Abstract
Introduction
The International Hidradenitis Suppurativa Severity Score System (IHS4) is a validated tool that measures inflammatory lesions, including draining tunnels, in hidradenitis suppurativa (HS).
Objective
To evaluate secukinumab efficacy using IHS4 in patients with moderate to severe HS.
Methods
Data from the SUNSHINE and SUNRISE trials, which assessed subcutaneous secukinumab 300 mg every 2 (SECQ2W) and 4 (SECQ4W) weeks in adults with moderate to severe HS, were analyzed. Assessments included changes from baseline in IHS4 and severity classification up to Week 52; IHS4‐55, IHS4‐75, IHS4‐90 responses (55%, 75% and 90% reduction in IHS4) and concordance between IHS4‐55 and HS clinical response (HiSCR), at Weeks 16 and 52.
Results
In total, 1084 patients (SECQ2W = 361; SECQ4W = 360; placebo = 363) were analyzed. At Week 16, SECQ2W and SECQ4W demonstrated a numerically higher reduction in IHS4 from baseline versus placebo (adjusted mean [95% CI]: −10.80 [−12.30 to −9.30] and −9.46 [−10.96 to −7.96] vs. −4.92 [−6.43 to −3.41]); the reduction was maintained until Week 52 in both dose regimens. A greater proportion of patients achieved IHS4‐55 with SECQ2W (43.4%) and SECQ4W (39.5%) versus placebo (31.5%) at Week 16, with further improvement at Week 52. Similar trends were observed for IHS4‐75 and IHS4‐90 responses. While no patients had mild disease based on IHS4 (80.7% had severe and 19.3% had moderate HS) at baseline, a greater proportion of patients were categorized as having mild disease at Week 16 in the SECQ2W (25.9%) and SECQ4W (24.0%) groups versus placebo (16.4%); this trend continued up to Week 52 in both dose regimens. Strong concordance (>85%) was observed between IHS4‐55 and HiSCR.
Conclusions
Both SECQ2W and SECQ4W demonstrated efficacy in improving treatment response as measured by IHS4 and reducing disease severity versus placebo at Week 16 and these improvements were sustained through Week 52. These findings support that the dynamic and dichotomous IHS4 can efficiently detect treatment response changes in clinical trial settings.
Clinical Trials Registration
SUNSHINE (NCT03713619); SUNRISE (NCT03713632).
Given that both dynamic IHS4 and dichotomous IHS4‐55 use validated method of quantifying lesion types including draining tunnels, these results indicate that IHS4 and IHS4‐55 can detect changes in response to treatment in clinical trial setting. DLQI, Dermatology Life Quality Index; HiSCR, hidradenitis suppurativa clinical response; HS, hidradenitis suppurativa; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg.
Why was the study undertaken?
A post hoc analysis of data from the SUNSHINE and SUNRISE trials was conducted to assess the efficacy of secukinumab using International Hidradenitis Suppurativa Severity Score System (IHS4) in patients with moderate to severe hidradenitis suppurativa (HS).
What does this study add?
Secukinumab demonstrated efficacy in improving clinical response, as measured by the IHS4 and IHS4‐55 (a 55% reduction in IHS4 from baseline), and reducing disease severity classified by IHS4, versus placebo at Week 16. These improvements were sustained until Week 52.
What are the implications of this study for disease understanding and/or clinical care?
With IHS4 using a validated technique to quantify lesion types, including draining tunnels, the findings of this analysis suggest that IHS4 and IHS4‐55 can efficiently detect treatment response changes in clinical trial settings.
INTRODUCTION
Hidradenitis suppurativa (HS) is a chronic, inflammatory, follicular skin disease characterized by recurrent and painful deep‐seated, inflammatory nodules, abscesses, draining tunnels and fibrotic scars. 1 Several validated outcome instruments have been developed for both the clinical trial setting and clinical practice to evaluate treatment response in patients with HS. 2 The most commonly used efficacy endpoint in HS clinical trials to assess treatment response is the hidradenitis suppurativa clinical response (HiSCR). 2 , 3 However, specific drawbacks, including lack of quantification of draining tunnels, have been identified with the use of the HiSCR, which may limit its applicability to evaluate novel therapies. 4
Reliable outcome measurement instruments that address these drawbacks are required to ensure appropriate disease management in patients with HS. In addition, there is a need for holistic assessment of disease severity and accurate classification to inform patient eligibility for early initiation of biologics. The Hurley staging system has traditionally been employed to categorize the severity of HS by considering the appearance and location of lesions, 5 but it was originally only designed to assist with surgical treatment decisions for HS.
