Incidence of corneal adverse events in patients with multiple myeloma and their clinical and economic impact: a real-world retrospective cohort study

Background We aimed to systematically assess the effectiveness and tolerability of erenumab in a clinical setting, specifically a tertiary headache center. Methods This was a retrospective cohort study at the John Graham Headache Center of Brigham and Women’s Hospital. All patients who received erenumab from a headache specialist at the Center from 17 May 2018 to 31 January 2019 were included. Patients were contacted and underwent a structured clinical interview including information about erenumab use, perceived benefit, adverse events (AEs), and a global assessment of benefit versus drawbacks. Chart review was performed for patients who could not be contacted. Results Four hundred and forty-four patients were initially identified and 418 were eligible. Two hundred and ninety-five participants completed the structured clinical interview portion of the study (response rate 70.6%). Seventy-four patient charts were additionally reviewed. Two hundred and forty-one participants had used erenumab. One hundred and sixty nine (70%) of participants experienced at least one adverse event, with constipation (43%), injection site reaction (24%), fatigue (15%), worsening headache (12%), and dizziness (11%) the five most commonly reported AEs. One hundred and sixty-eight participants (69.7%) felt that the benefits of erenumab outweighed any drawbacks. One hundred and fifty-one participants (62.7%) planned to continue using erenumab. Cost of treatment was cited by 12% of participants as a reason for either not starting or for stopping erenumab. Of patients who had an increase in dose due to lack of or partial efficacy, 46.5% felt that the dose increase was helpful. We identified one case of unintended pregnancy in our study population. Conclusions This large “real-world” study validates the findings of benefit of erenumab observed in clinical trials. Although adverse events were far more common in this population than in clinical trials, the planned continuation rate was relatively high. The substantial discrepancy between adverse events seen in clinical practice compared with clinical trials suggests systematic differences between clinical trial participants and patients who receive the treatment in clinical practice, or may indicate suboptimal ascertainment of adverse events in the trials. Clinicians should continue to be vigilant for adverse events in clinical practice.

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Safety and efficacy of bone-modifying agents among multiple myeloma patients: A retrospective cohort study

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155221996039 ◽

2021 ◽

pp. 107815522199603

Author(s):

Christina Billias ◽

Megan Langer ◽

Sorana Ursu ◽

Rebecca Schorr

Keyword(s):

Multiple Myeloma ◽

Cohort Study ◽

Zoledronic Acid ◽

Retrospective Cohort Study ◽

Retrospective Cohort ◽

Osteonecrosis Of The Jaw ◽

Safety And Efficacy ◽

Modifying Agent ◽

Skeletal Related Events ◽

Agent Group

Objective To determine the incidence of skeletal-related events among multiple myeloma patients who received chemotherapy without a bone-modifying agent (zoledronic acid and denosumab) versus those who received chemotherapy with a bone-modifying agent. The secondary objective was to determine the incidence of skeletal-related events in patients without any prior history of skeletal-related events and who were treated with zoledronic acid every four weeks versus those who received zoledronic acid at an extended interval of every twelve weeks. Additional secondary objectives included the incidence of nephrotoxicity, hypocalcemia and osteonecrosis of the jaw in all patients. Methods This institutional review board-approved, retrospective cohort study included patients 18 to 89 years old with a diagnosis of multiple myeloma, who were being treated with chemotherapy between July 1, 2016 and October 31, 2019. Safety and efficacy were assessed through analysis of pertinent data collected: patient demographics, baseline skeletal-related events, development of new skeletal-related events, number and type of bone-modifying agent doses administered, and drug-related toxicities such as nephrotoxicity, hypocalcemia, and osteonecrosis of the jaw. Results A total of 73 patients were included. New skeletal-related events occurred in 12 patients (27%) in the chemotherapy without a bone-modifying agent group and in 5 patients (17%) in the chemotherapy with a bone-modifying agent group (OR = 0.56, 95% CI [0.172–1.8]; P = 0.32). The incidence of skeletal-related events was similar among patients receiving zoledronic acid every four weeks versus every twelve weeks in patients without a prior skeletal-related event (N = 0 vs. N = 2 respectively; P = 0.47). There were no statistically significant differences observed in each of the three secondary safety endpoints: incidence of hypocalcemia, nephrotoxicity and osteonecrosis of the jaw. Conclusion Multiple myeloma patients receiving chemotherapy without a bone-modifying agent had higher rates of skeletal-related events compared to those being treated with chemotherapy and a bonemodifying agent. Our results highlight the benefit of utilizing bonemodifying agents for the prevention of skeletal-related events in all multiple myeloma patients being treated with chemotherapy.

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