SOLIRIS (eculizumab): The first treatment specifically approved for PNH

Clinical Studies

Is SOLIRIS right for me?

The benefits of SOLIRIS® (eculizumab) were studied in 3 clinical trials.

Study 1 (TRIUMPH Study)

To qualify for the TRIUMPH study, all patients were required to have at least 4 blood transfusions in the 12 months before the study began. A total of 87 PNH patients participated in this study.

In this study, 43 PNH patients received SOLIRIS, and 44 PNH patients received a placebo (an infusion with no SOLIRIS in it) Neither the patients nor the doctors knew which patients were receiving the drug.

The study lasted 26 weeks. All patients who received SOLIRIS had a dramatic reduction in red blood cell destruction (hemolysis) compared to no change in hemolysis in the patients who received a placebo. The dramatic reduction with SOLIRIS was sustained throughout the study.

Clinical StudiesThis reduction in hemolysis led to improvements in anemia in the SOLIRIS treated group as demonstrated by a 73% reduction in units of blood transfused compared to patients taking the placebo. Approximately half of the patients treated with SOLIRIS did not require a blood transfusion during the study (compared to all patients needing a transfusion in the placebo group).

By the 3rd week of the study, patients on SOLIRIS reported less fatigue and better health-related quality of life compared to the patients taking the placebo.

The most common side effects reported in the SOLIRIS group were headache, runny nose, back pain, and nausea. The number of headaches that occurred was similar in the SOLIRIS and placebo groups after the first 2 weeks of therapy.

Study 2 (SHEPHERD Study)

In this study, all 97 PNH patients were given SOLIRIS for one year. Treatment with SOLIRIS reduced hemolysis in all patients for the entire study. The reduction in hemolysis resulted in a reduction of blood transfusions, improvement in fatigue and health-related quality of life, very similar to the results from Study 1. In addition, SOLIRIS was found to have a similar safety profile to Study 1 and was well tolerated over the Study period of 1 year.

Study 3 (Extension Study)

187 PNH patients taking SOLIRIS have been observed in a long-term study. Some of these PNH patients were taking SOLIRIS for over 5 years. These patients sustained a reduction in hemolysis for the length of the study (ranging from 10 to 54 months). In addition, patients had fewer blood clots during the study period than during the same period of time prior to treatment with SOLIRIS.

Next: Frequently Asked Questions About SOLIRIS

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Patients should be vaccinated with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS. Revaccinate according to current medical guidelines for vaccine use.

Patients should be monitored closely for early signs of meningococcal infections and evaluated immediately if infection is suspected, and treated with antibiotics if necessary.

The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, fatigue, and cough.

Please see important safety information (including boxed warning) as well as the complete prescribing information.