Mixed treatment comparison of efficacy and tolerability of biologic agents in patients with rheumatoid arthritis

Hochberg, Marc C.; Berry, Scott M.; Broglio, Kristine; Rosenblatt, Lisa; Nadkarni, Anagha; Trivedi, Digisha; Hebden, Tony

doi:10.1185/03007995.2013.813839

Cited by 9 publications

(11 citation statements)

References 40 publications

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“…Some studies that carried out indirect comparison of the efficacy of different biologicals in RA found that the difference between infliximab and other biologicals were not statistically significant [4, 58–61], which supports our results for infliximab and infliximab-biosimilar.…”

Section: Discussionsupporting

confidence: 89%

“…Regarding safety and tolerability, some of the studies found significant differences between treatments, e.g., in favor of etanercept [58] or in favor of abatacept compared to a combined group of biologicals [61]. However, these studies examined a tolerability endpoint, namely the withdrawal of therapy due to adverse events, while we examined safety in terms of the occurrence of serious adverse events.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison

et al. 2014

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ObjectiveThe aim of this meta-analysis was to compare the efficacy and safety of infliximab-biosimilar and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab.MethodsA systematic literature review of MEDLINE database until August 2013 was carried out to identify relevant randomized controlled trials (RCTs). Bayesian mixed treatment comparison method was applied for the pairwise comparison of treatments. Improvement rates by the American College of Rheumatology criteria (ACR20 and ACR50) at week 24 were used as efficacy endpoints, and the occurrence of serious adverse events was considered to assess the safety of the biologicals.ResultsThirty-six RCTs were included in the meta-analysis. All the biological agents proved to be superior to placebo. For ACR20 response, certolizumab pegol showed the highest odds ratio (OR) compared to placebo, OR 7.69 [95 % CI 3.69–14.26], followed by abatacept OR 3.7 [95 % CI 2.17–6.06], tocilizumab OR 3.69 [95 % CI 1.87–6.62] and infliximab-biosimilar OR 3.47 [95 % CI 0.85–9.7]. For ACR50 response, certolizumab pegol showed the highest OR compared to placebo OR 8.46 [3.74–16.82], followed by tocilizumab OR 5.57 [95 % CI 2.77–10.09], and infliximab-biosimilar OR 4.06 [95 % CI 1.01–11.54]. Regarding the occurrence of serious adverse events, the results show no statistically significant difference between infliximab-biosimilar and placebo, OR 1.87 [95 % CI 0.74–3.84]. No significant difference regarding efficacy and safety was found between infliximab-biosimilar and the other biological treatments.ConclusionThis is the first indirect meta-analysis in RA that compares the efficacy and safety of biosimilar-infliximab to the other biologicals indicated in RA. We found no significant difference between infliximab-biosimilar and other biological agents in terms of clinical efficacy and safety.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison

et al. 2014

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“…Desai et al (10) (11) reported estimates favoring adalimumab for treatment discontinuations due to AEs (OR 2.00, 95% CrI 1.17-3.49), which is also consistent with our conclusion. Hochberg et al (9) combined etanercept, infliximab, and adalimumab as a single TNF inhibitor group and compared the treatment discontinuations due to AEs with abatacept. Therefore, their estimates are not directly comparable with observations from the current study.…”

Section: Discussionmentioning

confidence: 99%

“…Three prior systematic reviews conducted indirect comparisons using Bayesian methods for evaluating the comparative safety of TIMs using RCT data (9)(10)(11). The safety outcome evaluated in all 3 reviews was discontinuations due to AEs reported in RCTs of individual TIMs.…”

Section: Discussionmentioning

confidence: 99%

“…Since studies comparing TIMs head-to-head are uncommon, evidence regarding the comparative risk of serious adverse events (AEs) among users of individual TIMs is less conclusive. In the absence of direct evidence, published studies derive comparative estimates for the risk of AEs, as approximated by treatment discontinuations, from indirect comparison approaches using data from a systematic review of RCTs (9)(10)(11). Although indirect comparison approaches contribute vital data to the literature and generate hypotheses informing future research, they have methodological limitations and do not possess the validity of head-to-head comparisons.…”

Section: Introductionmentioning

confidence: 99%

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Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review