The International Hidradenitis Suppurativa Severity Score System (IHS4), a validated tool designed to dynamically assess the severity of HS by assigning different weights to different lesion types, was developed by the European Hidradenitis Suppurativa Foundation. 6 The IHS4 is calculated by summing up the number of inflammatory nodules (multiplied by 1 point), number of abscesses (multiplied by 2 points) and number of draining tunnels (multiplied by 4 points) to assess the disease severity (score ≤3: mild disease, 4–10: moderate disease, ≥11: severe disease). IHS4 is currently being utilized as a secondary outcome measure in several clinical trials 7 , 8 (NCT04092452; NCT05322473). Additionally, dichotomous outcomes are frequently required for clinical research, which led to the development of IHS4‐55, based on the threshold of a 55% reduction in the IHS4 total score from baseline. 9 , 10 Comparison of HiSCR versus IHS4 outcome measures is illustrated in Figure 1.
FIGURE 1.
Comparison of HiSCR versus IHS4 outcome measures. 3 , 6 , 9 HiSCR, hidradenitis suppurativa clinical response; HS, hidradenitis suppurativa; IHS4, International Hidradenitis Suppurativa Severity Score System.
In the pivotal Phase 3 SUNSHINE and SUNRISE trials, secukinumab, an anti–interleukin (IL)‐17A therapy, improved the signs and symptoms of HS, as measured by HiSCR, in patients with moderate to severe HS at Week 16, which was sustained until Week 52 with a trend for improvement. 11 Here, a post hoc analysis of data from the SUNSHINE and SUNRISE trials was performed to assess the efficacy of secukinumab using IHS4 in patients with moderate to severe HS.
PATIENTS AND METHODS
Study design
SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) were Phase 3, randomized, placebo‐controlled, multicentre clinical trials with identical design evaluating the short‐term (up to Week 16) and long‐term (up to Week 52) efficacy and safety of two secukinumab dosing regimens (secukinumab 300 mg every 2 [SECQ2W] or every 4 [SECQ4W] weeks) in adults with moderate to severe HS. Details regarding the study design, inclusion and exclusion criteria have been published previously. 11 Briefly, patients aged ≥18 years with ≥1 year since HS diagnosis and with moderate to severe disease (defined as a total of ≥5 inflammatory lesions affecting ≥2 distinct anatomical areas) were included. Eligible patients were randomized (1:1:1) at baseline to receive SECQ2W, SECQ4W or placebo. Patients received subcutaneous injections (secukinumab 300 mg or placebo) once a week for 4 weeks (induction) at baseline, Weeks 1, 2, 3 and 4. Thereafter, patients received SECQ2W, SECQ4W or placebo, based on the treatment group they were assigned to up to Week 16. At Week 16, patients previously randomized to either SECQ2W or SECQ4W continued with the same dose regimen, whereas patients randomized to placebo were switched to receive SECQ2W or SECQ4W up to Week 52.
Endpoints and analyses
The primary and key secondary endpoints of the SUNSHINE and SUNRISE trials have been reported previously. 11 Endpoints assessed in this post hoc analysis included change in IHS4 severity score from baseline up to Week 52, proportion of patients achieving IHS4‐55, IHS4‐75 and IHS4‐90 (defined as 75% and 90% reduction in the total IHS4 score from baseline, respectively) at Week 16 and Week 52 and shift in IHS4 disease severity from baseline to Week 16 and Week 52. In addition, the concordance was assessed between IHS4‐55 response and HiSCR (defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscesses or draining tunnels) at Week 16 and Week 52, regardless of the active treatment assignment. Concordance between IHS4‐55 and HiSCR was estimated as the proportion of patients whose responses were in agreement at a given visit within the secukinumab or placebo groups. Similarly, concordance between IHS4‐55 and Dermatology Life Quality Index (DLQI) response (a decrease of ≥5 points on DLQI total score from baseline) and HiSCR and DLQI response were also estimated at Weeks 16 and 52 in patients with baseline DLQI ≥5.
