Tabalumab in rheumatoid arthritis patients with an inadequate response to
methotrexate and naive to biologic therapy: a phase II, randomized,
placebo-controlled trial.
Author(s): Genovese MC(1), Bojin S, Biagini IM, Mociran E, Cristei D, Mirea G, Georgescu L,
Sloan-Lancaster J.
Affiliation(s): Author information:
(1)Stanford University, Palo Alto, California 94304, USA. genovese@stanford.edu
Publication date & source: 2013, Arthritis Rheum. , 65(4):880-9
OBJECTIVE: Tabalumab, a fully human IgG4 monoclonal antibody, neutralizes soluble
and membrane-bound BAFF. The aim of this study was to examine the tolerability
and efficacy of tabalumab in patients with active rheumatoid arthritis receiving
methotrexate.
METHODS: In this randomized, double-blind, placebo-controlled, parallel,
multiple-dose study, patients who were naive to biologic therapy received
infusions of tabalumab (30, 60, or 160 mg) or placebo at weeks 0, 3, and 6 in
combination with methotrexate and were evaluated for 24 weeks. The primary
efficacy end point was the percentage of patients meeting American College of
Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16.
RESULTS: At week 16, the percentages of patients achieving an ACR20 response in
the 30-mg (57.6%), 60-mg (67.6%), and 160-mg (51.5%) groups were significantly
greater than the percentage of patients achieving an ACR20 response in the
placebo group (29.4%; P<0.05). There were initial transient increases from
baseline in the frequency of CD20+ and IgD+/CD27- B cells, followed by
reductions, although B cells were not completely depleted. Also, the frequency of
IgD-/CD27+ B cells increased in all tabalumab groups compared with the placebo
group and returned toward baseline levels by the end of the study. The incidence
of adverse events was similar across all treatment groups; no deaths occurred.
Serum IgM levels decreased significantly in all tabalumab groups combined
compared with the placebo group. There were no significant decreases in serum IgG
or IgA levels in the tabalumab groups compared with the placebo group.
CONCLUSION: Tabalumab treatment significantly reduces the signs and symptoms of
rheumatoid arthritis and has a safety profile similar to that seen with placebo
treatment.
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