*For medical professionals only
The research on AD biotherapy keeps going, and the latest research results are frequently highlighted.
On March 25, 2022 (US Eastern Time, 12 hours later than Beijing time), the annual American Academy of Dermatology (AAD) annual meeting was successfully opened in Boston, Massachusetts, USA . At present, the AAD annual meeting is in full swing and will last until March 29, 2022 (US Eastern Time, 12 hours later than Beijing time). Dermatology experts from all over the world gathered together to bring the most cutting-edge academic feast of dermatology to the majority of dermatologists.
01
Continuously exciting,Focus on the cutting-edge progress in AD biotherapy
Atopic dermatitis (AD), as a common chronic, relapsing, systemic and refractory disease, has always been the focus of dermatology. In recent years, with the deepening of basic and clinical research, many breakthroughs have been made in the field of AD, and the successive advent of innovative drugs has rewritten the treatment pattern of AD. For example, the advent of the biological agent dupilumab has brought revolutionary changes to the treatment of AD, and the cutting-edge progress of dupilumab is undoubtedly the focus of the AD treatment field at this AAD annual meeting.
So, at this AAD annual meeting, what are the latest research data of dupilimumab in the field of AD treatment? “Medical Skin Channel” specially extracts the essential points for readers.
02
Comprehensive benefit,Biologics meet the multiple needs of AD patients
The main clinical manifestations of AD are skin lesions and severe pruritus. In addition, AD can also affect patients’ sleep, quality of life, work efficiency, etc. Therefore, in addition to symptom improvement, the treatment needs of AD patients also include improvements in multiple dimensions such as sleep quality, quality of life, and work efficiency. The current AAD annual meeting also released the data related to dupilumab, suggesting the multiple benefits of dupilumab in the treatment of AD.
Restore skin barrier function and realize full benefits: This year’s AAD annual meeting announced the improvement of dupilimumab by transdermal water loss (TEWL) evaluation Data from a study of skin barrier function in adolescents and adults with moderate-to-severe AD. The results showed that from the 2nd week of treatment, the median TEWL at the AD skin lesions was significantly lower than the baseline; at the 16th week of treatment, the median TEWL at the AD skin lesions was not significantly different from that of healthy volunteers (Figure 1). )[1]. In the 16th week of treatment, the patient’s eczema area and severity index (EASI), atopic dermatitis severity index (SCORAD), peak pruritus numerical rating scale (PP-NRS), sleep quality NRS, and patient eczema self-examination score scale (POEM), Dermatology Life Quality Index (DLQI)/Childhood Dermatology Life Quality Index (CDLQI) and other scores also decreased (Figure 2) [1].
Figure 1: Median TEWL improvement over time at 16 weeks of treatment
Figure 2: Improvement in symptoms, signs, and patient-reported outcomes (PRO) at 16 weeks of treatment
Quick, lasting improvement in sleep quality: Presenting the results of the DUPISTAD study at this AAD Annual Meeting, Dupree Monoclonal antibody treatment for 12 weeks significantly reduced sleep disturbance NRS, PP-NRS, SCORAD, and SCORAD sleep VAS scores in adult patients with moderate-to-severe AD (Figure 3) [2]. In addition, the long-term research data of the pivotal Phase III clinical trials of dupilumab in the treatment of AD* in adults, adolescents and children have also been released, all showing that 1 year of dupilumab treatment can rapidly and continuously improve AD Sleep quality of patients [3].
Figure 3: Improvements in sleep, pruritus and SCORAD scores at 12 weeks of treatment
Rapid, lasting improvement in quality of life: RELIEVE-AD evaluates dupilimumab improving the lives of adults with moderate-to-severe AD The results of the study were also released at the current AAD annual meeting [4]. From the data, it can be seen that the patients’ DLQI scores improved significantly at 1 month of treatment and continued to 30-36 months (Fig. 4) [4]. After 1 month of treatment and 30 to 36 months, the proportion of patients whose DLQI score improved by ≥4 points from baseline was 76.1% and 84.9%, respectively [4]. After 1 month of treatment, the proportion of patients with DLQI score of 0/1 increased significantly, and the proportion reached 52.5% after 30 to 36 months of treatment (Figure 5) [4].
Figure 4: Improvement of DLQI score after 30-36 months of treatment
Figure 5: DLQI 0/1 response from 30 to 36 months of treatment
Improve work productivity, improve mobility impairment: The RELIEVE-AD study also evaluated dupilumab in adults with moderate-to-severe AD The effect of work limitation and mobility impairment in patients [4]. The results showed that the work limitation and activity disorder were significantly improved after 1 month of treatment, and lasted to 30 to 36 months (Figure 6, Figure 7). The results of this study were also announced at the current AAD annual meeting [4].
Figure 6: 30-36 months of treatment, improvement in work limitation
Figure 7: 30~36 months of treatment, the improvement of movement disorders
03
Durable efficacy, Biologics help AD treatment “long-term stability”
AD is a chronic, relapsing disease that requires long-term treatment. With the accumulation of research results and practical experience, dupilumab therapy has also been further explored in the long-term management of AD. The data of the 30-36-month RELIEVE-AD study and the 4-year open-label extension (OLE) study were successively announced at this AAD annual meeting, demonstrating the long-term efficacy of dupilimumab in the treatment of AD and security.