Statistical analyses
All analyses were conducted on pooled as well as individual trial data from the SUNSHINE and SUNRISE trials and based on observed data from the full analysis set, which consisted of all patients who were randomly assigned to study treatment. Adjusted means and 95% confidence intervals (CI) for change in IHS4 score from baseline were estimated using mixed effects repeated measures models (MMRM), which included treatment, baseline IHS4 score, visit, treatment‐by‐visit interaction and trial as covariates with unstructured covariance matrix. MMRM analyses for change in IHS4 score from the baseline up to Week 16 were performed for SECQ2W, SECQ4W and placebo groups, while the analyses for up to Week 52 were performed for SECQ2W and SECQ4W treatment groups. The MMRM analyses were performed using SAS 9.4 (SAS Institute, Cary, NC). For patients who switched from placebo to secukinumab at Week 16, absolute mean (standard error [SE]) change from baseline from Week 16 till Week 52 are presented. No statistical hypotheses tests were performed. For the concordance, the following cut‐off points were adopted: negligible concordance (0%–9%); weak concordance (10%–39%); moderate concordance (40%–69%); strong concordance (70%–89%); and very strong concordance (90%–100%).
RESULTS
Patients
In this analysis, 541 patients from the SUNSHINE trial (SECQ2W, N = 181; SECQ4W, N = 180; placebo, N = 180) and 543 from the SUNRISE trial (SECQ2W, N = 180; SECQ4W, N = 180; placebo, N = 183) were included. In total, 1084 patients enrolled in both trials were included in the pooled dataset (SECQ2W, N = 361; SECQ4W, N = 360; placebo, N = 363).
The mean ± SD IHS4 at baseline in the SECQ2W, SECQ4W and placebo treatment groups was 27.3 ± 19.7, 25.0 ± 20.2 and 25.2 ± 18.9 in the SUNSHINE trial, 29.6 ± 22.8, 26.1 ± 19.1 and 26.5 ± 20.7 in the SUNRISE trial and 28.5 ± 21.3, 25.6 ± 19.7 and 25.8 ± 19.8 in the pooled dataset, respectively. Based on the IHS4 severity classification, 78.6% of patients (425 of 541) in the SUNSHINE trial, 82.7% (449 of 543) in the SUNRISE trial and 80.6% (874 of 1084) in the pooled dataset were categorized as having severe HS at baseline and 21.4% (116 of 541) of patients in SUNSHINE trial, 17.3% (94 of 543) in SUNRISE trial and 19.4% (210 of 1084) in the pooled dataset as having moderate HS at baseline (Tables S1 and S2). None of the patients had mild HS at baseline.
In SUNSHINE, SUNRISE and the pooled datasets, a greater proportion of patients with severe HS had prior exposure to biologics than those with moderate HS. Among patients categorized as moderate disease, based on the IHS4 severity classification, 45% (18 of 40) had Hurley Stage I, 25.4% (162 of 639) had Hurley Stage II and 7.4% (30 of 405) had Hurley Stage III. Among patients with severe disease, 55% (22 of 40) had Hurley Stage I, 74.6% (477 of 639) had Hurley Stage II and 92.6% (375 of 405) had Hurley Stage III. Further, among patients who were classified as having severe disease using IHS4 severity classification, 62.7% were classified as having severe or very severe disease, 37.2% were classified as having moderate disease and 0.1% was classified as having mild disease based on Hidradenitis Suppurativa Physician's Global Assessment scale (HS‐PGA). 12
Change of IHS4 from baseline up to Week 52
The treatment with SECQ2W and SECQ4W resulted in a greater reduction (i.e. improvement) in IHS4 compared to placebo at all time points evaluated up to Week 16. In SUNSHINE, SUNRISE and the pooled dataset, the adjusted mean reduction (95% CI) was numerically higher with SECQ2W and SECQ4W as compared to placebo at Week 16: −10.49 (−12.51 to −8.48) and −9.07 (−11.09 to −7.06) versus −4.42 (−6.45 to −2.39) in the SUNSHINE trial, −11.04 (−13.28 to −8.80) and −9.87 (−12.11 to −7.63) versus −5.35 (−7.61 to −3.10) in SUNRISE trial and −10.80 (−12.30 to −9.30) and −9.46 (−10.96 to −7.96) versus −4.92 (−6.43 to −3.41) in pooled dataset, respectively. Consistent with the HiSCR response over time, 11 the reduction from baseline with SECQ2W and SECQ4W at Week 16 was maintained through Week 52 with a trend for improvement over time (Figure 2). A similar effect was observed among patients in the placebo group who were switched to one of the secukinumab dose regimens at Week 16. There was a rapid reduction in the IHS4 as early as 2 weeks after switching from placebo to secukinumab treatment (i.e. Week 18), with the reduction being sustained up to Week 52.
