High Points of Rheumatology in 2013

Compiled based on choices from the RheumatologyNetwork Editorial Board.

Biosimilars

• The European Commission approved the infliximab biosimilar Remsima for RA and ankylosing spondylitis, based on PLANETRA^1,2 and PLANETAS^3,4  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.

New Guidelines

• 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

References:

• 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, Østergaard 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