Comprehensive safety evaluation of isatuximab in multiple myeloma using disproportionality analysis of FAERS and meta-analysis of randomized controlled trials.

Introduction

Multiple myeloma (MM) is a prevalent hematological cancer marked by the uncontrolled plasma cell growth in the bone marrow and an elevated monoclonal protein production. This condition leads to high morbidity and mortality following end-organ failures, as well as aggravating infections caused by both the disease and its therapy 1 , 2 . Over the past few years, the introduction of immunomodulatory drugs and proteasome inhibitors has significantly altered the disease course and enhanced the prognosis for MM. Despite these advancements, treating MM remains challenging and complicated attributable to the elevated recurrence of the disease and resistance to therapeutic interventions 3 .

The pressing need for new treatment approaches has spurred the emergence of various immunotherapy-based approaches in in recent times. Among these, the emergence of monoclonal antibodies (mAbs), including drugs targeting CD38 (daratumumab and isatuximab) and SLAMF7 (elotuzumab), represents a significant advancement in the therapeutic management of relapsed and/or refractory MM 4 – 6 . Isatuximab is a chimeric humanized IgG1 mAb that targets a particular epitope on the CD38 protein present on human cell surfaces 7 . It has been granted approval to treat relapsed or refractory MM and can be administered intravenously. Isatuximab is approved in many countries throughout the world, including the European Union 8 , the United States 9 , and Japan 10 . CD38 is a type II transmembrane protein which functions as both a receptor and a versatile ectoenzyme. It is considered as an appealing therapeutic target for MM due to its generous appearance on both normal plasma cells and MM cells, while being minimally present on normal myeloid and lymphoid cells 11 , 12 .

Anti-CD38 mAbs represent a groundbreaking immunotherapeutic approach in the treatment of MM. Among these, isatuximab has expanded the therapeutic resources available to clinicians by providing an additional treatment option for patients with this challenging disease. To enhance our understanding of isatuximab’s safety profile, this study undertakes a comprehensive evaluation utilizing data from the FDA Adverse Event Reporting System (FAERS). Additionally, we conduct a systematic review and meta-analysis of randomized clinical trials (RCTs) to provide a thorough assessment of the adverse events (AEs) associated with isatuximab. By integrating these sources of data, our aim is to offer a detailed and nuanced evaluation of the safety profile of isatuximab in clinical practice.

Materials and methods

Signal generation

Data source

The data resource for the present analysis was the FAERS, which is among the largest repositories of spontaneous reports. FAERS is a publicly accessible database that gathers reports of medication errors and AEs from pharmaceutical companies, healthcare providers, consumers, and medical professionals over the globe. This database is updated quarterly by the Food and Drug Administration (FDA). The study incorporated data available through March 2024. Potential adverse events were investigated at the preferred term level of Medical Dictionary for Regulatory Activities (MedDRA) to assess any correlation with the drug isatuximab 13 . Data was retrieved from the FAERS using OpenVigil 2.1 and MedDRA version 24.

Disproportionality analysis

Data mining algorithms based on Frequentist methods were employed to determine disproportionality 14 . The proportional reporting ratio (PRR) with Chi-squared and the reporting odds ratio (ROR) with a 95% confidence interval (CI) were computed. “A PRR ≥ 2 with, count of co-occurrence ≥ 3, and the lower limit of 95% CI of ROR exceeding 1 is considered a positive signal as per Evans criteria” 15 .

Signal refinement

The search query for drug names in OpenVigil includes all roles of the drug, such as “primary suspect, secondary suspect, concomitant, and interacting”. Signal refinement was achieved by restricting the drug classifications to ‘Primary Suspect’ only, thereby excluding all other roles to generate more focused results on possible causal direct associations between the drug and AEs.

Meta-analysis

The study protocol was registered with The International Prospective Register of Systematic Reviews (PROSPERO - CRD42022379632).

Data source

The literature was thoroughly and methodically searched to identify RCTs evaluating the safety and treatment-emergent adverse events (TEAEs) associated with Isatuximab in MM patients. This included an extensive search across resources such as PubMed, EMBASE, and ClinicalTrials.gov., utilizing both free-text keywords and Medical Subject Headings (MeSH) terms. Further, the citation lists of the obtained articles were meticulously reviewed to find potentially relevant studies.

Screening and selection

The present study incorporated RCTs evaluating isatuximab in both relapsed or refractory MM patients who had undergone one to three prior lines of therapy, as well as newly diagnosed MM patients, regardless of gender, and all participants were aged 18 years or older. Isatuximab was administered either as monotherapy or in conjunction with other therapeutic agents. RCTs evaluating the safety and tolerability outcomes and published in English were considered for inclusion. Trials focused solely on efficacy, those with unextractable data, or published in non-English languages were excluded. Additionally, observational studies, non-randomized trials, and case-control studies were not considered for inclusion in this study. During the preliminary eligibility screening phase, titles and abstracts were reviewed independently by two authors (MF KT, and MM). Following this, the full text of the studies deemed eligible were evaluated based on the eligibility criteria in the secondary screening phase. To resolve any discrepancies, a third author (BTY) was also engaged, and discussions took place at both these stages of the screening process 16 .

