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SAFETY PROFILE
The safety evaluation of Reblozyl® in MDS is based on the double-blind, randomized, placebo-controlled, phase 3 MEDALIST trial (with 153 patients treated with Reblozyl® and 76 patients receiving placebo).1
The most commonly reported Grade 3 or higher adverse drug reactions (at least 2% of patients) included syncope/presyncope, fatigue, hypertension, and asthenia. The most commonly reported serious adverse drug reactions (at least 2% of patients) were urinary tract infection, back pain, and syncope.1
Most frequently reported adverse drug reactions
in at least 15% of patients receiving Reblozyl®1
For full details on adverse drug reactions in patients treated with Reblozyl® for MDS, please refer to the Summary of Product Characteristics (SmPC): SmPC in French, SmPC in Dutch.
SELECTED ADVERSE REACTIONS
Selected adverse reactions in MEDALIST trial1
- Hypersensitivity: Hypersensitivity-type reactions (including eyelid edema, drug hypersensitivity, swelling face, periorbital edema, face edema, angioedema, lip swelling, drug eruption) were reported in 4.6% of patients with MDS treated with Reblozyl® (2.6% placebo).
- Injection site reactions: Injection site reactions (including injection site erythema, injection site pruritus, injection site swelling and injection site rash) were reported in 3.9% of patients with MDS (placebo 0.0%). In clinical studies, all events were Grade 1 and none led to discontinuation.
- Immunogenicity: In an analysis of 260 patients with MDS who were treated with Reblozyl® and who were evaluable for the presence of anti-luspatercept antibodies, 8.8% of MDS patients tested positive for treatment emergent anti-luspatercept antibodies, including 3.5% of MDS patients who had neutralizing antibodies against Reblozyl®.
- Luspatercept serum concentration tended to decrease in the presence of neutralizing antibodies. There were no severe systemic hypersensitivity reactions reported for patients with anti-luspatercept antibodies. There was no association between hypersensitivity type reactions or injection site reactions and presence of anti-luspatercept antibodies.
- There were no severe systemic hypersensitivity reactions reported for patients with anti-luspatercept antibodies.
- There was no association between hypersensitivity type reactions or injection site reactions and presence of anti-luspatercept antibodies.
- Thromboembolic events (TEEs): No difference in TEEs was observed between Reblozyl® and placebo arms in MDS patients.
- Hypertension: Patients treated with Reblozyl® had an average increase in systolic and diastolic blood pressure of 5 mmHg from baseline not observed in patients receiving placebo. Hypertension was reported in 8.5% of patients with MDS (placebo 9.2%).
- In patients with MDS, Grade 3 events were reported for 5 patients (3.3%) treated with Reblozyl® and in 3 patients (3.9%) receiving placebo. No patient discontinued due to hypertension.
- Arthralgia: Arthralgia was reported in 5.2% of patients with MDS treated with Reblozyl® (placebo 11.8%).
- Bone pain: Bone pain was reported in 2.6% of patients with MDS treated with Reblozyl® (placebo 3.9%).