Good long-term efficacy and safety: This year’s AAD annual meeting announced that dupilimumab in the treatment of adults with moderate-to-severe AD OLE research data [5]. The data showed that dupilumab treatment continued to maintain the improvement of EASI and PP-NRS scores. At the 4th year of treatment, the response rates of EASI-50, EASI-75, and EASI-90 were 95%, 91%, and 76%, respectively, and the proportion of patients with PP-NRS improvement ≥3 points, ≥4 points from baseline was 79%, 71% (Figure 8); the safety profile is consistent with that reported in the published studies of dupilumab [5].
Figure 8: 204 weeks of treatment, improvement of skin lesions and itching
Long-term treatment to maintain disease control and treatment satisfaction: The 30- to 36-month RELIEVE-AD study evaluated dupril The disease control and treatment satisfaction of Uzumumab in the treatment of adults with moderate-to-severe AD was also presented at this AAD annual meeting [6]. The disease control was assessed by the ADCT scale, and it was found that the disease could be significantly controlled in the first month and continued to the 30th to 36th months (Figure 9). months further decreased (Fig. 10) [6]. In terms of treatment satisfaction, compared with baseline, the number of patients who were very satisfied with AD treatment increased significantly in the first month, and further increased in the 30th to 36th months (Figure 11) [6].
Figure 9: 30~36 months of treatment, disease control status
Figure 10: Improvement of ADCT score after 30-36 months of treatment
Figure 11: Overall satisfaction of patients after 30-36 months of treatment
Asian population also demonstrated long-term efficacy: A Japanese study found that 1 year of dupilimumab treatment was associated with an The IGA, EASI, and pruritus scores were all improved compared with the baseline. The response rates of EASI-50, EASI-75, and EASI-90 were 96%, 90.5%, and 61.1%, respectively. The PP-NRS improved by ≥3 points and ≥4 points compared with the baseline. The proportions were 92.5% and 81.8% respectively (Figure 12) [7].
Figure 12: Improvement of skin lesions and itching after 12 months of treatment
Dosing regimen adjustment can maintain long-term efficacy: A study has evaluated dupilimumab in adults with moderate-to-severe AD , the maintenance of long-term efficacy after the dosing regimen was switched from 300mg qw* to 300mg q2w [8]. The study found that steady improvement in symptoms and signs was maintained at the switch point and 48 weeks after the switch, showing durable efficacy (Figure 13) [8]. Among patients who achieved disease control at the time of switching, the majority of patients maintained disease control for 24 weeks after switching from 300 mg qw to 300 mg q2w without rebound or worsening (Figure 14) [8].
*: The approved dosage for adults with moderate-to-severe AD in China is: an initial dose of 600 mg (300 mg injected twice), followed by 300 mg every two weeks. For actual use, please refer to the instruction manual of dupilumab in China, which is for academic exchange only.
Figure 13: Control of symptoms and signs 48 weeks before and after adjusting the dosage regimen
Figure 14: Maintenance of disease control 24 weeks after dosing regimen adjustment
Facilitating the long-term treatment of AD in children*: Data from the PEDISTAD study show that children with moderate to severe AD have a multidimensional disease burden characterized by early AD onset, pruritus, sleep disturbance, and impaired quality of life, suggesting that The impact of AD on children is very serious [9]. Moderate-to-severe AD in children also affects the patient’s family’s expenditure, fatigue, sleep, quality of life, etc., and this effect increases with the severity of the disease [10]. The data from the PEDISTAD study presented at this AAD annual meeting showed that the EASI, PP-NRS, POEM, and CDLQI scores of children with moderate-to-severe AD who received dupilumab for 1 year were significantly improved compared with those before treatment*[11] .
*: Indications for children under 6 years old have not been approved in China, this is for academic exchange only.
In summary, the latest research data at this AAD annual meeting confirmed that dupilimumab can achieve comprehensive benefits in the treatment of AD, and can maintain long-term disease remission. So, how does dupilumab actually work in the real world? What about the study data for other indications for which dupilumab is still in development? Please look forward to the next sharing of “Medical Skin Channel”!
*: Dupilumab is currently only approved in China for moderate-to-severe AD indications in children and adults aged 6 years and above who are poorly controlled or not recommended for external use.
References:
[1] Robert Bissonnette, et al. AAD 2022. #P33557.
[2] Joseph F. Merola, et al. AAD 2022. #P33558.
[3] Amy S. Paller, et al. AAD 2022. #P34297.
[4] Dimittri Delevry, et al. AAD 2022. #P33325.
[5] Jacob P. Thyssen, et al. AAD 2022. #P34358.
[6] Bruce Strober, et al. AAD 2022. #P33120.
[7] Hiroyuki Fujita, et al. AAD 2022. #P32501.
[8] Lisa A. Beck, et al. AAD 2022. #P34385.
[9] Amy S. Paller, et al. AAD 2022. #P33548.
[10] Marjolein de Bruin-Weller, et al. AAD 2022. #P34021.
[11] Eulalia Baselga, et al. AAD 2022. #P33553.
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