Only IMBRUVICA® has up to 8 years of safety follow-up in CLL, providing a consistent safety profile that helps deliver positive patient outcomes[1]
IMBRUVICA® is the only novel targeted therapy with a predictable long-term safety profile at up to 7 years of follow-up[2]
RESONATE-2: Prevalence of AEs in firstline CLL over time[2]*
RESONATE-2 reinforces IMBRUVICA®'s predictable long-term safety in CLL with no new safety signals observed at up to 7 years[2]
Adapted from Ghia P, et al. 2021.[2]
RESONATE: Prevalence of AEs in R/R CLL over time[3]
RESONATE reinforces IMBRUVICA®’s predictable long-term safety in relapsed/refractory CLL, with no unexpected AEs[3]
Adapted from Munir T, et al. 2019.[3]
Low discontinuation rates with IMBRUVICA®[4]*
94% remained on treatment in clinical trials[4]*
Nearly half of patients remained on IMBRUVICA® at up to 7 years of follow-up in the RESONATE-2 trial[2]
Only 4.76% discontinued due to toxicity in routine clinical practice in Spain[5]†
AEs are primarily Grade 1 or 2 and do not frequently lead to discontinuation of treatment.[6]
BTK inhibitor AEs[4][7]
Atrial fibrillation (AF)
- In one study with ~16-month follow-up, discontinuation due to AF was 1%[6]
Summary of product characteristics
AF occurrence (any Grade) was 7% with IMBRUVICA[4]
Real world
In the IBRORS trial, only 1 patient experienced Grade 3 AF, which did not lead to discontinuation†[5]
Major haemorrhage
Discontinuation of IMBRUVICA® due to major haemorrhage is rare[6]
Both AF and major haemorrhage led to discontinuation in 1% of patients on IMBRUVICA®[6]
Active dose management to address AEs enables most patients to continue benefiting from IMBRUVICA®[2]
For dose adjustments following AEs, visit the DOSING page and see 'Dosing considerations' section
IMBRUVICA® provides patients with clinically meaningful improvements in QoL[9][10]
FACIT-F
Functional assessment of chronic illness therapy - fatigue
56% of patients achieved improvements in FACIT-F with IMBRUVICA® vs. 43% with ofatumumab[10]‡
EQ-5D-5L UIS
EuroQol quality of life
utility index score
60% of patients achieved improvements in EQ-5D-5L UIS with IMBRUVICA® vs. 44% with Clb[9]§
EQ-5D-5L VAS
EuroQol quality of life
visual
analogue scale
65% of patients achieved improvements in EQ-5D-5L VAS with IMBRUVICA® vs. 52% with Clb[9]¶
Give your patients the reassurance of a predictable long-term safety profile with IMBRUVICA®[1][2][3]
Discover the long-term outcomes across all patient
subgroups with IMBRUVICA®
Learn about the simplicity of once-a-day
dosing with IMBRUVICA®
Back to IMBRUVICA® in CLL
*These included pneumonia, atrial fibrillation, thrombocytopenia, haemorrhage, neutropenia, rash, and arthralgia. Adverse reactions leading to dose reduction occurred in approximately 8% of patients. Pooled data from 1552 patients treated with IMBRUVICA® in 3 phase II clinical studies and 7 randomised phase III studies and from post-marketing experience.[11]
†IBRORS: Firstline IMBRUVICA® for patients with CLL in routine clinical practice in Spain. 84 patients, from a total of 269 included in IBRORS, received IMBRUVICA®.[5]
‡vs. 43% with ofatumumab (p=0.0101). 60 weeks follow-up.[10]
§vs. 44% with Clb (p=0.0089). Median follow-up was 5 years.[9]
¶vs. 52% with Clb (p=0.0329). Median follow-up was 5 years.[9]
AE=adverse event; AF=atrial fibrillation; BTK=Bruton's tyrosine kinase; Clb=chlorambucil; CLL=chronic lymphocytic leukaemia; EQ-5D-5L UIS=EuroQol quality of life utility index score; EQ-5D-5L VAS=EuroQol quality of life visual analogue scale; FACIT-F=Functional Assessment of Chronic Illness Therapy – Fatigue; R/R=relapsed/refractory; RCT=randomised controlled trial; SLL=small lymphocytic lymphoma.
