Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: The AMBITION study
Graeme Jones,Anthony Sebba,Jieruo Gu,Mitchell B. Lowenstein,Armando Calvo,Juan J. Gomez-Reino,Daniel Siri,Matija Tomšič,Emma Alecock,Thasia G. Woodworth,Mark C. Genovese +10 more
Reads0
Chats0
TLDR
Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotRexate or biological agents has not previously failed.Abstract:
Background: The anti-interleukin (IL) 6 receptor antibody tocilizumab inhibits signalling of IL6, a key cytokine in rheumatoid arthritis (RA) pathogenesis. Objective: To evaluate through the AMBITION study the efficacy and safety of tocilizumab monotherapy versus methotrexate in patients with active RA for whom previous treatment with methotrexate/biological agents had not failed. Methods: This 24-week, double-blind, double-dummy, parallel-group study, randomised 673 patients to either tocilizumab 8 mg/kg every 4 weeks, or methotrexate, starting at 7.5 mg/week and titrated to 20 mg/week within 8 weeks, or placebo for 8 weeks followed by tocilizumab 8 mg/kg. The primary end point was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 24. Results: The intention-to-treat analysis demonstrated that tocilizumab was better than methotrexate treatment with a higher ACR20 response (69.9 vs 52.5%; p 3×– Conclusion: Tocilizumab monotherapy is better than methotrexate monotherapy, with rapid improvement in RA signs and symptoms, and a favourable benefit–risk, in patients for whom treatment with methotrexate or biological agents has not previously failed. Trial registration number: NCT00109408read more
Citations
More filters
Journal Article
Tocilizumab in severe and refractory non-infectious uveitis.
Matthias Papo,Philip Bielefeld,H. Vallet,Pascal Sève,B. Wechsler,Patrice Cacoub,Le Hoang P,Thomas Papo,Bahram Bodaghi,D. Saadoun +9 more
TL;DR: Tocilizumab seems to be a safe and promising therapy in severe and refractory non-infectious uveitis.
Journal ArticleDOI
Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis: 2-year clinical and radiographic results from the randomised, placebo-controlled FUNCTION trial
Gerd R Burmester,William F. C. Rigby,Ronald F van Vollenhoven,Jonathan Kay,Andrea Rubbert-Roth,Ricardo Blanco,AK Kadva,Sophie Dimonaco +7 more
TL;DR: Patients with early RA treated with TCZ monotherapy or TCZ+MTX maintained clinical benefits during their second year of treatment with no new safety signals, and the safety profile of TCZ was consistent with that of previous reports.
Journal ArticleDOI
Matrix Metalloproteinase Gene Activation Resulting from Disordred Epigenetic Mechanisms in Rheumatoid Arthritis
Yasuto Araki,Toshihide Mimura +1 more
TL;DR: The role of MMPs in the pathogenesis of RA as well as the disordered epigenetic mechanisms regulating MMP gene activation in RASFs are reviewed.
Journal ArticleDOI
Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease‐modifying anti‐rheumatic drugs: a systematic review and network meta‐analysis
Jasvinder A. Singh,Alomgir Hossain,Elizabeth Tanjong Ghogomu,Ahmed Kotb,Robin Christensen,Amy S. Mudano,Lara J Maxwell,Nipam Shah,Peter Tugwell,George A. Wells +9 more
TL;DR: Based on direct evidence of moderate quality (downgraded for inconsistency), biologic+MTX/DMARD was associated with a clinically and statistically important improvement in function measured by the Health Assessment Questionnaire and was associatedWith a statistically significant and clinically meaningful improvement in ACR50 versus comparator.
Journal ArticleDOI
Safety and Efficacy of Tocilizumab for the Treatment of Rheumatoid Arthritis
TL;DR: TCZ is one of the most prospective next generation biologics for the treatment of RA and has some advantage in RA patients who can not use MTX and are non-responders to TNF inhibitors.
References
More filters
Journal ArticleDOI
Modified disease activity scores that include twenty-eight-joint counts : development and validation in a prospective longitudinal study of patients with rheumatoid arthritis
M.L.L. Prevoo,M.A. van 't Hof,H.H. Kuper,M.A. van Leeuwen,L. B. A. Van De Putte,P.L.C.M. van Riel +5 more
TL;DR: The Modified DAS that included 28-joint counts were able to discriminate between high and low disease activity (as indicated by clinical decisions of rheumatologists) and are as valid as disease activity scores that include more comprehensive joint counts.
Journal ArticleDOI
American college of rheumatology preliminary definition of improvement in rheumatoid arthritis
David T. Felson,David T. Felson,Jennifer J. Anderson,Jennifer J. Anderson,Maarten Boers,Claire Bombardier,Claire Bombardier,Daniel E. Furst,Daniel E. Furst,Charles H. Goldsmith,Charles H. Goldsmith,Linda M. Katz,Linda M. Katz,Robert W. Lightfoot,Robert W. Lightfoot,Harold E. Paulus,Harold E. Paulus,Vibeke Strand,Vibeke Strand,Peter Tugwell,Peter Tugwell,Michael E. Weinblatt,Michael E. Weinblatt,H. James Williams,H. James Williams,Frederick Wolfe,Stephanie Kieszak +26 more
TL;DR: The results suggest that the definition of improvement presented is statistically powerful and does not identify a large percentage of placebo-treated patients as being improved, which the authors hope will be used widely in RA trials.
Journal ArticleDOI
Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.
Ravinder N. Maini,E W St Clair,F. C. Breedveld,Daniel E. Furst,Joachim R. Kalden,Michael H. Weisman,Josef S. Smolen,Paul Emery,G Harriman,Marc Feldmann,Peter E. Lipsky +10 more
TL;DR: Infliximab was well-tolerated; withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections did not exceed those in the placebo group.
Journal ArticleDOI
Cytokine Pathways and Joint Inflammation in Rheumatoid Arthritis
Ernest Choy,Gabriel S. Panayi +1 more
TL;DR: Current slow-acting antirheumatic drugs have limited efficacy and many side effects and do not improve the long-term prognosis of rheumatoid arthritis.
Journal ArticleDOI
A Comparison of Etanercept and Methotrexate in Patients with Early Rheumatoid Arthritis
Joan M. Bathon,Richard J. Martin,Roy Fleischmann,John Tesser,Michael Schiff,Edward C. Keystone,Mark C. Genovese,Mary Chester M. Wasko,Larry W. Moreland,Arthur L. Weaver,Joseph A. Markenson,Barbara K. Finck +11 more
TL;DR: Subcutaneous [corrected] etanercept acted more rapidly to decrease symptoms and slow joint damage in patients with early active rheumatoid arthritis.
Related Papers (5)
EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update
Josef S Smolen,Robert Landewé,Ferdinand C. Breedveld,Maya H Buch,Maya H Buch,Gerd R Burmester,Maxime Dougados,Paul Emery,Paul Emery,Cécile Gaujoux-Viala,Laure Gossec,Jackie L Nam,Jackie L Nam,Sofia Ramiro,Kevin L. Winthrop,Maarten de Wit,Daniel Aletaha,Neil Betteridge,Johannes W. J. Bijlsma,Maarten Boers,Frank Buttgereit,Bernard Combe,Maurizio Cutolo,Nemanja Damjanov,Johanna M. W. Hazes,Marios Kouloumas,Tore K Kvien,Xavier Mariette,Karel Pavelka,Piet L. C. M. van Riel,Andrea Rubbert-Roth,Marieke Scholte-Voshaar,David Scott,T. Sokka-Isler,John B. Wong,Désirée van der Heijde +35 more