FIGURE 2.
Change from baseline in IHS4 up to Week 52: (a) SUNSHINE trial; (b) SUNRISE trial; and (c) pooled data. CI, confidence interval; IHS4, International Hidradenitis Suppurativa Severity Score System; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg. The error bars represent standard error. All data are reported as observed. Data from baseline to week 16 are based on mixed effects repeated measures models, with treatment, baseline IHS4, visit, treatment‐by‐visit interaction, and trial were used to estimate the adjusted means and to infer 95% CIs. Data from week 18 to 52 (in grey box) are reported as mean change.
IHS4‐55, IHS4‐75 and IHS4‐90 responses at Week 16 and Week 52
In SUNSHINE, SUNRISE and pooled datasets, a numerically greater proportion of patients in the SECQ2W and SECQ4W treatment groups achieved IHS4‐55 responses at Week 16 compared to placebo. A similar trend was observed for the IHS4‐75 and IHS4‐90 responses (Figure 3). The IHS4‐55, IHS4‐75 and IHS4‐90 responses observed at Week 16 showed a trend towards further improvement at Week 52 in patients receiving secukinumab treatment. In patients who switched from placebo to SECQ2W or SECQ4W at Week 16, IHS4‐55, IHS4‐75 and IHS4‐90 responses increased up to Week 52, following the switch, at a level similar to those receiving continuous secukinumab treatment.
FIGURE 3.
Proportion of patients achieving IHS4‐55, IHS4‐75 and IHS4‐90 at Weeks 16 and 52: (a) SUNSHINE trial (b) SUNRISE trial; and (c) pooled data. IHS4, International Hidradenitis Suppurativa Severity Score System; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg. The IHS4‐55, IHS4‐75, and IHS4‐90 indicate 55%, 75%, and 90% reduction in the IHS4 from the baseline, respectively. All data are reported as observed.
Shift in the IHS4 severity classification grade from baseline to Week 16 and Week 52
With the majority of patients (>79% in SUNSHINE, SUNRISE and pooled datasets) classified as having severe disease and no patients classified as having mild disease based on IHS4 severity classification at baseline, a greater proportion of patients were reported to have mild disease in the secukinumab groups compared to placebo at Week 16. Compared to Week 16, at Week 52, approximately 30% of patients who were receiving secukinumab treatment were reported to have mild disease. Similarly, in patients who were reassigned from placebo to secukinumab at Week 16, approximately 30% were reported having a mild disease at Week 52, after having switched from placebo to secukinumab from Week 16 onwards, compared to approximately 15% at Week 16 (Figure 4).
FIGURE 4.
Shift in the IHS4 severity classification grade from baseline to Week 16 and Week 52: (a) SUNSHINE trial; (b) SUNRISE trial; and (c) pooled data. IHS4, International Hidradenitis Suppurativa Severity Score System; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab 300 mg. IHS4 disease severity: mild: ≤3, moderate: 4–10, severe: ≥11. All data are reported as observed.
