REVOLADE HAS AN ESTABLISHED SAFETY PROFILE IN CHILD AND ADULT ITP PATIENTS1–5
REVOLADE is an established ITP medication, having been approved since 2010 with 8 years of clinical exposure across 5 clinical trials (EXTEND, RAISE, REPEAT, PETIT and PETIT2).1–5
THE EXTEND STUDY1
The long-term EXTEND study is a clinical trial that examined the safety and tolerability of REVOLADE:
- No new safety findings were observed in >300 patients treated with REVOLADE, lasting up to 8.76 years
- After 250 weeks of treatment, 15 of the original 302 patients were still on REVOLADE
- 92% of patients (n=277/302) experienced at least one AE of any grade. Of which, most were mild-moderate (Grade 1–2)
- The most frequent AEs were headache (28%), common cold (25%), and upper respiratory tract infection (23%)
- The most common serious AEs were cataracts (5%), pneumonia (3%), anaemia (2%) and ALT increase (2%)
THE RAISE STUDY2
- During the RAISE study, REVOLADE was generally well-tolerated
- Of the 197 patients enrolled, grade 3 or 4 AEs were experienced by 15% of patients (n=20/135) treated with REVOLADE, compared with 11% of patients (n=7/61) treated with placebo
- On-treatment serious bleeding (a serious AE) was significantly lower in patients receiving REVOLADE (n=1/135, <1%) compared with placebo (n=4/61, 7%; p=0.03)
Abbreviations: AE, adverse event; ALT, alanine transaminase; ITP, immune thrombocytopenia.
References
- Wong RSM, et al. Blood. 2017;130(23):2527–2536.
- Cheng G, et al. Lancet. 2011;377:393–402.
- Bussel JB, et al. Br J Haematol. 2013;160:538–546.
- Bussel JB, et al. Lancet Haematol. 2015;2(8):e315–325.
- Grainger JD, et al. Lancet. 2015;386(10004):1649–1658.
HCP19-C002j(1) June 2020.