Comparison of tocilizumab and tumour necrosis factor inhibitors in rheumatoid arthritis: a retrospective analysis of 1603 patients managed in routine clinical practice

Clinical Rheumatology, Jan 2015

Tocilizumab (TCZ) and tumour necrosis factor inhibitors (TNFi) are recommended for the treatment of rheumatoid arthritis (RA) in patients with inadequate response (IR) to prior disease-modifying antirheumatic drugs (DMARDs). This retrospective analysis assessed the efficacy of TCZ and TNFi, alone or in combination with DMARDs, in 1603 patients with IR to previous treatment with either DMARDs (DMARD-IR) and/or TNFi (TNFi-IR), initiating treatment with TCZ or a TNFi, managed in routine clinical practice. Patients were grouped according to treatment history and treatment initiated: DMARD-IR patients initiating treatment with TCZ + DMARD (DMARD-IR TCZ) or TNFi + DMARD (DMARD-IR TNFi), DMARD-IR and/or TNFi-IR patients initiating treatment with TCZ monotherapy (TCZ mono) or TNFi monotherapy (TNFi mono), and TNFi-IR patients initiating treatment with TCZ + DMARD (TNFi-IR TCZ) or TNFi + DMARD (TNFi-IR TNFi). Patients initiating treatment with TCZ generally had more severe disease and longer disease duration compared with the corresponding TNFi group. Significantly more patients achieved remission (DAS28 ESR <2.6) in the TCZ groups compared with corresponding TNFi groups (DMARD-IR, TCZ 44.0 % vs. TNFi 29.6 %; monotherapy, TCZ 37.2 % vs. TNFi 30.2 %; TNF-IR, TCZ 41.3 % vs. TNFi 19.2 %; p < 0.001 for all comparisons). More patients achieved moderate–good responses (EULAR criteria) in the TCZ treatment groups (79–85 %) compared with TNFi treatment groups (65–81 %). Patient-reported outcomes showed greater improvements in TCZ compared with TNFi groups. In patients with inadequate response to DMARDs and/or TNFi treated in routine clinical practice, TCZ in combination with DMARDs or as monotherapy resulted in significantly more patients achieving remission and more marked improvements in patient-reported outcomes compared with TNF inhibitors.

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Comparison of tocilizumab and tumour necrosis factor inhibitors in rheumatoid arthritis: a retrospective analysis of 1603 patients managed in routine clinical practice