Concordance between IHS4‐55 and HiSCR, IHS4‐55 and DLQI response and HiSCR and DLQI response
In all the datasets (SUNSHINE, SUNRISE and pooled), there was a strong concordance between IHS4‐55 and HiSCR responses at Week 16 (86.2%–88.5%) and at Week 52 (85.7%–88.3%) in all treatment groups. A moderate concordance between IHS4‐55 and DLQI responses was observed at Week 16 (57.1%–66.2%) and at Week 52 (58.9%–64.3%), which was similar to that observed between HiSCR and DLQI responses (Week 16: 58.2%–71.4% and Week 52: 54.6%–69.4%) (Table 1).
TABLE 1.
Concordance between IHS4‐55 and HiSCR responses, IHS4‐55 and DLQI responses and HiSCR and DLQI responses.
| Concordance | Any SEC | PBO | PBO‐any SEC | |
|---|---|---|---|---|
| Week 16 | Week 52 | Week 16 | Week 52 | |
| SUNSHINE | ||||
| IHS4‐55 and HiSCR | 87.5 (N = 361) | 85.7 (N = 361) | 87.6 (N = 180) | 86.0 (N = 180) |
| IHS4‐55 and DLQI | 57.1 (N = 290) | 58.9 (N = 290) | 65.9 (N = 145) | 64.3 (N = 145) |
| HiSCR and DLQI | 58.2 (N = 290) | 54.6 (N = 290) | 71.4 (N = 145) | 69.4 (N = 145) |
| SUNRISE | ||||
| IHS4‐55 and HiSCR | 86.2 (N = 360) | 88.3 (N = 360) | 88.5 (N = 183) | 87.6 (N = 183) |
| IHS4‐55 and DLQI | 60.3 (N = 304) | 62.4 (N = 304) | 66.2 (N = 166) | 60.0 (N = 166) |
| HiSCR and DLQI | 63.8 (N = 304) | 62.9 (N = 304) | 70.4 (N = 166) | 58.2 (N = 166) |
| Pooled | ||||
| IHS4‐55 and HiSCR | 86.8 (N = 721) | 87.0 (N = 721) | 88.1 (N = 363) | 86.8 (N = 363) |
| IHS4‐55 and DLQI | 58.7 (N = 594) | 60.8 (N = 594) | 66.0 (N = 311) | 62.0 (N = 311) |
| HiSCR and DLQI | 61.1 (N = 594) | 59.0 (N = 594) | 70.9 (N = 311) | 63.5 (N = 311) |
Note: The IHS4‐55 is a dichotomous outcome based on a 55% reduction in the total IHS4 score. Concordance with DLQI is estimated in patients with baseline DLQI ≥ 5. All data are reported as observed.
Abbreviations: DLQI, dermatology life quality index; HiSCR, hidradenitis suppurativa clinical response; IHS4, International hidradenitis suppurativa severity scoring system; PBO, placebo; Q2W, every 2 weeks; Q4W, every 4 weeks; SEC, secukinumab.
DISCUSSION
In this post hoc analysis, the efficacy of secukinumab as measured by dynamic and dichotomous IHS4 was evaluated in patients with moderate to severe HS, based on the data from SUNSHINE and SUNRISE pivotal Phase 3 trials. 11 Secukinumab demonstrated a greater improvement in IHS4 compared to placebo from as early as Week 2 through to Week 16. Additionally, the clinical response with secukinumab was sustained through Week 52, with a trend for improvements observed after Week 16. The results from the analysis of data at individual study level were consistent with the pooled data analysis.
