Clinical selection criteria in new clinical trials of hidradenitis suppurativa: External validity and implications on the daily clinical practice

Montero‐Vílchez, Trinidad; Salvador‐Rodríguez, Luis; Sánchez‐Díaz, Manuel; Cuenca‐Barrales, Carlos; Martínez-López, Antonio; Arias‐Santiago, Salvador; Molina-Leyva, Alejandro

doi:10.1111/dth.14254

Cited by 7 publications

(4 citation statements)

References 35 publications

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“…Regarding disease severity, Barrea et al found that adherence to the MD negatively correlated to HS severity, evaluated by Sartoriusscore [17]. In agreement with them, we observed that the adherence to the MD is negatively associated with the IHS4 score and self-reported disease activity [29,36]. Adherence to the MD has been also associated with disease severity in psoriasis [20,34].…”

Section: Discussionsupporting

confidence: 89%

Potential Benefits of the Mediterranean Diet and Physical Activity in Patients with Hidradenitis Suppurativa: A Cross-Sectional Study in a Spanish Population

et al. 2022

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There is little scientific information regarding the potential benefits of healthy lifestyles in patients with hidradenitis suppurativa (HS). The objective of this study is to explore the potential association between an adherence to a Mediterranean diet (MD), physical activity and HS severity. A cross-sectional study that included patients with HS was conducted. Disease severity was evaluated by the International Hidradenitis Suppurativa Severity Score System (IHS4) and self-reported disease activity using a Numeric Rating Scale (NRS, 0–10). The adherence to an MD was assessed by the PREvención con DIeta MEDiterránea (PREDIMED) questionnaire and the level of physical activity by the International Physical Activity questionnaire. A total of 221 patients with HS were included in our study. The adherence to an MD was average for a Spanish population. A higher adherence to an MD was associated with lower disease activity, lower self-reported Hurley and lower IHS4. The use of extra virgin olive oil as the main culinary lipid was the dietary habit that implied a lower degree of disease activity (p < 0.05). Regarding physical activity, both the self-reported severity and IHS4 presented an inverse association with the intensity of physical activity. The adherence to an MD and the intensity of physical activity were positively associated. The Mediterranean dietary pattern may have an impact on HS. Greater adherence to an MD is related to lower HS severity and more physical activity also correlates to lower disease severity. The MD could be an appropriate dietary pattern for patients with HS due to its anti-inflammatory properties, and combining this with increased levels of physical activity could have additional benefits.

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Section: Discussionsupporting

confidence: 89%

Potential Benefits of the Mediterranean Diet and Physical Activity in Patients with Hidradenitis Suppurativa: A Cross-Sectional Study in a Spanish Population

et al. 2022

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“…There are clinical trials that observed similar effectiveness and tolerability between originator adalimumab and biosimilar adalimumab in psoriasis [20]. However, the external validity of clinical trials might be low, as they usually have straight eligibility criteria, and the tool used to assess effectiveness may not be reliable in HS [21]. For example, clinical trials are frequently conducted in naïve patients to biologic treatment, and pregnant women, elderly, and very severe patients are not allowed to be included [20].…”

Section: Discussionmentioning

confidence: 99%

Switching from Adalimumab Originator to Biosimilar: Clinical Experience in Patients with Hidradenitis Suppurativa