Data extraction and quality assessment

Data were systematically compiled using a pre-established data extraction form, which included variables such as author details, year of publication, duration of study, research design, sample size, criteria for defining myeloma, geographical setting, follow-up, and TEAEs. The methodological quality of each study was evaluated utilizing the Cochrane Risk of Bias Tool (ROB 2.0) (Figure S1 ) 17 .

Statistical analysis

The aggregated risk of TEAEs associated with isatuximab-based therapies compared to the control group was quantified using a risk ratio (RR) accompanied by a 95% CI. The effect estimates were combined using a random-effects meta-analysis approach 18 . The heterogeneity between the studies was evaluated using the I 2 statistic and the Q test 19 . There was no use of a funnel plot to investigate possible small-study biases due to the limitation of having fewer than ten trials available for inclusion in the analysis 20 , 21 . The R studio was employed to perform statistical analysis. It was decided that statistical significance was indicated by a p-value of less than 0.05.

Results

Based on the analysis of the FAERS quarterly reports, a total of 2325 AE reports related to isatuximab have been submitted to the FDA (Table 1 ). Men predominated in the study population, comprising 1156 participants (49.7%), compared to 960 women (41.3%). Among different age categories, the 64–85 years age group exhibited a higher incidence of AEs, with 1326 cases (57.0%), compared to 640 cases (27.5%) in the 18–64 years age group. Two countries, France and Germany, accounted for a substantial portion of the AE reports, with 655 reports (28.2%) and 580 reports (24.9%) respectively.

Disproportionality analysis

The disproportionality analysis results for isatuximab revealed that the drug is linked to AEs across various System Organ Classes (SOCs), such as blood and lymphatic system disorders, respiratory, thoracic and mediastinal disorders, cardiac disorders, infections and infestations, renal and urinary disorders, vascular disorders among others (Table 2 ). AEs including neutropenia, pneumonia, infusion-related reactions, thrombocytopenia, acute kidney injury, and anemia were observed to occur more frequently in association with isatuximab therapy. The majority of the AEs maintained their signal scores when refined to the drug role as ‘primary suspect’, although some did not. The signal scores for pulmonary hypertension, respiratory tract infection, atrial flutter, and peripheral neuropathy were no longer significant after refinement.

Meta-analysis

We carried out a systematic evaluation of the literature across multiple resources using advanced search strategy (Table S1 ). A total of 355 citations were identified. Initial screening led to the exclusion of 279 citations. Subsequent full-text reviews were conducted on six citations, from which three eligible RCTs published between 2019 and 2022 were included (Fig. 1 ) 22 – 24 . These studies were conducted across various countries in Europe, the Americas, and the Asia-Pacific region (Table 3 ). All the three studies were having an active control group, enrolling 1258 patients, with 659 (52.4%) receiving Isatuximab treatment and 599 (47.6%) allocated to the control group.

TEAEs

The isatuximab therapy was associated with a total of 1135 AEs (Table 4 ), compared to 906 AEs reported in the control group. Within the isatuximab group, 58% (660/1135) of these AEs were graded as three or higher, whereas 59% (542/906) of AEs in the control group were of grade three or above. Hematological events, including neutropenia, thrombocytopenia, anemia, and leukopenia, constituted the majority of AEs observed. Specifically, in the isatuximab group, neutropenia was reported in 398 cases, with 318 of these classified as grade three or higher. Thrombocytopenia was observed in 337 cases, of which 142 were grade three or above, and anemia was documented in 353 cases, with 105 being grade three or above.

Risk of neutropenia

In the study, 398 out of 659 patients (60%) developed neutropenia-all grades in the Isatuximab group whereas 237 out of 599 patients (40%) had neutropenia-all grades in control group (Fig. 2 a). The Isatuximab group exhibited an elevated risk of neutropenia with a RR of 1.61 (95% CI: 0.81–3.21; p = 0.1734). There was significant heterogeneity observed (I 2 = 97%, p < 0.0001). However, for neutropenia grade 3 and above, the Isatuximab group showed a statistically significant higher risk (RR = 2.13, 95% CI: 1.12–4.03, p = 0.0207), with considerable heterogeneity noted (I 2 = 95%, p < 0.01) (Fig. 2 b).