Marina Backhaus 0 1 3 4 5 6 Jrg Kaufmann 0 1 3 4 5 6 Constanze Richter 0 1 3 4 5 6 Siegfried Wassenberg 0 1 3 4 5 6 Anne-Eve Roske 0 1 3 4 5 6 Peter Hellmann 0 1 3 4 5 6 Markus Gaubitz 0 1 3 4 5 6 0 C. Richter Internistisch-rheumatologische Schwerpunktpraxis , Stuttgart , Germany 1 J. Kaufmann Praxis Dr. med Jorg Kaufmann , Ludwigsfelde , Germany 2 ) Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie , Charite-Universitatsmedizin Berlin, Chariteplatz 1, 10117 Berlin , Germany 3 M. Gaubitz Akademie fur Manuelle Therapie an der WWU Munster, Interdisziplinare Diagnostik und Therapie , Munster , Germany 4 P. Hellmann Chugai Pharma , Frankfurt , Germany 5 A.<E. Roske Roche Pharma AG , Grenzach-Wyhlen , Germany 6 S. Wassenberg Fachkrankenhaus Ratingen - Rheumatologische Klinik, Rheumazentrum Ratingen , Ratingen , Germany Tocilizumab (TCZ) and tumour necrosis factor inhibitors (TNFi) are recommended for the treatment of rheumatoid arthritis (RA) in patients with inadequate response (IR) to prior disease-modifying antirheumatic drugs (DMARDs). This retrospective analysis assessed the efficacy of TCZ and TNFi, alone or in combination with DMARDs, in 1603 - patients with IR to previous treatment with either DMARDs (DMARD-IR) and/or TNFi (TNFi-IR), initiating treatment with TCZ or a TNFi, managed in routine clinical practice. Patients were grouped according to treatment history and treatment initiated: DMARD-IR patients initiating treatment with TCZ + DMARD (DMARD-IR TCZ) or TNFi + DMARD (DMARD-IR TNFi), DMARD-IR and/or TNFi-IR patients initiating treatment with TCZ monotherapy (TCZ mono) or TNFi monotherapy (TNFi mono), and TNFi-IR patients initiating treatment with TCZ + DMARD (TNFi-IR TCZ) or TNFi + DMARD (TNFi-IR TNFi). Patients initiating treatment with TCZ generally had more severe disease and longer disease duration compared with the corresponding TNFi group. Significantly more patients achieved remission (DAS28 ESR <2.6) in the TCZ groups compared with corresponding TNFi groups (DMARD-IR, TCZ 44.0 % vs. TNFi 29.6 %; monotherapy, TCZ 37.2 % vs. TNFi 30.2 %; TNF-IR, TCZ 41.3 % vs. TNFi 19.2 %; p<0.001 for all comparisons). More patients achieved moderategood responses (EULAR criteria) in the TCZ treatment groups (7985 %) compared with TNFi treatment groups (6581 %). Patient-reported outcomes showed greater improvements in TCZ compared with TNFi groups. In patients with inadequate response to DMARDs and/or TNFi treated in routine clinical practice, TCZ in combination with DMARDs or as monotherapy resulted in significantly more patients achieving remission and more marked improvements in patient-reported outcomes compared with TNF inhibitors. Rheumatoid arthritis (RA) is a common chronic inflammatory disease associated with progressive joint destruction, pain, fatigue and disability. Current treatments target the inflammatory response using disease-modifying antirheumatic drugs (DMARDs) and biological agents, in combination or as monotherapy. Five classes of biologics with differing modes of action are currently used in the treatment of RA: tumour necrosis factor inhibitors (TNFi) (adalimumab, certolizumab, etanercept, golimumab and infliximab), an interleukin (IL)-1 receptor antagonist (anakinra), a selective T-cell costimulatory modulator (abatacept), a chimeric anti-CD20 monoclonal antibody (rituximab) and a humanised antiIL-6 receptor antibody (tocilizumab (TCZ)). Treatment guidelines recommend DMARDs (initially methotrexate [MTX]) as immediate first-line therapy in patients with RA, followed by combination therapy with conventional DMARDs, or with biological agents in combination with DMARDs, should patients fail to achieve remission or low disease activity on DMARDs alone [1, 2]. Monotherapy with biologics is not generally recommended for all agents in current guidelines, although in German guidelines, TCZ is recommended as monotherapy particularly in patients with intolerance to MTX or when the continuation of MTX therapy is considered inappropriate for other reasons [3]. The majority of available data on biologics in RA have been from studies of TNFis, and although shown to be more effective in combination with MTX than MTX alone, TNFi monotherapy was also shown to be less effective than combination therapy [48]. In more recent studies, TCZ has been shown to be effective both in combination with DMARDs and also as monotherapy in patients who had previously had an inadequate response to DMARDs (DMARD-IR) [913] or to TNF inhibitors (TNFi-IR) [1416]. Most recently, the large Phase IV ADACTA trial demonstrated superior efficacy for monotherapy with TCZ as compared to monotherapy with the TNFi adalimumab in patients who were intolerant to, or unsuitable for, treatment with methotrexate [17]. However, such suitably powered randomised clinical head-to-head trials for biologics in RA are rare. Due to strict inclusion and exclusion criteria, a randomised trial might not reflect cl (...truncated)


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Marina Backhaus, Jörg Kaufmann, Constanze Richter, Siegfried Wassenberg, Anne-Eve Roske, Peter Hellmann, Markus Gaubitz. Comparison of tocilizumab and tumour necrosis factor inhibitors in rheumatoid arthritis: a retrospective analysis of 1603 patients managed in routine clinical practice, Clinical Rheumatology, 2015, pp. 673-681, Volume 34, Issue 4, DOI: 10.1007/s10067-015-2879-0