Efficacy of tanezumab vs. placebo on pain, function, safety for patients with knee OA .
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(24):20 PLoS One. 2016 Jun 13;11(6):e0157105.4 randomized controlled trials (n=1833 patients) were included in this meta-analysis for the purpose of comparing analgesic efficacy and safety of tanezumab when compared to placebo treatment. Outcomes of interest included changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, WOMAC physical function, patient global assessment, the incidence of adverse events, and treatment discontinuation due to adverse effects. Results demonstrated that patients who were given tanezumab had significantly improved pain, function, and global assessment scores when compared to the placebo group. However, significant increases in therapy discontinuation due to adverse effects, development of abnormal peripheral sensation, and peripheral neuropathy were also observed.
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Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
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Sí = 1
Incierto = 0,5
No relevante = 0
No = 0
La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.
¿Por qué se necesitaba ahora este estudio?
First-line treatment for pain associated with osteoarthritis of the knee often includes paracetamol, non-steroidal anti-inflammatory drugs, and other select analgesic medication. Although the efficacy of these treatments has been established through research for the majority of patients with knee OA, there still remains the potential risk of hepatotoxicity, gastrointestinal distress, and cardiorenal side effects. Tanezumab, a newly developed monoclonal antibody, has shown a promising effect in selectively inhibiting nerve growth factor (NGF), a critical element in the experience of osteoarthritic pain. A recent study has shown promising therapeutic efficacy when compared to placebo, however, its use in patients with knee OA specifically has been sparse and inconclusive.
¿Cuál era la pregunta principal de la investigación?
What is the efficacy and safety of the use of Tanezumab for pain associated with osteoarthritis of the knee in terms of improvement in pain, function, patient global assessment, and incidence of adverse events?
- When compared to placebo, tanezumab groups demonstrated a significantly greater reduction in WOMAC pain scores (4 studies, n=1833 patients; SMD= 0.51 [95% CI 0.34-0.69], p<0.00001, I^2= 48%). (GRADE level of evidence: moderate)
- Tanezumab groups demonstrated a significantly greater reduction in WOMAC physical function scores when compared to placebo (4 studies, n=1833 patients; SMD=0.56 [95% CI 0.38-0.74], p<0.00001, I^2=52%). (GRADE level of evidence: low)
- Tanezumab groups demonstrated significantly greater improvement in PGA scores when compared to placebo (2 studies; SMD= 0.34 [95% CI 0.22-0.47], p<0.00001, I^2=0%). (GRADE level of evidence: moderate)
- When compared to placebo, tanezumab demonstrated a significantly higher risk of therapy discontinuation due to adverse events (3 studies; RR=2.89 [95% CI 1.59-5.26], p=0.0005, I^2=0%). (GRADE level of evidence: very low)
- Differences in incidence of serious adverse events (defined by requiring significant hospital intervention or causing disability, congenital anomaly, or death) were not significant between tanezumab and placebo groups (4 studies; RR=1.06 [95% CI 0.59-1.92], p=0.84, I^2=0%). (GRADE level of evidence: low)
- Tanezumab groups demonstrated a significant increase in the incidence of abnormal peripheral sensations when compared placebo (4 studies; RR=3.14 [95% CI 2.12-4.66], p<0.00001, I^2=16%). (GRADE level of evidence: low)
- Tanezumab groups demonstrated a significant increase in the incidence of peripheral neuropathy when compared the placebo group (2 studies; RR=6.05 [95% CI 2.32-15.81], p=0.0002, I^2=0%). (GRADE level of evidence: low)
- Subgroup analysis revealed that primary outcomes measures were not significantly different between tanezumab and placebo groups when tested for administration frequency (twice or thrice daily) or phase of the trial (phase II vs. phase III).
¿Qué es lo que más debo recordar?
For patients with osteoarthritis of the knee, treatment with tanezumab resulted in significant improvements in WOMAC pain, WOMAC function, and patient global assessment while maintaining comparable incidence of serious adverse events when compared to placebo therapy. However, tanezumab was associated with a significantly increased risk of therapy discontinuation due to adverse events, particularly due abnormal peripheral sensation and peripheral neuropathy.
¿Cómo afectará esto al cuidado de mis pacientes?
The results of this meta-analysis suggest that tanezumab may be of clinical benefit for patients with knee osteoarthritis as evidenced by significant improvements in pain, function, and assessment when compared to placebo. Significantly higher risks of therapy discontinuation (due to adverse effects), development of abnormal peripheral sensation and neuropathy were also noted. Further investigation with controlled methodology is recommended for validation of significant benefits. Direct comparisons made between tanezumab therapy and other popular modes of analgesic relief is also recommended to additionally compare the clinical and safety outcomes.
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