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Methotrexate safety...
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Lend, KristinaKarolinska Institutet
(author)
Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: a post-hoc analysis of a randomized controlled trial (NORD-STAR).
- Article/chapterEnglish2024
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LIBRIS-ID:oai:gup.ub.gu.se/331171
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https://gup.ub.gu.se/publication/331171URI
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https://doi.org/10.1002/art.42730DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:154689976URI
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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To investigate methotrexate safety and influence of dose on efficacy outcomes in combination with three different biological treatments and with active conventional treatment (ACT) in early rheumatoid arthritis (RA).This post-hoc analysis included 812 treatment-naïve early RA patients who were randomized (1:1:1:1) in the NORD-STAR trial (NCT01491815) to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab. Methotrexate safety, doses, and dose effects on Clinical Disease Activity Index (CDAI) remission were assessed after 24weeks of treatment.Compared with ACT, the prevalence of methotrexate-associated side effects was higher when methotrexate was combined with tocilizumab (HR 1.48 [95% CI 1.20 to 1.84]), but not with certolizumab-pegol (HR 0.99 [0.79 to 1.23]) or with abatacept (HR 0.93 [0.75 to 1.16]). With ACT as the reference, methotrexate dose was significantly lower when used in combination with tocilizumab (β -4.65 [95% CI -5.83 to -3.46], p<0.001), with abatacept (β -1.15 [-2.27 to -0.03], p=0.04), and numerically lower in combination with certolizumab-pegol (β -1.07 [-2.21 to 0.07], p=0.07). Methotrexate dose reductions were not associated with decreased CDAI remission rates within any of the treatment combinations.Methotrexate was generally well tolerated in combination therapies, but adverse events were a limiting factor in receiving the target dose of 25 mg/week, and these were more frequent in combination with tocilizumab versus active conventional treatment. On the other hand, methotrexate dose reductions were not associated with decreased CDAI remission rates within any of the four treatment combinations at 24weeks.
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Koopman, Frieda A
(author)
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Lampa, JonKarolinska Institutet
(author)
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Jansen, Gerrit
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Hetland, Merete L
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Uhlig, Till
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Nordström, Dan
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Nurmohamed, Michael
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Gudbjornsson, Bjorn
(author)
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Rudin, Anna,1961Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning,Institute of Medicine, Department of Rheumatology and Inflammation Research(Swepub:gu)xrudan
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Østergaard, Mikkel
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Heiberg, Marte S
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Sokka-Isler, Tuulikki
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Hørslev-Petersen, Kim
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Haavardsholm, Espen A
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Grondal, Gerdur
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Twisk, Jos W R
(author)
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van Vollenhoven, Ronald
(author)
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Karolinska InstitutetInstitutionen för medicin, avdelningen för reumatologi och inflammationsforskning
(creator_code:org_t)
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In:Arthritis & rheumatology (Hoboken, N.J.)76:3, s. 363-3762326-5205
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Lend, Kristina
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Koopman, Frieda ...
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Lampa, Jon
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Jansen, Gerrit
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Hetland, Merete ...
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Uhlig, Till
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Nordström, Dan
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Heiberg, Marte S
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Sokka-Isler, Tuu ...
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Hørslev-Petersen ...
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Haavardsholm, Es ...
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Grondal, Gerdur
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Twisk, Jos W R
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- MEDICAL AND HEALTH SCIENCES
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and Rheumatology and ...
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Arthritis & rheu ...
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University of Gothenburg
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Karolinska Institutet