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Roche’s MabThera beats incumbent drug in pemphigus vulgaris phase 3

One year after starting treatment, 40.3% of patients were in sustained complete remission


Roche’s MabThera (rituximab) has outperformed mycophenolate mofetil in a phase 3 pemphigus vulgaris clinical trial.

MabThera, which is sold in some markets as Rituxan, won approval in the US in pemphigus vulgaris in June 2018 and was cleared for use in the European Union the following March.

The approvals made MabThera the first biologic approved for use in moderate to severe cases of the rare autoimmune skin disease and in Roche’s words, ‘the first major advancement in the treatment of the disease in more than 60 years’.

Roche won the approvals on the strength of data from a phase 3 trial that compared MabThera plus tapering oral corticosteroids to a standard dose of corticosteroids.

Now, Roche has presented data comparing MabThera to mycophenolate mofetil, one of the immunosuppressants physicians prescribe to spare patients from the side effects of long-term use of high-dose corticosteroids.

One year after starting treatment, 40.3% of patients who received MabThera were in sustained complete remission, compared to 9.5% in the control arm. That resulted in the trial hitting its primary endpoint.

“The PEMPHIX study showed that... Mabthera/Rituxan may be a superior treatment option to mycophenolate mofetil,” Levi Garraway, chief medical officer at Roche, said in a statement.

The study also met all of its secondary endpoints. Patients who received MabThera had a significantly lower cumulative oral corticosteroid dose, fewer flare-ups and a greater improvement on a dermatology quality of life index.

Roche is continuing to gather data in a 48-week follow-up period, giving it the chance to monitor the safety of MabThera after treatment completion or discontinuation. The safety data generated over the first 52 weeks of the trial were consistent with the MabThera safety profile seen in other clinical trials in pemphigus vulgaris and other autoimmune diseases.

The data could support Roche’s efforts to grow sales of MabThera in pemphigus vulgaris and thereby offset the drug’s falling market share in other indications. European sales of MabThera fell by 36% in the first half of 2019 in the face of competition from biosimilars. The decline in Japan was steeper still.

Falling sales in Europe and Japan were offset by a stronger performance in the US, where sales grew 4%. The result is that MabThera remains a big product for Roche, generating sales of CHF 3.3bn (£2.6bn) over the first half of the year.

Article by
Phil Taylor

14th October 2019

From: Research



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