Risk of thrombocytopenia

The results demonstrated a 7% increased risk of thrombocytopenia (RR = 1.07, 95% CI: 1.01–1.14, p = 0.0213) (Fig. 3 a) in the isatuximab therapy. However, for thrombocytopenia grade 3 or higher, there was a statistically significant 30% increased risk associated with isatuximab (RR = 1.30, 95% CI: 1.03–1.64, p = 0.0244), as depicted in Fig. 3 b.

Risk of anemia

In the isatuximab group, 353 patients (54%) experienced anemia of all grades, compared to 306 patients (51%) in the control group (Figure S2). The RR for anemia was 1.01 (95% CI: 0.99–1.02, p = 0.3685), with moderate heterogeneity (I 2 = 55%, p = 0.11). Additionally, the pooled estimate showed a 10% protective effect against the risk of grade three or higher anemia (RR = 0.90, 95% CI: 0.67–1.20, p = 0.4559) in the isatuximab regimen (Figure S3).

Risk of bronchitis

Two studies comparing the isatuximab group to the non-isatuximab group reported bronchitis of all grades as an outcome measure, with a RR of 2.20 (95% CI: 1.47–3.29, p = 0.0001). This indicates a statistically significant elevated risk of bronchitis (all grades) in the isatuximab group (Figure S4). Contrarily, the pooled analysis of two studies comparing the risk of grade 3 or higher bronchitis has revealed a RR of 3.70 (95% CI: 0.80–16.99, p = 0.0928) (Figure S5).

Risk of pneumonia

The pooled analysis reported that 82 (25%) patients in the isatuximab regimen and 54 (20%) in the control arm developed pneumonia of all grades. The associated RR was 1.22 (95% CI: 0.90–1.65; p = 0.2032), with a low heterogeneity observed among the studies (Figure S6). Additionally, for pneumonia of grade 3 or above, the risk in the isatuximab group was increased by 29% (RR = 1.29, 95% CI: 0.89–1.88, p = 0.1760) (Figure S7).

Risk of upper respiratory tract infection

The analysis comprised 107 out of 329 (33%) individuals experiencing upper respiratory tract infections of all grades, compared to 71 out of 271 (26%) patients in the control arm (Figure S8). There observed a statistically significant elevated risk (RR = 1.56, 95% CI: 1.18–2.07, p = 0.0019). Additionally, two studies assessed upper respiratory tract infections of grade 3 and above between the isatuximab and non-isatuximab groups. The reported RR was 2.81 (95% CI: 0.79–10.02, p = 0.1115) (Figure S9).

Risk of diarrhea

In the isatuximab group, 103 out of 329 (31%) patients experienced diarrhea of all grades, compared to 64 out of 271 (24%) patients in the control group. The RR was 1.28 (95% CI: 0.98–1.67, p = 0.0664) (Figure S10). For diarrhea of grade 3 or above, 8 patients in the isatuximab group were affected, with a RR of 1.50 (95% CI: 0.45–4.96, p = 0.5080) compared to 4 patients in the control arm (Figure S11).

Discussion

The examination of AEs correlated with the administration of isatuximab has provided nuanced insights into its safety profile. The disproportionality analysis identified several AEs associated with isatuximab, including noteworthy signals for neutropenia, febrile neutropenia, pneumonia, atrial flutter, lymphopenia, and tumor lysis syndrome. Furthermore, the isatuximab group exhibited a higher overall incidence of AEs in comparison to the control group, with a notable proportion of grade three or above events.

Hematologic toxicity, particularly neutropenia, is the most commonly reported AE with isatuximab treatment. Neutropenia was a frequent occurrence in both clinical trials and real-world studies. For instance, Tagami et al. 25 reported serious hematologic AEs in 19.2% of patients, emphasizing the need for careful monitoring and timely intervention with supportive care, such as granulocyte colony-stimulating factor (G-CSF) administration. Although hematologic AEs are significant, they remain manageable with proper clinical protocols, ensuring that patients can continue therapy with minimized interruptions. Infusion reactions are another well-documented 25 , 26 concern associated with isatuximab. Occurring in approximately 18.3% of patients, these reactions are typically mild to moderate and can be mitigated with premedication, including corticosteroids, antihistamines, and acetaminophen. These reactions are most common during the first infusion, necessitating close monitoring during the early stages of treatment. While generally manageable, they underline the importance of preparedness in clinical settings to handle more severe cases should they arise. Isatuximab’s immunosuppressive effect, especially its induction of hypogammaglobulinemia, contributes to an elevated risk of infections. Rodríguez et al. 27 highlighted that 8.3% of patients experienced serious infections during treatment. This risk is heightened by the drug’s impact on the immune system, necessitating regular monitoring of immunoglobulin levels. In some cases, intravenous immunoglobulin (IVIG) therapy may be required to prevent serious infections, especially in patients predisposed to recurrent infections.

