Compiled based on choices from the RheumatologyNetwork Editorial Board.
- The European Commission approved the infliximab biosimilar Remsima for RA and ankylosing spondylitis, based on PLANETRA1,2 and PLANETAS3,4 studies, respectively.
- Efficacy of etanercept biosimilar Infinitam found similar to that of innovator etanercept in rheumatoid arthritis.5
Advances in RA Treatment
- The RACAT trial suggested that three older medications for RA used concomitantly may be as effective as biologics for non-responders to methotrexate, and substantially less expensive.6
- The OPTIMA trial demonstrated that initiating therapy with adalimumab as well as methotrexate increased the proportion of patients reaching a low disease activity target, compared with methotrexate monotherapy.7
- Two head-to-head trials: (1) Abatacept (Orencia) vs adalimumab (Humira), in which the agents were found equally effective with or without concomitant MTX, although the latter caused more injection-site reactions,8 and (2) IV tocilizumab vs adalimumab monotherapy in patients ineligible for continued MTX treatment.9 Tocilizumab proved superior in reducing RA symptoms but also caused potentially worrisome changes in blood test results.
- EULAR announced (but has not yet published) an update of its 2010 guidelines on RA.
- ACR updated its 2011 recommendations for treatment of juvenile idiopathic arthritis (JIA) to include new medications.10
- ACR and EULAR jointly updated classification criteria for systemic sclerosis.11
- ACR created two lists of tests and procedures that may be unnecessary, one for adults and one for younger patients.
- A EULAR task force clarified how to incorporate erosions when classifying RA.12
- EULAR issued recommendations for the imaging of joints in RA.13
New FDA Drug Approvals
- Intravenous golimumab (Simponi Aria), a TNF inhibitor, for moderate to severe RA, in combination with methotrexate. The dosing regimen is shorter and less frequent than the previously approved subcutaneous formulation.
- Subcutaneous tocilizumab (Actemra) for adults with moderate to severely active RA who have not responded to methotrexate or other DMARDs. An IV formulation was approved in 2010.
- Ustekinumab (Stelara), an IL-12/23 inhibitor, and certolizumab pegol, a TNF inhibitor, both for psoriatic arthritis.
- Anakinra for adults and children with neonatal-onset multisystem inflammatory disease (NOMID), a rare genetic disorder.
- Tocilizumab for polyarticular JIA in children at least 2 years old. (It was already approved for systemic JIA.)
- Canakinumab (Ilaris), an IL-1-beta inhibitor, for systemic JIA, in patients 2 years old or older.
Cause for Caution on Meniscal Tear
- A randomized study found nonsurgical measures as effective as meniscectomy after 6 and 12 months for patients with torn meniscus and evidence of osteoarthritis.14
New Alternative for ANCA-Associated Vasculitis
- Four weeks of rituximab therapy found as effective as a year and a half of cyclophosphamide and azathioprine for patients with severe antineutrophil cytoplasmic antibody-associated vasculitis. Side effects were similar.15
- Yoo DH, Racewicz A, Brzezicki J, et al. A phase 3 randomised controlled trial to compare CT-P13 with infliximab in patients with active rheumatoid arthritis: 54 week results from the PLANETRA study. Program and abstracts of the European League Against Rheumatism (EULAR) Congress 2013; June 12-15, 2013; Madrid, Spain. Abstract OP0068
- Yoo DH, Hrycaj P, Miranda P, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. (2013) 72:1613-1620
- Park W, Jaworski J, Brzezicki, et al. A randomised, double-blind, parallel-group, phase 1 study comparing the pharmacokinetics, safety and efficacy of CT-P13 and infliximab in patients with active ankylosing spondylitis: 54 week results from the PLANETAS study. Program and abstracts of the European League Against Rheumatism (EULAR) Congress 2013; June 12-15, 2013; Madrid, Spain. Abstract FRI0421
- Park W, Hrycaj P, Jeka S, et al.A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis. (2013) 72:1605-1612.
- Moctezuma JF, Martinez A, Enkerlin H, et al. Comparative, randomized, simple blind to evaluate efficacy and safety of Infinitam (etanercept), associated with methotrexate compared with Enbrel® (etanercept) associated with methotrexate in patients with moderate and severe rheumatoid arthritis. Program and abstracts of the European League Against Rheumatism (EULAR) Congress 2013; June 12-15, 2013; Madrid, Spain. Abstract THU0208.
- O'Dell JR, Mikuls TR, Taylor TH, et al; CSP 551 RACAT Investigators. Therapies for active rheumatoid arthritis after methotrexate failure. N Engl J Med. (2013) 369:307-318
- Smolen JS, Emery P, Fleischmann R, et al.Adjustment of therapy in rheumatoid arthritis on the basis of achievement of stable low disease activity with adalimumab plus methotrexate or methotrexate alone: the randomised controlled OPTIMA trial. Lancet. (2013) Oct 25. [Epub ahead of print]
- Weinblatt ME, Schiff M, Valente R, et al. Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis: findings of a phase IIIb, multinational, prospective, randomized study. Arthritis Rheum. (2013) 65:28-38
- Gabay C, Emery P, van Vollenhoven R, et al; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial.Lancet (2013) 381:1541-1550
- Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Care Res (Hoboken). (2013) 65:1551-1563
- van den Hoogen F, Khanna D, Fransen J, et al. 2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League Against Rheumatism Collaborative Initiative. Arthritis Rheum. (2013) 65:2737-2747
- van der Heijde D, van der Helm-van Mil AH, Aletaha D, et al. EULAR definition of erosive disease in light of the 2010 ACR/EULAR rheumatoid arthritis classification criteria. Ann Rheum Dis. (2013) 72:479-481
- Colebatch AN, Edwards CJ, Ãstergaard M, et al.EULAR recommendations for the use of imaging of the joints in the clinical management of rheumatoid arthritis.Ann Rheum Dis. (2013) 72:804-814
- Katz JN, Brophy RH, Chaisson CE, et al. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. (2013) 368:1675-1684
- Specks U, Merkel PA, Seo P, et al; RAVE-ITN Research Group. Efficacy of remission-induction regimens for ANCA-associated vasculitis.N Engl J Med. (2013) 369:417-427