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Fostamatinib trial showed mixed results in treating patients with RA

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Fostamatinib in combination with methotrexate displayed some effectiveness in treating patients with rheumatoid arthritis but no significant difference in an X-ray endpoint, according to its developer.

AstraZeneca and Rigel Pharmaceuticals are developing the first oral spleen tyrosine kinase inhibitor for rheumatoid arthritis (RA), according to a press release from AstraZeneca.

In the phase III study, researchers randomly assigned 923 patients with rheumatoid arthritis (RA) who had inadequate response to methotrexate (MTX) to two groups. During 24 weeks, the patients were treated with fostamatinib at either 100 mg twice daily or 100 mg twice daily for 4 weeks followed by 150 mg once daily for 20 weeks in combination with MTX or placebo and MTX. Primary endpoints were assessment of RA signs and symptoms using the ACR 20 response rate and X-ray endpoint in the modified Total Sharp Score (mTSS).

Patients treated with fostamatinib achieved significant ACR 20 response in the 100-mg twice daily group (49%; P<.001) and the 100-mg/150-mg group (44%; P=.006) compared with the placebo cohort (34%). There was not a significant difference, however, in mTSS for progression of joint damage in the 100-mg group (P=.252) or the 100-mg/150-mg group (P=.170) compared with placebo patients at 24 weeks.

Adverse events included hypertension, diarrhea, nausea, headache and nasopharyngitis, which were consistent with those seen in earlier studies, the release said.

“These top-line results provide important information on the efficacy and safety of fostamatinib and demonstrate that the compound has an effect on the signs and symptoms of rheumatoid arthritis,” Briggs W. Morrison, MD, executive vice president of Global Medicines Development at AstraZeneca, said in the release. “We will await the results of the remaining phase III studies … to further evaluate and characterize the profile of fostamatinib as a potential treatment for rheumatoid arthritis.”

Results of the other studies are expected later this year, according to AstraZeneca.