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Efficacy, safety and tolerability of tofacitinib in patients with an inadequate response to disease modifying anti-rheumatic drugs: a meta-analysis of randomized double-blind controlled studies.

Berhan A - BMC Musculoskelet Disord (2013)

Bottom Line: The odds of tofacitinib treated patients who met the criteria for an at least a 20% improvement in the American College of Rheumatology scale (ACR 20) was more than 4 times higher than placebo treated patients (overall OR = 4.15; 95% CI, 3.23 to 5.32).Even though the discontinuation rate due to adverse events was not different from placebo groups, tofacitinib was associated with infections (overall SMD = 1.96, 95% CI = 1.428 to 2.676), reduction in neutrophil counts (overall SMD = -0.34, 95% CI = -0.450 to -0.223) and elevated levels of LDL cholesterol and liver enzymes.However, treatment with tofacitinib was associated with infections and laboratory abnormalities.

View Article: PubMed Central - HTML - PubMed

Affiliation: Hawassa University College of Medicine and Health Sciences, P, O, Box: 1560, Hawassa, Ethiopia. asresb@hu.edu.et.

ABSTRACT

Background: This meta-analysis was conducted to determine the efficacy, safety and tolerability of tofacitinib in the treatment of rheumatoid arthritis in patients with an inadequate response or intolerance to at least one of the nonbiologic or biologic disease-modifying antirheumatic drugs (DMARDs).

Methods: Electronic based literature search was conducted in the databases of HINARI (Health InterNetwork Access to Research Initiative), MEDLINE and Cochrane library. The studies included in the meta-analysis were double-blind randomized clinical trials that were conducted in treatment-refractory or intolerant patients with rheumatoid arthritis. The odds ratios (OR), standardized mean differences (SMD) and the 95% confidence intervals (95% CI) were determined by using the random effects model. Heterogeneity among the included studies was evaluated by I² statistics.

Results: The odds of tofacitinib treated patients who met the criteria for an at least a 20% improvement in the American College of Rheumatology scale (ACR 20) was more than 4 times higher than placebo treated patients (overall OR = 4.15; 95% CI, 3.23 to 5.32). Even though the discontinuation rate due to adverse events was not different from placebo groups, tofacitinib was associated with infections (overall SMD = 1.96, 95% CI = 1.428 to 2.676), reduction in neutrophil counts (overall SMD = -0.34, 95% CI = -0.450 to -0.223) and elevated levels of LDL cholesterol and liver enzymes.

Conclusions: Tofacitinib was effective in the treatment of active rheumatoid arthritis in patients with an inadequate response or intolerance to at least one DMARDs. However, treatment with tofacitinib was associated with infections and laboratory abnormalities.

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Standardize mean difference of change in neutrophils count from baseline (1000/mm3).
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Figure 5: Standardize mean difference of change in neutrophils count from baseline (1000/mm3).

Mentions: Whilst, with a significant heterogeneity (I2 = 52%), tofacitinib treatment was significantly associated with reduction in neutrophil counts (overall SMD = -0.34, 95% CI = -0.450 to -0.223) (Figure 5). The subgroups SMDs were not significant in the subgroups of tofacitinib 3-mg and 15-mg; but the numbers of studies in the subgroups were very small (only 2 studies in both subgroups).


Efficacy, safety and tolerability of tofacitinib in patients with an inadequate response to disease modifying anti-rheumatic drugs: a meta-analysis of randomized double-blind controlled studies.

Berhan A - BMC Musculoskelet Disord (2013)

Standardize mean difference of change in neutrophils count from baseline (1000/mm3).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4222887&req=5

Figure 5: Standardize mean difference of change in neutrophils count from baseline (1000/mm3).
Mentions: Whilst, with a significant heterogeneity (I2 = 52%), tofacitinib treatment was significantly associated with reduction in neutrophil counts (overall SMD = -0.34, 95% CI = -0.450 to -0.223) (Figure 5). The subgroups SMDs were not significant in the subgroups of tofacitinib 3-mg and 15-mg; but the numbers of studies in the subgroups were very small (only 2 studies in both subgroups).

Bottom Line: The odds of tofacitinib treated patients who met the criteria for an at least a 20% improvement in the American College of Rheumatology scale (ACR 20) was more than 4 times higher than placebo treated patients (overall OR = 4.15; 95% CI, 3.23 to 5.32).Even though the discontinuation rate due to adverse events was not different from placebo groups, tofacitinib was associated with infections (overall SMD = 1.96, 95% CI = 1.428 to 2.676), reduction in neutrophil counts (overall SMD = -0.34, 95% CI = -0.450 to -0.223) and elevated levels of LDL cholesterol and liver enzymes.However, treatment with tofacitinib was associated with infections and laboratory abnormalities.

View Article: PubMed Central - HTML - PubMed

Affiliation: Hawassa University College of Medicine and Health Sciences, P, O, Box: 1560, Hawassa, Ethiopia. asresb@hu.edu.et.

ABSTRACT

Background: This meta-analysis was conducted to determine the efficacy, safety and tolerability of tofacitinib in the treatment of rheumatoid arthritis in patients with an inadequate response or intolerance to at least one of the nonbiologic or biologic disease-modifying antirheumatic drugs (DMARDs).

Methods: Electronic based literature search was conducted in the databases of HINARI (Health InterNetwork Access to Research Initiative), MEDLINE and Cochrane library. The studies included in the meta-analysis were double-blind randomized clinical trials that were conducted in treatment-refractory or intolerant patients with rheumatoid arthritis. The odds ratios (OR), standardized mean differences (SMD) and the 95% confidence intervals (95% CI) were determined by using the random effects model. Heterogeneity among the included studies was evaluated by I² statistics.

Results: The odds of tofacitinib treated patients who met the criteria for an at least a 20% improvement in the American College of Rheumatology scale (ACR 20) was more than 4 times higher than placebo treated patients (overall OR = 4.15; 95% CI, 3.23 to 5.32). Even though the discontinuation rate due to adverse events was not different from placebo groups, tofacitinib was associated with infections (overall SMD = 1.96, 95% CI = 1.428 to 2.676), reduction in neutrophil counts (overall SMD = -0.34, 95% CI = -0.450 to -0.223) and elevated levels of LDL cholesterol and liver enzymes.

Conclusions: Tofacitinib was effective in the treatment of active rheumatoid arthritis in patients with an inadequate response or intolerance to at least one DMARDs. However, treatment with tofacitinib was associated with infections and laboratory abnormalities.

Show MeSH
Related in: MedlinePlus