326 Effectiveness and Safety of a Single Intraarticular Injection of Gel-200, a New Cross-Linked Formulation of Hyaluronic Acid [Ha] in the Treatment of Symptomatic Osteoarthritis [Oa] of the Knee

Baraf, Herbert S. B.; Strand, Vibeke; Hosokawa, Hiroyuki; Akahane, O.; Lim, Sang Yup; Yaguchi, Masafumi

doi:10.1016/s1063-4584(09)60348-4

Cited by 5 publications

(4 citation statements)

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“…An additional three were the sources of the previously mentioned unreported proprietary data; four presented SAEs without additional specification of what qualified as an SAE [64, 68–70]; two presented what they included as SAEs in aggregate but not by treatment group [71, 72]; one reported a mix of specific and nonspecific SAEs [73]; and for one, we were unable to find the original article because the journal is out of print and the authors did not respond to our queries [74]. …”

Section: Resultsmentioning

confidence: 99%

“…Instances of cases where AEs were excluded because the author did not designate it as serious includes deaths from myocardial infarction in both intervention [54] and control [75] patients, four cases of “severe” knee swelling [54], one case of cerebral hemorrhage in the control group [26], and one case of breast cancer in the control group [75]. This adoption of the author’s designation of seriousness also results in the inclusion of four cancers as relevant SAEs in the course of a 13-week study [73]. …”

Section: Resultsmentioning

confidence: 99%

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Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews

et al. 2016

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BackgroundThe prevalence of knee osteoarthritis (OA)/degenerative joint disease (DJD) is increasing in the USA. Systematic reviews of treatment efficacy and adverse events (AEs) of hyaluronic acid (HA) injections report conflicting evidence about the balance of benefits and harms. We review evidence on efficacy and AEs of intraarticular viscosupplementation with HA in older individuals with knee osteoarthritis and account for differences in these conclusions from another systematic review.MethodsWe searched PubMed and eight other databases and gray literature sources from 1990 to December 12, 2014. Double-blind placebo-controlled randomized controlled trials (RCTs) reporting functional outcomes or quality-of-life; RCTs and observational studies on delay/avoidance of arthroplasty; RCTs, case reports, and large cohort studies and case series assessing safety; and systematic reviews reporting on knee pain were considered for inclusion.A standardized, pre-defined protocol was applied by two independent reviewers to screen titles and abstracts, review full text, and extract details on study design, interventions, outcomes, and quality. We compared our results with those of a prior systematic review and found them to be discrepant; our analysis of why this discrepancy occurred is the focus of this manuscript.ResultsEighteen RCTs reported functional outcomes: pooled analysis of ten placebo-controlled, blinded trials showed a standardized mean difference of −0.23 (95 % confidence interval (CI) −0.45 to −0.01) favoring HA at 6 months. Studies reported few serious adverse events (SAEs) and no significant differences in non-serious adverse events (NSAEs) (relative risk (RR) [95 % CI] 1.03 [0.93–1.15] or SAEs (RR [95 % CI] 1.39 [0.78–2.47]). A recent prior systematic review reported similar functional outcomes, but significant SAE risk. Differences in SAE inclusion and synthesis accounted for the disparate conclusions.ConclusionsTrials show a small but significant effect of HA on function on which recent systematic reviews agree, but lack of AE synthesis standardization leads to opposite conclusions about the balance of benefits and harms. A limitation of the re-analysis of the prior systematic review is that it required imputation of missing data.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-016-0363-9) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews

et al. 2016

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“…Industry involvement was reported in 53 trials (98%) either in the form of funding, providing statistical analyses or having an industry member as a co-author. Forty-five trials (83%) were published as full-text journal articles, five trials were published as abstracts only 38,40,42,50,61 , and three were unpublished 48,54 .One recent trial was reported as an abstract 20 , which we expect to see as full-text publication in the near future. In addition, an unpublished and unreported trial (382 participants) was identified in the Orthovisc Ò package insert as OAK 9801.…”

