Comparative Efficacy of Novel DMARDs as Monotherapy and in Combination with Methotrexate in Rheumatoid Arthritis Patients with Inadequate Response to Conventional DMARDs: A Network Meta-Analysis

Buckley, F. Peter; Finckh, Axel; Huizinga, Tom W J; Dejonckheere, F.; Jansen, Jeroen P.

doi:10.18553/jmcp.2015.21.5.409

Cited by 75 publications

(57 citation statements)

References 60 publications

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“…In these analyses, most novel antirheumatic drugs, with the exception of anakinra, showed comparable clinical responses in combination with methotrexate [43, 44]. Indirect comparisons, however, have several limitations, and power and precision is dependent on the effective number of trials, sample size and heterogeneity of study populations.…”

Section: Discussionmentioning

confidence: 99%

Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Glinatsi

Heiberg

Rudin

et al. 2017

Trials

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BackgroundNew targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis (RA). However, it is unknown whether different early aggressive interventions can induce stable remission or a low-active disease state that can be maintained with conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy, and whether they differ in efficacy and safety. The Nordic Rheumatic Diseases Strategy Trials And Registries (NORD-STAR) study will assess and compare (1) the proportion of patients who achieve remission in a head-to-head comparison between csDMARD plus glucocorticoid therapy and three different biological DMARD (bDMARD) therapies with different modes of action and (2) two de-escalation strategies in patients who respond to first-line therapy.Methods/designIn a pragmatic, 80–160-week, multicenter, randomized, open-label, assessor-blinded, phase 4 study, 800 patients with early RA (symptom duration less than 24 months) are randomized 1:1:1:1 to one of four different treatment arms: (1) aggressive csDMARD therapy with methotrexate + sulphasalazine + hydroxychloroquine + i.a. glucocorticoids (arm 1A) or methotrexate + prednisolone p.o. (arm 1B), (2) methotrexate + certolizumab-pegol, (3) methotrexate + abatacept, or (4) methotrexate + tocilizumab. The primary clinical endpoint is the proportion of patients reaching Clinical Disease Activity Index (CDAI) remission at week 24. Patients in stable remission over 24 consecutive weeks enter part 2 of the study earliest after 48 weeks. Patients not achieving sustained CDAI remission over 24 consecutive weeks, exit the study after 80 weeks. In part 2, patients are re-randomized to two different de-escalation strategies, either immediate or delayed (after 24 weeks) tapering, followed by cessation of study medication. All patients remain on stable doses of methotrexate. The primary clinical endpoint in part 2 is the proportion of patients in remission (CDAI ≤2.8) 24 weeks after initiating treatment de-escalation. Radiographic assessment will be performed regularly throughout the trial, and blood and urine samples will be stored in a biobank for later biomarker analyses.DiscussionNORD-STAR is the first investigator-initiated, randomized, early RA trial to compare (1) csDMARD and three different bDMARD therapies head to head and (2) two different de-escalation strategies. The trial has the potential to identify which treatment strategy to apply in early RA to achieve the best possible outcomes for both patients and society.Trial registration NCT01491815 and NCT02466581. Registered on 8 December 2011 and May 2015, respectively.EudraCT: 2011-004720-35Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1891-x) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Glinatsi

Heiberg

Rudin

et al. 2017

Trials

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“…There are studies carried out in closed populations in Canadian centers where in spite of medical prescription, 58% of patients would not retrieve their medication from the pharmacy [30]. [31]. The Bayesian analysis based on 10 clinical studies carried out by Migliore et al, showed that tocilizumab had a 100% probability to be the best treatment as monotherapy in order to achieve ACR 20, in comparison to MTX, adalimumab and etanercept; similarly, a 99.8% and 98.7% probability to achieve ACR 50 and 70 respectively [32].…”

Section: Discussionmentioning

confidence: 99%

Frequency and Factors Associated with Biologic Monotherapy in Patients with Rheumatoid Arthritis; Experience from an Argentine Center

García-Salinas¹

2016

MOJOR

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“…[14]. Эти авторы провели сетевой мета-анализ 28 исследований, в которых оценивалась эффек-тивность ТЦЗ, ингибиторов фактора некроза опухоли α и ТОФА в режиме монотерапии и комбинированной тера-пии у пациентов с РА, не отвечающих на стандартные БПВП.…”

Section: о ц е н к а у р о в н я р и с к а с о в с р а в н и в а е м unclassified

Comparison of several alternative uses of targeted antirheumatic drugs in monotherapy for early rheumatoid arthritis

Шаталова¹,

Gorbatenko²

2017

RJTAO

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Цель исследования -оценить сравнительную эффективность тоцилизумаба (ТЦЗ) и тофацитиниба (ТОФА) у пациентов с тя-желым и среднетяжелым ревматоидным артритом (РА), которые ранее не получали метотрексат (МТ). Материал и методы. Выполнен систематический поиск исследований, посвященных оценке эффективности тоцилизумаба (ТЦЗ) и тофацитиниба (ТОФА), Тем не менее прослеживается тенденция к большей эффективности ТОФА (5 мг 2 раза в сутки) по сравнению с ТЦЗ (8 мг/кг). При непрямом сравнении ТОФА (10 мг 2 раза в сутки) и ТЦЗ (8 мг/кг) установле-но, что терапия ТЦЗ ассоциирована с более низкой частотой ответа по критериям ACR50 (на 37%): относительный риск (ОР) -0,63; 95% доверительный интервал (ДИ) -0,44-0,90 и ACR70 (на 51%): ОР -0,49; 95% ДИ -0,29-0,83

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Comparative Efficacy of Novel DMARDs as Monotherapy and in Combination with Methotrexate in Rheumatoid Arthritis Patients with Inadequate Response to Conventional DMARDs: A Network Meta-Analysis

Cited by 75 publications

References 60 publications

Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Frequency and Factors Associated with Biologic Monotherapy in Patients with Rheumatoid Arthritis; Experience from an Argentine Center

Comparison of several alternative uses of targeted antirheumatic drugs in monotherapy for early rheumatoid arthritis

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