Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies

Charles‐Schoeman, Christina; Heijde, Desirée van der; Burmester, Gerd R; Nash, Peter; Zerbini, Cristiano A. F.; Connell, Carol A.; Fan, Huiying; Kwok, Kenneth; Bananis, Eustratios; Fleischmann, R.

doi:10.3899/jrheum.170486

Cited by 20 publications

(14 citation statements)

References 37 publications

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“…The ORAL START [ 80 – 88 ] study in MTX-naïve patients compared TOFA monotherapy (5 and 10 mg bid) with MTX monotherapy (10–20 mg/week). The number of patients achieving ACR20/50/70 (all P < 0.0001) and DAS28(ESR) remission (5 mg, P < 0.05; 10 mg, P < 0.001) at 6 months was shown to be significantly greater with 5 mg and 10 mg TOFA than with MTX [ 82 ].…”

Section: Resultsmentioning

confidence: 99%

“…For csDMARD-naïve patients with RA, there was no evidence to support the use of CZP or SRL as monotherapy. For ABA [ 18 – 22 ], BARI [ 34 , 35 ], ETN [ 49 ], SRK [ 33 ], and TOFA [ 80 – 88 ], the efficacy of each treatment as monotherapy was supported by only a single study. For ABA, BARI, ETN, and TOFA, monotherapy was more efficacious than MTX.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review

Emery

Pope

Krüger³

et al. 2018

Adv Ther

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Despite recommendations suggesting that biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) should be used in combination with methotrexate in the treatment of rheumatoid arthritis (RA), up to one-third of patients with RA are treated with monotherapy. The objective of the systematic literature review reported here was to evaluate the clinical evidence regarding the efficacy of b/tsDMARDs as monotherapy in the treatment of RA. MEDLINE®, Embase®, and the Cochrane Central Trials Register (to April 11, 2017) and the American College of Rheumatology and European League Against Rheumatism conference proceedings (2010–2016) were searched for randomized controlled trials evaluating the efficacy of b/tsDMARDs as monotherapy for RA in adults. Forty-four monotherapy studies of abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, sarilumab, sirukumab, tocilizumab, and tofacitinib reported in 71 publications were identified. Tocilizumab had the most studies (14), followed by etanercept (10) and adalimumab (9). These b/tsDMARDs were consistently shown to be efficacious treatments, regardless of whether patients were intolerant of or had never used conventional synthetic (cs) DMARDs. However, better treatment outcomes were usually achieved with combination therapy, and this was observed for all b/tsDMARDs assessed by this review. Only a few studies provided a head-to-head comparison between b/tsDMARD treatments or between b/tsDMARD monotherapy and combination therapy, and as many were initial RA treatments they were not generalizable to usual care. In conclusion, evidence from randomized trials suggests that the b/tsDMARDs studied are effective as monotherapy. In general, some patient responses seem better with combination therapy and the durability of monotherapy is less than combination therapy. There is, however, a need for longer-term head-to-head trials to establish positioning of these interventions in the treatment algorithm for RA.Funding: Pfizer.Plain Language Summary: Plain language summary available on the journal website.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0757-2) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review

Emery

Pope

Krüger³

et al. 2018

Adv Ther

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“…In an open-label study,9 efficacy benefits of TCZ were similar between RA patients with and without previous and continued oral GC treatment, with generally similar safety profiles, corroborating our results. In six tofacitinib trials, background GC use did not affect clinical or radiographic efficacy 16…”

Section: Discussionmentioning

confidence: 96%

Effect on efficacy and safety trial outcomes of also enrolling patients on ongoing glucocorticoid therapy in rheumatoid arthritis clinical trials of tocilizumab or adalimumab or methotrexate monotherapy

Safy-Khan

Jacobs

Hair

et al. 2020

Annals of the Rheumatic Diseases

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BackgroundIn rheumatoid arthritis (RA) trials, inclusion of patients on background treatment with glucocorticoids (GCs) might impact efficacy and safety outcomes.ObjectivesTo determine if inclusion of patients on background GC use influenced efficacy and safety outcomes of RA randomised clinical trials on initiation of tocilizumab (TCZ) or adalimumab (ADA) or methotrexate (MTX) monotherapy.MethodsData of four double-blind RA randomised controlled trials (AMBITION, ACT-RAY, ADACTA and FUNCTION) with in total four TCZ, one ADA and two MTX monotherapy arms were analysed. Analyses of covariance of changes from baseline to week 24 in efficacy endpoints and radiographic progression up to week 104 were performed, correcting for relevant covariates. Incidence rates of serious adverse events (SAEs) were assessed.ResultsNo statistically significant differences were found in efficacy parameters between background GC users and non-GC users, except for less radiographic progression associated with GC usage in one MTX arm. SAE rates were not statistically significantly different between GC users and non-GC users in the treatment arms.ConclusionNo effect of including patients on background GC treatment on efficacy and safety trial outcomes was found, with the exception of reduced radiological joint damage in one MTX arm.

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“…A posthoc analysis of six phase III studies evaluating tofacitinib in RA, in monotherapy (ORAL start, ORAL Solo) or combined with csDMARDs (ORAL Scan, ORAL Standard, ORAL Sync, ORAL Step), examined the impact of the presence of GCs in the treatment groups 41. Mean dose of GCs was approximately of 6 mg/day.…”

Section: Glucocorticoids Use Strategiesmentioning

confidence: 99%

Glucocorticoids in rheumatoid arthritis: current status and future studies

2020

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Since their first use for treating rheumatoid arthritis (RA) in the late 1940s, glucocorticoids (GCs) have been representing a substantial part of the therapeutic arsenal for RA. However, even if GCs are still widely prescribed drugs, their toxicity is discussed controversially, so obtaining consensus on their use in RA is difficult. Hence, the most recent European League Against Rheumatism and American College of Rheumatology recommendations on early arthritis and RA management advocate the use of GCs as adjunct treatment to conventional synthetic disease-modifying antirheumatic drugs, at the lowest dose possible and for the shortest time possible. However, the recommendations remain relatively vague on dose regimens and routes of administration. Here, we describe literature data on which the current recommendations are based as well as data from recent trials published since the drafting of the guidelines. Moreover, we make proposals for daily practice and provide suggestions for studies that could help clarifying the place of GCs in RA management. Indeed, numerous items, including the benefit/risk ratio of low-dose and very low-dose GCs and optimal duration of GCs as bridging therapy, remain on the research agenda, and future studies are needed to guide the next recommendations for RA.

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Effect of Glucocorticoids on the Clinical and Radiographic Efficacy of Tofacitinib in Patients with Rheumatoid Arthritis: A Posthoc Analysis of Data from 6 Phase III Studies

Abstract: Concomitant use of GC with tofacitinib did not appear to affect clinical or radiographic efficacy. MTX plus GC showed a trend to inhibit radiographic progression to a greater degree than MTX alone.

Cited by 20 publications

References 37 publications

Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review

Efficacy of Monotherapy with Biologics and JAK Inhibitors for the Treatment of Rheumatoid Arthritis: A Systematic Review

Effect on efficacy and safety trial outcomes of also enrolling patients on ongoing glucocorticoid therapy in rheumatoid arthritis clinical trials of tocilizumab or adalimumab or methotrexate monotherapy

Glucocorticoids in rheumatoid arthritis: current status and future studies

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