Selected adverse reactions in patients with MDS1
Higher instance of adverse reactions with Reblozyl® vs placebo in the MEDALIST trial
HYPERSENSITIVITY
4.6% Reblozyl®
2.6% Placebo
All events were Grade 1 or 2
INJECTION SITE REACTIONS
3.9% Reblozyl®
0% Placebo
All were Grade 1 and did not lead to treatment discontinuation
Other adverse reactions in MDS
IMMUNOGENICITY
8.8% of Reblozyl® patients tested positive for
treatment-emergent anti-luspatercept antibodies
THROMBOEMBOLIC EVENTS
No difference between Reblozyl® and Placebo
HYPERTENSION
8.5% Reblozyl®
9.2% Placebo
Grade 3 events were reported in 5 patients receiving Reblozyl® (3.3%);
none led to treatment discontinuation
ARTHRALGIA
5.2% Reblozyl®
11.8% Placebo
BONE PAIN
2.6% Reblozyl®
3.9% Placebo
DISCONTINUATIONS
Treatment discontinuation due to an adverse reaction occurred in 2.0% of patients with MDS. The adverse reactions leading to treatment discontinuation in the Reblozyl® arm were fatigue and headache.1
The safety evaluation of Reblozyl® in MDS is based on the double-blind, randomized, placebo-controlled, phase 3 MEDALIST trial (with 153 patients treated with Reblozyl® and 76 patients receiving placebo).1
Most frequently reported adverse drug reactions in at least 15% of patients receiving Reblozyl®1
The most commonly reported Grade 3 or higher adverse drug reactions (at least 2% of patients) included syncope/presyncope, fatigue, hypertension, and asthenia. The most commonly reported serious adverse drug reactions (at least 2% of patients) were urinary tract infection, back pain, and syncope.1
For full details on adverse drug reactions in patients treated with Reblozyl® for MDS, please refer to the Summary of Product Characteristics (SmPC): SmPC in French, SmPC in Dutch.
Selected adverse reactions in patients with MDS1
Higher instance of adverse reactions with Reblozyl® vs placebo in the MEDALIST trial
HYPERSENSITIVITY
4.6% Reblozyl®
2.6% Placebo
Hypersensitivity-type reactions (including eyelid edema, drug hypersensitivity, swelling face, periorbital edema, face edema, angioedema, lip swelling, drug eruption) were reported in 4.6% of patients with MDS treated with Reblozyl® (2.6% placebo).
INJECTION SITE REACTIONS
3.9% Reblozyl®
0% Placebo
Injection site reactions (including injection site erythema, injection site pruritus, injection site swelling and injection site rash) were reported in 3.9% of patients with MDS (placebo 0.0%). In clinical studies, all events were Grade 1 and none led to discontinuation.
Other adverse reactions in MDS
IMMUNOGENICITY
8.8% of Reblozyl® patients tested positive for treatment-emergent anti-luspatercept antibodies
In an analysis of 260 patients with MDS who were treated with Reblozyl® and who were evaluable for the presence of anti-luspatercept antibodies, 8.8% of MDS patients tested positive for treatment emergent anti-luspatercept antibodies, including 3.5% of MDS patients who had neutralizing antibodies against Reblozyl®.
- Luspatercept serum concentration tended to decrease in the presence of neutralizing antibodies. There were no severe systemic hypersensitivity reactions reported for patients with anti-luspatercept antibodies. There was no association between hypersensitivity type reactions or injection site reactions and presence of anti-luspatercept antibodies.
- There were no severe systemic hypersensitivity reactions reported for patients with anti-luspatercept antibodies.
- There was no association between hypersensitivity type reactions or injection site reactions and presence of anti-luspatercept antibodies.
THROMBOEMBOLIC EVENTS
No difference between Reblozyl® and Placebo
No difference in TEEs was observed between Reblozyl® and placebo arms in MDS patients.
HYPERTENSION
8.5% Reblozyl®
9.2% Placebo
Patients treated with Reblozyl® had an average increase in systolic and diastolic blood pressure of 5 mm Hg from baseline not observed in patients receiving placebo. Hypertension was reported in 8.5% of patients with MDS (placebo 9.2%).
- In patients with MDS, Grade 3 events were reported for 5 patients (3.3%) treated with Reblozyl® and in 3 patients (3.9%) receiving placebo. No patient discontinued due to hypertension.
ARTHRALGIA
5.2% Reblozyl®
11.8% Placebo
Arthralgia was reported in 5.2% of patients with MDS treated with Reblozyl® (placebo 11.8%).
BONE PAIN
2.6% Reblozyl®
3.9% Placebo
Bone pain was reported in 2.6% of patients with MDS treated with Reblozyl® (placebo 3.9%).
Only 2%
of MDS patients receiving Reblozyl® discontinued treatment due to an adverse reaction1
The adverse reactions leading to treatment discontinuation in the Reblozyl® arm were fatigue and headache.1