Tags

Type your tag names separated by a space and hit enter

A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial).
Semin Arthritis Rheum. 2009 Aug; 39(1):1-9.SA

Abstract

OBJECTIVE

To report the FLEXX trial, the first well-controlled study assessing the safety and efficacy of Euflexxa (1% sodium hyaluronate; IA-BioHA) therapy for knee osteoarthritis (OA) at 26 weeks.

METHODS

This was a randomized, double-blind, multicenter, saline-controlled study. Subjects with chronic knee OA were randomized to 3 weekly intra-articular (IA) injections of either buffered saline (IA-SA) or IA-BioHA (20 mg/2 ml). The primary efficacy outcome was subject recorded difference in least-squares means between IA-BioHA and IA-SA in subjects' change from baseline to week 26 following a 50-foot walk test, measured via 100-mm visual analog scale (VAS). Secondary outcome measures included Osteoarthritis Research Society International responder index, Western Ontario McMaster University Osteoarthritis Index VA 3.1 subscales, patient global assessment, rescue medication, and health-related quality of life (HRQoL) by the SF-36. Safety was assessed by monitoring and reporting vital signs, physical examination of the target knee following injection, adverse events, and concomitant medications.

RESULTS

Five hundred eighty-eight subjects were randomized to either IA-BioHA (n = 293) or IA-SA (n = 295), with an 88% 26 week completion rate. No statistical differences were noted between the treatment groups at baseline. In the IA-BioHA group, mean VAS scores decreased by 25.7 mm, compared with 18.5 mm in the IA-SA group. This corresponded to a median reduction of 53% from baseline for IA-BioHA and a 38% reduction for IA-SA. The difference in least-squares means was -6.6 mm (P = 0.002). Secondary outcome measures were consistent with significant improvement in Osteoarthritis Research Society International responder index, HRQoL, and function. Both IA-SA and IA-BioHA injections were well tolerated, with a low incidence of adverse events that were equally distributed between groups. Injection-site reactions were reported by 1 (<1%) subject in the IA-SA group and 2 (1%) in the IA-BioHA group.

CONCLUSIONS

IA-BioHA therapy resulted in significant OA knee pain relief at 26 weeks compared with IA-SA. Subjects treated with IA-BioHA also experienced significant improvements in joint function, treatment satisfaction, and HRQoL.

Authors+Show Affiliations

Division of Rheumatology and Immunology, University of California Los Angeles, Los Angeles, CA 90095, USA. journals@royaltman.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19539353

Citation

Altman, Roy D., et al. "A Double-blind, Randomized, Saline-controlled Study of the Efficacy and Safety of EUFLEXXA for Treatment of Painful Osteoarthritis of the Knee, With an Open-label Safety Extension (the FLEXX Trial)." Seminars in Arthritis and Rheumatism, vol. 39, no. 1, 2009, pp. 1-9.
Altman RD, Rosen JE, Bloch DA, et al. A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Semin Arthritis Rheum. 2009;39(1):1-9.
Altman, R. D., Rosen, J. E., Bloch, D. A., Hatoum, H. T., & Korner, P. (2009). A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). Seminars in Arthritis and Rheumatism, 39(1), 1-9. https://doi.org/10.1016/j.semarthrit.2009.04.001
Altman RD, et al. A Double-blind, Randomized, Saline-controlled Study of the Efficacy and Safety of EUFLEXXA for Treatment of Painful Osteoarthritis of the Knee, With an Open-label Safety Extension (the FLEXX Trial). Semin Arthritis Rheum. 2009;39(1):1-9. PubMed PMID: 19539353.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A double-blind, randomized, saline-controlled study of the efficacy and safety of EUFLEXXA for treatment of painful osteoarthritis of the knee, with an open-label safety extension (the FLEXX trial). AU - Altman,Roy D, AU - Rosen,Jeffrey E, AU - Bloch,Daniel A, AU - Hatoum,Hind T, AU - Korner,Paul, Y1 - 2009/06/17/ PY - 2009/02/02/received PY - 2009/04/05/revised PY - 2009/04/11/accepted PY - 2009/6/23/entrez PY - 2009/6/23/pubmed PY - 2009/10/13/medline SP - 1 EP - 9 JF - Seminars in arthritis and rheumatism JO - Semin. Arthritis Rheum. VL - 39 IS - 1 N2 - OBJECTIVE: To report the FLEXX trial, the first well-controlled study assessing the safety and efficacy of Euflexxa (1% sodium hyaluronate; IA-BioHA) therapy for knee osteoarthritis (OA) at 26 weeks. METHODS: This was a randomized, double-blind, multicenter, saline-controlled study. Subjects with chronic knee OA were randomized to 3 weekly intra-articular (IA) injections of either buffered saline (IA-SA) or IA-BioHA (20 mg/2 ml). The primary efficacy outcome was subject recorded difference in least-squares means between IA-BioHA and IA-SA in subjects' change from baseline to week 26 following a 50-foot walk test, measured via 100-mm visual analog scale (VAS). Secondary outcome measures included Osteoarthritis Research Society International responder index, Western Ontario McMaster University Osteoarthritis Index VA 3.1 subscales, patient global assessment, rescue medication, and health-related quality of life (HRQoL) by the SF-36. Safety was assessed by monitoring and reporting vital signs, physical examination of the target knee following injection, adverse events, and concomitant medications. RESULTS: Five hundred eighty-eight subjects were randomized to either IA-BioHA (n = 293) or IA-SA (n = 295), with an 88% 26 week completion rate. No statistical differences were noted between the treatment groups at baseline. In the IA-BioHA group, mean VAS scores decreased by 25.7 mm, compared with 18.5 mm in the IA-SA group. This corresponded to a median reduction of 53% from baseline for IA-BioHA and a 38% reduction for IA-SA. The difference in least-squares means was -6.6 mm (P = 0.002). Secondary outcome measures were consistent with significant improvement in Osteoarthritis Research Society International responder index, HRQoL, and function. Both IA-SA and IA-BioHA injections were well tolerated, with a low incidence of adverse events that were equally distributed between groups. Injection-site reactions were reported by 1 (<1%) subject in the IA-SA group and 2 (1%) in the IA-BioHA group. CONCLUSIONS: IA-BioHA therapy resulted in significant OA knee pain relief at 26 weeks compared with IA-SA. Subjects treated with IA-BioHA also experienced significant improvements in joint function, treatment satisfaction, and HRQoL. SN - 1532-866X UR - https://www.unboundmedicine.com/medline/citation/19539353/A_double_blind_randomized_saline_controlled_study_of_the_efficacy_and_safety_of_EUFLEXXA_for_treatment_of_painful_osteoarthritis_of_the_knee_with_an_open_label_safety_extension__the_FLEXX_trial__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-0172(09)00039-0 DB - PRIME DP - Unbound Medicine ER -