Isatuximab has demonstrated significant efficacy in combination regimens, particularly when paired with agents like pomalidomide and dexamethasone. Clinical studies 22 , 28 have shown improved progression-free survival (PFS) and overall response rates (ORR) with these combinations. For instance, the combination of isatuximab with carfilzomib and dexamethasone resulted in a 47% reduction in disease progression (hazard ratio [HR] = 0.531, p = 0.0013), though there was no significant increase in overall response rates. Notably, while the combination regimens do not drastically alter the incidence of AEs, some differences, such as higher neutropenia rates in the pomalidomide-dexamethasone cohort and increased hypertension in the carfilzomib-dexamethasone cohort, were observed. These findings highlight the importance of selecting appropriate combination therapies based on patient-specific factors to minimize risk while maximizing efficacy.

In comparing isatuximab with daratumumab, another CD38-targeting mAb, recent reviews 29 , 30 indicate that the AE profiles of the two therapies are similar. Grade 3 or higher AEs, such as neutropenia, lymphopenia, leukopenia, thrombocytopenia, and anemia, were common across both therapies. These AEs were generally manageable with dose modifications. The comparative safety and efficacy of isatuximab and daratumumab suggest that either option could be considered based on patient tolerance and prior treatment history.

A pharmacovigilance investigation documented 274 cases of tumor lysis syndrome associated with mAbs in patients with MM 31 . They postulated that mAbs could enhance an individual’s risk of developing tumor lysis syndrome in patients with MM. This hypothesis was supported after conducting a sensitivity analysis that excluded confounding factors such as patient-related and indication-related variables. In a pharmacovigilance analysis conducted by Moore et al. 32 16 instances of hepatitis-B virus (HBV) reactivation were noted in individuals undergoing isatuximab or daratumumab treatment. The association was found to be statistically significant for both daratumumab (ROR = 4.76) and isatuximab (ROR = 9.31).

Our study integrates evidence from disproportionality analysis of FAERS data and meta-analyses of RCTs to explore the association between isatuximab and TEAEs. However, there are some inherent limitations. While the findings of relevant AEs from the FAERS database are significant, the reported signals observed in our analysis suggest plausible associations but do not demonstrate causality 33 . The FAERS database is also reliant on spontaneous reporting 34 , which can introduce reporting bias and underreporting of AEs, particularly for milder or less recognized events. Furthermore, there may be incomplete or inaccurate information in the FAERS entries, limiting the ability to fully assess the context and severity of the AEs reported.

Another limitation is the relatively small number of included RCTs, given that isatuximab has only recently been approved and research is still ongoing. This small sample size may affect the generalizability of the findings to broader patient populations or different clinical settings. Furthermore, the limited number of included RCTs precluded the possibility of conducting a publication bias test. All the included RCTs were open-label studies, raising concerns about the quality of outcome measurement, as the lack of blinding can introduce bias in reporting adverse events or other outcomes. Additionally, RCTs, by their design, often do not facilitate extensive, long-term follow-up, which may result in the underreporting of uncommon or delayed AEs. The limited duration of follow-up in these trials may prevent the detection of long-term safety concerns, which are critical for chronic conditions like multiple myeloma, where treatment is often prolonged. Another potential limitation is that most trials included combination therapies, making it difficult to isolate AEs specifically attributable to isatuximab monotherapy versus the co-administered agents. Finally, the lack of diversity in the patient populations included in the trials, in terms of age, comorbidities, and ethnic backgrounds, may limit the applicability of the results to broader real-world populations, where these factors can influence both efficacy and safety outcomes.

Conclusion

The real-world AE monitoring of the anti-CD38 antibody isatuximab is ongoing. The majority of the adverse events (AEs) found in this investigation matched those listed on the product label, although additional AEs not mentioned on the product label were also discovered. Hematological manifestations, specifically neutropenia and anemia, emerged as predominant AEs, underscoring the importance of vigilant hematologic monitoring during isatuximab therapy. These findings necessitate a meticulous and individualized approach to patient care, with heightened awareness of potential AEs. Clinicians should integrate these results into their risk-benefit assessments when considering isatuximab in therapeutic strategies.

Electronic Supplementary Material

Below is the link to the electronic supplementary material.

Supplementary Material 1

Acknowledgements

MFKT and BTY thank Indian Council of Medical Research (ICMR) for the assistance provided through research fellowship.

Author contributions

MFKT and MM were responsible for conceptualizing the study and designing the methodology. MFKT and BTY performed the formal analysis and generated the results. The original draft of the manuscript was prepared by MFKT and BTY, while DB conducted thorough and critical revisions to ensure the incorporation of crucial content. DB also supervised the entire process. All authors have read and approved the final manuscript.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data availability

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

Declarations

Competing interests

The authors declare no competing interests.

Footnotes

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Associated Data

Supplementary Materials

Supplementary Material 1

Data Availability Statement

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.