For Biologics in Vasculitis, Decidedly Mixed Results

Mar 13, 2014

A multitude of new studies about biologics as alternatives in systemic vasculitis provide hints but not support for any strong conclusion.

Silva-Fernández L, Loza E, Martínez-Taboada VM, et al., (from the Systemic Autoimmune Diseases Study Group of the Spanish Society for Rheumatology [EAS-SER]). Biological therapy for systemic vasculitis: A systematic review.Semin Arth Rheum. 2014;43(4):542-557.

Most of the current evidence for biologics to treat systematic vasculitis (SV) doesn’t come from randomized clinical trials, but from uncontrolled, observational studies – which show mixed results in producing and sustaining remission, according to a new literature review.

In the 90 studies analyzed, rituximab (Rituxan) was the biological most often used in ANCA-associated vasculitis (AAV), followed by anti-tumor necrosis alpha (anti-TNFα) drugs.

Despite improvements from the former inevitably fatal outcome, thanks to the typical combination treatment of corticosteroids and immunosuppressants, relapses and treatment failure are frequent in SV patients. Thus biologics, including TNFα inhibitors, have often been prescribed as rescue therapy.

But results are often conflicting.

Among the many findings reviewed were the following.

For AAV:

• rituximab proved no less effective than cyclophosphamide for inducing remission -- and possibly better for patients with relapsing AAV. It may also be good for maintenance therapy;

• the TNFα inhibitor etanercept (Enbrel) was ineffective in maintaining remission in the form of AAV classified as granulomatosis with polyangiitis (GPA), but serious adverse events were reported;

• the anti-TNF drugs infliximab (Remicade) and adalimumab (Humira) were both good steroid-sparing agents.

But the review found few and inadequate data for other biologicals in AAV, such as tocilizumab and the selective co-stimulation modulator abatacept (Orencia). 

For large vessel vasculitis, such as giant cell arteritis (GCA):

• the interleukin-6 receptor antagonist tocilizumab (Actemra) might be effective in inducing remission, and

• etanercept was shown an effective steroid-sparing agent in one trial.

Given this wide variability, the authors concluded it’s not yet possible to make definite recommendations for the use of biologicals in vasculitis.

 

x