Montero‐Vílchez

Cuenca‐Barrales

Rodriguez-Tejero

et al. 2022

JCM

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Adalimumab is currently the only biological medicine approved by the FDA for the treatment of hidradenitis suppurativa (HS). The breakout of biosimilar drugs made them more accessible due to their impact on pharmacoeconomics. However, packaging, formulation, or excipients are unique characteristics of each drug. In that way, switching from adalimumab originator to biosimilar and between biosimilars could have implications in the clinical practice. The objective of this study is to describe our clinical experience in switching from adalimumab originator to biosimilar and switching back again. A single-center retrospective cohort study was conducted that included seventeen patients with HS treated with adalimumab originator in the maintenance phase, and that achieved Hidradenitis Suppurativa Clinical Response (HiSCR), who were switched to adalimumab biosimilar for no medical reasons. The reason for the change was to improve pharmacoeconomic efficiency, following our hospital policies on biologics. Median duration with adalimumab originator treatment before switching was 48 weeks. After switching, 41.2% of patients maintained HiSCR response without additional issues, while 58.8% (10/17) reported problems after the change. Switching from adalimumab originator to biosimilar in well-controlled patients could imply problems in efficacy and adherence. Switching back to adalimumab originator appears to solve most of the problems, but some patients can lose confidence in the drug and discontinue it. It would be worthwhile to evaluate the benefit–risk ratio individually when switching an HS patient to adalimumab biosimilar.

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“…Factors independently associated with an increase in OCP effectiveness were a shorter HS duration, worsening in relation to the menstrual cycle and being receiving a concomitant therapy. A long disease duration is related to the presence of scars and draining tunnels [ 36 ], when OCPs are less effective. It was shown that the worsening of HS with the menstrual cycle was almost independently related to the percentage of AN reduction in patients with OCP treatment.…”

Section: Discussionmentioning

confidence: 99%

The Role of Oral Contraceptive Pills in Hidradenitis Suppurativa: A Cohort Study

Montero‐Vílchez

Valenzuela-Amigo

Cuenca‐Barrales

et al. 2021

Life

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There is a need to establish the role of antiandrogens as an alternative or concomitant therapy for hidradenitis suppurativa (HS). Thus, the objectives of this study are (1) to assess the effectiveness of oral contraceptive pills (OCPs) at week 12 in HS women, and (2) to describe the clinical profile of patients receiving oral contraceptive pills (OCPs). A prospective observational study was designed. This study included 100 participants, 50 women with HS who started OCPs for the first time at our HS Clinic and 50 participants without OCP treatment. The main outcome of interest was the percentage of reduction in total abscess and inflammatory nodule (AN) count at week 12. Thirty-three women received combined OCPs and 17 non-combined OCP. HS patients with OCPs treatment were younger (31.7 vs. 40.9 years, p < 0.001), thinner (28.62 vs. 33.35 kg/m2), and have a higher number of areas affected (2.32 vs. 1.38, p = 0.02) than those without OCPs. After 12-weeks of treatment, it was observed that the percentage of AN reduction was higher in HS women receiving OCP than in patients without OCP (53.9% vs. 38.42%, p = 0.049). It was observed that OCP prescription (β = 3.79, p = 0.034) and concomitant therapy (β = 3.91, p = 0.037) were independently associated with a higher % AN when controlling for disease duration, concomitant therapy, and treatment with/without OCP (R^2 = 0.67). The factors potentially associated with the percentage AN reduction at week 12 in HS women treated with OCPs were disease duration (β = −1.327, p = 0.052), concomitant therapy (β = 11.04, p = 0.079), and HS worsening with the menstrual cycle (β = 10.55, p = 0.087). In conclusion, OCPs might be effective for improving AN count in women with HS. Women whose HS worsens in relation to the menstrual cycle and have a shorter disease may benefit more from the therapeutic effect of OCPs.

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Clinical selection criteria in new clinical trials of hidradenitis suppurativa: External validity and implications on the daily clinical practice

Cited by 7 publications

References 35 publications

Potential Benefits of the Mediterranean Diet and Physical Activity in Patients with Hidradenitis Suppurativa: A Cross-Sectional Study in a Spanish Population

Potential Benefits of the Mediterranean Diet and Physical Activity in Patients with Hidradenitis Suppurativa: A Cross-Sectional Study in a Spanish Population

Switching from Adalimumab Originator to Biosimilar: Clinical Experience in Patients with Hidradenitis Suppurativa

The Role of Oral Contraceptive Pills in Hidradenitis Suppurativa: A Cohort Study

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