Section: Risk Of Bias Within Trialsmentioning

confidence: 99%

Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis – meta-analysis

Bannuru

Natov

Dasi

et al. 2011

Osteoarthritis and Cartilage

359

250

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Our meta-analysis highlights a therapeutic trajectory of IAHA for knee OA pain over 6 months post-intervention. With this additional perspective, we are able to infer that IAHA is efficacious by 4 weeks, reaches its peak effectiveness at 8 weeks and exerts a residual detectable at 24 weeks. On the other hand, the peak effect size (0.46; 0.28, 0.65), is greater than published effects from other OA analgesics [acetaminophen (ES=0.13; 0.04, 0.22); NSAIDs (ES=0.29; 0.22, 0.35); COX-2 inhibitors (ES=0.44; 0.33, 0.55)]. An effect size above 0.20 is considered to be clinically relevant on an individual patient basis in chronic pain conditions such as knee OA. Thus, its properties could have utility for certain clinical situations, or in combination with other therapies.

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“…Values reflect decrements in HRQOL comparable to those reported by subjects with longstanding, debilitating RA, or active SLE 36. In contrast, osteoarthritis appears exclusively to impact PF, RP and BP domains, with preservation of other scores, including VT (fatigue)37 (fig 3B). …”

Section: Sf-36 Spydergram In Different Rheumatic Diseasesmentioning

confidence: 98%

Use of “spydergrams” to present and interpret SF-36 health-related quality of life data across rheumatic diseases

Strand

Crawford²,

Singh

et al. 2009

Annals of the Rheumatic Diseases

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The Medical Outcomes Study Short Form-36 (SF-36) is a generic measure of health-related quality of life (HRQOL), validated and cross-culturally translated, which has been extensively utilised in rheumatology. In randomised controlled trials and observational studies, SF-36 provides rich data regarding HRQOL; but as typically portrayed, patterns of disease and treatment-associated effects can be difficult to discern. "Spydergrams" offer a simplified means to visualise complex results across all domains of SF-36 in a single figure: depicting disease and population-specific patterns of decrements in HRQOL compared with age and gender-matched normative data, as well as providing a tool for interpreting complex treatment-associated or longitudinal changes. Utilising spydergrams as a standard format to illustrate and report changes in SF-36 across different rheumatic diseases can greatly facilitate analyses and interpretations of clinical trial results, as well as providing patients an accessible means to compare baseline scores and treatment-associated improvements with normative data from individuals without arthritis. Furthermore, SF-6D utility scores based on mean changes across all eight domains of SF-36 are suggested as a quantitative means of summarising changes SPYDERGRAMSDifferences in the way individuals perceive and report HRQOL can be better interpreted by viewing baseline and change scores across domains, scored from 0 to 100, without ztransformation and normalisation as recommended in version 2 of SF-36, both of which reduce the magnitude of possible change. In contrast to the current practice of displaying SF-36 as eight-columned bar charts, "spydergrams" offer the ability to view changes more easily across all domains as a pattern recognition profile, depicting disease and population-specific "patterns" of decrements in baseline values compared with matched normative data, as well as treatment-associated or longitudinal changes. These "irregularly formed octagons or polygons" can be informative, reflecting different patterns of HRQOL and the impact of underlying disease on "multidimensional function".For heuristic or analytic purposes, SF-36 domain score bar graphs are presented as line graphs to aid the viewer in perceiving effects or trends. Similarly, in spydergrams categorical changes are connected (linked) to facilitate visual recognition of patterns, with the disclaimer that this is not intended to imply these are continuous scales. It is not unusual to see figures presented as line graphs that colour in the area below the line, not for significance as an "area under the curve" analysis, but to facilitate visual recognition of differences further. Spydergrams are an evolution from these standard practices, whereby the axis is simply rotated to connect with itself; bar graphs of baseline and changes in domain scores are connected with lines, and areas below the lines are shaded to facilitate pattern recognition.To compare across disease states, the order of domains presented should be con...

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326 Effectiveness and Safety of a Single Intraarticular Injection of Gel-200, a New Cross-Linked Formulation of Hyaluronic Acid [Ha] in the Treatment of Symptomatic Osteoarthritis [Oa] of the Knee

Cited by 5 publications

References 0 publications

Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews

Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews

Therapeutic trajectory following intra-articular hyaluronic acid injection in knee osteoarthritis – meta-analysis

Use of “spydergrams” to present and interpret SF-36 health-related quality of life data across rheumatic diseases

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