Desai

Thaler

Mahlknecht

et al. 2016

Arthritis Care & Research

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ObjectiveTo systematically compare the risk of adverse events (AEs) for 13 targeted immunomodulators (TIMs) indicated for ankylosing spondylitis (AS), inflammatory bowel diseases, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis (PsA), or rheumatoid arthritis (RA).MethodsWe searched electronic databases through July 2015 to retrieve randomized controlled trials (RCTs) and observational studies comparing AEs between 2 or more TIMs head‐to‐head. We reported on the following outcomes: number of AEs, discontinuation due to AEs, serious AEs, mortality, serious infections, tuberculosis, herpes zoster, and malignancies. We qualitatively synthesized the literature and conducted random‐effects meta‐analyses if 3 or more studies provided data for an outcome.ResultsTen head‐to‐head RCTs and 51 observational studies were included in this systematic review. A majority of the studies (70%) were conducted in RA patients. Risk of treatment discontinuation due to AEs was higher with infliximab than with adalimumab or etanercept in RA, PsA, and AS. A higher risk for serious infections was noted with infliximab than with abatacept, adalimumab, or etanercept in RA. Risk for treatment discontinuation due to AEs, serious infections, and tuberculosis was lower with etanercept than with adalimumab in RA. Limited evidence suggested no comparative differences in risk for mortality, malignancies, and herpes zoster for adalimumab, etanercept, and infliximab in RA.ConclusionImportant differences were noted in the safety profile of TIMs in RA, generally favoring abatacept, adalimumab, and etanercept over infliximab. Head‐to‐head comparative evidence for other TIMs and non‐RA populations was insufficient to draw conclusions for most of the safety outcomes.

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Comparative Analyses of Pharmaceuticals or Food Supplements Containing Chondroitin Sulfate: Are Their Bioactivities Equivalent?

et al. 2019

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IntroductionOral supplementation of chondroitin sulfate (CS) and glucosamine (GlcN), symptomatic slow-acting molecules, is recommended by European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis and Musculoskeletal Diseases (ESCEO) and other European Union (EU) guidelines for the restoration of the articular cartilage surface in patients affected by osteoarthritis (OA). They are commercialized as pharmaceutical grade products and as food supplements in combination with plant extracts hyaluronic acid, methylsulfonylmethane, and other components. Food supplements do not need to undergo the strict regulatory controls of pharmaceutical grade products; thus, composition and contaminants that could be present may not be evidenced before commercialization and these uncertainties may give rise to concerns about the bioactivity of these formulations.MethodsIn this paper 10 different food supplements (FS) from diverse European countries were analyzed in comparison with two pharmaceutical grade products (Ph) using updated analytical approaches and biochemical cell-based assays. The purity, the titer, and the origin of CS in Ph and FS samples were initially assessed in order to successively compare the biological function. Both food supplements and pharmaceutical formulations were tested in vitro, using the same final CS concentration, on primary chondrocytes and synoviocytes in terms of (i) cell viability, (ii) activation of the NF-κB-mediated inflammation pathway, (iii) cartilage oligomeric matrix protein (COMP-2), IL-6, and IL-8 production.ResultsAll the FS presented a certain insoluble fraction; the CS and the GlcN contents were lower than the declared ones in 9/10 and 8/10 samples, respectively. All FS contained keratan sulfate (KS) at up to 50% of the total glycosaminoglycan amount declared on the label. Primary cells treated with the samples diluted to present the same CS concentration in the medium showed cytotoxicity in 7/10 FS while Ph preserved viability and reduced NF-κB, COMP-2, and secreted inflammatory cytokines.ConclusionAmong all samples tested, the pharmaceutical grade products demonstrated effective modulation of biomarkers counteracting the inflammation status and improving viability and the physiological condition of OA human primary chondrocyte and synoviocyte cells. In contrast to that, most FS were cytotoxic at the tested concentrations, and only 3/10 of them showed similarities to Ph sample behavior in vitro.FundingThis work was partially supported by PON01_1226 NUTRAFAST, MIUR Ministero dell’Università e della Ricerca Scientifica. Bioteknet financed two short-term grants for graduate technicians. The journal’s Rapid Service and Open Access fees were funded by IBSA CH.

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Mixed treatment comparison of efficacy and tolerability of biologic agents in patients with rheumatoid arthritis

Abstract: In this MTC, abatacept demonstrated similar efficacy at 6 months, a higher likelihood of achieving ACR70 response and DAS28 remission at 12 months and better tolerability relative to the combined TNFi in patients with RA who had an inadequate response to conventional DMARDs.

Cited by 9 publications

References 40 publications

Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison

Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison

Comparative Risk of Harm Associated With the Use of Targeted Immunomodulators: A Systematic Review

Comparative Analyses of Pharmaceuticals or Food Supplements Containing Chondroitin Sulfate: Are Their Bioactivities Equivalent?

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