ minimally clinically important difference (MCID) ≥2.5 for physical component score.
bChange from baseline in scores ≥ minimally clinically important difference (MCID) ≥5.0 for SF-36v2
domain scores.
Disclosure:
V. Strand,
Consultant for AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, CORRONA, Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB, Vertex,
5;
A. Gibofsky,
Stock shareholder of GlaxoSmithKline plc, Bristol-Myers Squibb, Johnson & Johnson, Amgen, Pfizer, AbbVie, Johnson and Johnson ,
1,
consultant for Takeda, Amgen, AbbVie, UCB Inc., Genentech, Horizon, and Iroko Pharmaceuticals LLC,
5;
M. Hochberg,
Consultant for Iroko Pharmaceuticals LLC, Amgen, AstraZeneca, Covidien, Eli Lilly, EMD Serono, Genentech/Roche, Merck & Co, Inc., Novartis Pharma AG, Pfizer, and Pozen,
5;
R. Altman,
Participant in advisory boards for Iroko Pharmaceuticals, consultant to Pfizer, Teva Pharmaceutical Industries Ltd., Petah Tikva, Oletec, Novartis, Johnson & Johnson, consultant and member of the speaker’s bureau for Ferring Pharmaceuticals ,
5;
B. Cryer,
: Consulting fees received from Ritter Pharmaceuticals, Sanofi, Sandoz, Sucempo, and Iroko Pharmaceuticals, LLC,
5;
A. Kivitz,
Iroko Pharmaceuticals LLC,
5;
O. Imasogie,
IBoko Pharmaceuticals LLC,
3;
C. Young,
Iroko Pharmaceuticals, LLC,
3.
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