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Abstract Number: 249

A Phase 3 Open-Label Trial of Low-Dose Solumatrix Diclofenac in Patients with Osteoarthritis Pain: Impact of Long-Term Administration on Patient-Reported Outcomes

Vibeke Strand1, Allan Gibofsky2, Marc Hochberg3, Roy Altman4, Byron Cryer5, Alan Kivitz6, Olaolu Imasogie7 and Clarence Young8, 1Stanford University, Palo Alto, CA, 2Medicine and Public Health, Hospital for Special Surgery, New York, NY, 3University of Maryland School of Medicine, College Park, MD, 4University of California–Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 5University of Texas Southwestern Medical Center, Dallas, TX, 6Altoona Center for Clinical Research, Duncansville, PA, 7Iroko Pharmaceuticals LLC, Philadelphia, PA, 8150 Rouse Boulevard, Iroko Pharmaceuticals, LLC, Phila, PA

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Nonsteroidal antiinflammatory drugs (NSAIDs), Osteoarthritis, pain and pain management

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Session Information

Title: Pain: Basic and Clinical Aspects

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

 

 

 

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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