IHS4 takes into account the severity of lesions, that is, inflammatory nodules, abscesses and draining tunnels, in a validated and dynamic manner. The IHS4 assigns points to inflammatory nodules, abscesses and draining tunnels based on their impact on patients' quality of life, with draining tunnels given the most weight (4 points). 6 This weighting reflects the fact that draining tunnels are often the most chronically inflamed draining lesions and are typically more impactful on quality of life than nodules and abscesses. This was also observed in a real‐world study that reported a greater impact on quality of life, including more severe pain, worse mental health and reduced work productivity in patients with draining tunnels compared to those without draining tunnels. 13 Improvements in the IHS4 reflect improvements in these chronically inflamed and draining lesions. In contrast, the HiSCR system counts nodules and abscesses with equal weight and does not provide specific evaluation of draining tunnels, which could make HiSCR less sensitive to detect improvement to draining tunnels in response to treatment. 3 In a Phase II trial assessing the efficacy of different dosages of vilobelimab, an anti‐C5a monoclonal antibody, in patients with moderate to severe HS, the HiSCR rate was not statistically different between the placebo and vilobelimab‐treated groups and the trial did not meet its primary endpoint (NCT03487276; unpublished data). 14 , 15 However, additional analyses using IHS4 demonstrated a significant reduction in draining tunnels after treatment, showing that high‐dose vilobelimab treatment was significantly different from placebo, highlighting the need for an endpoint that dynamically incorporates draining tunnels (NCT03487276; unpublished data). 14 , 15 This suggests that an endpoint incorporating draining tunnels, such as the IHS4, might show different results if used in a trial testing a therapy with a differential effect on draining tunnels. It is important to note that therapies may perform differently on HiSCR and IHS4, as these measures evaluate different clinical outcomes.
In this post hoc analysis, the response to secukinumab treatment as evaluated by IHS4‐55 was consistent with the findings using HiSCR. 11 These findings were similar to those observed in the phase 3 PIONEER trials, with the performance of IHS4‐55 in PIONEER 1 and 2 studies being shown to be comparable to HiSCR. 9 Additionally, the placebo response observed with IHS4 in this analysis was consistent with the results observed in a post hoc analysis of PIONEER 1 and 2 studies. Of note, a progressive reduction in severity of inflammatory lesions with secukinumab treatment was also observed with higher threshold outcomes, such as IHS4‐75 and IHS4‐90 in this analysis. Also, a strong concordance between IHS4‐55 and HiSCR was observed. Although, IHS4‐55 has been previously validated, the concordance between dichotomous outcomes such as IHS4‐55 or HiSCR and patient‐reported outcomes has not yet been explored. In this analysis, the concordance between IHS4‐55 and DLQI responses was moderate, which was similar to that observed between HiSCR and DLQI responses.
The baseline clinical characteristics data showed a difference between IHS4 severity classification (mild, moderate and severe) and Hurley staging, particularly in patients classified as having Hurley Stage I. These data and a recent publication suggest that IHS4, which numerically and parametrically assesses all HS lesions, is better at categorizing HS disease severity, especially the current activity, than Hurley staging. 16
Patients with IHS4 moderate or severe disease at baseline showed improvement in disease severity following treatment with secukinumab, with a larger proportion of patients classified as having mild disease as compared to placebo at Week 16; improvements were sustained until Week 52 in both secukinumab dose groups. Nearly one‐third of patients who switched from placebo to secukinumab at Week 16 were considered to have mild disease by Week 52, a proportion similar to those who received continuous secukinumab treatment. Of note, the analysis has inherent limitations of a post hoc analysis and the same limitations of SUNSHINE and SUNRISE trials, including a lack of an active comparator. 11
CONCLUSIONS
In this post hoc analysis of SUNSHINE and SUNRISE trials, both the Q2W and Q4W dose regimens of secukinumab showed efficacy in improving clinical response, as measured by IHS4‐55 and changes in IHS4 severity classification compared to placebo at Week 16, with improvements sustained until Week 52 in patients with moderate to severe HS. The IHS4‐55 had a strong concordance rate with HiSCR, while showing a moderate concordance with DLQI. Given that both dynamic IHS4 and dichotomous IHS4‐55 use validated method of quantifying lesion types including draining tunnels, these results indicate that IHS4 and IHS4‐55 can detect changes in response to treatment in clinical trial setting.
FUNDING INFORMATION
This investigation was sponsored by Novartis Pharma AG, Basel, Switzerland.
CONFLICT OF INTEREST STATEMENT
Christos C. Zouboulis reports consultancy/advisory board/lecture fee disease‐relevant honoraria from Almirall, Boehringer Ingelheim, Eli Lilly, Idorsia, Incyte, InflaRx, Novartis, Sanofi and UCB. He is the president of the EHSF e.V., coordinator of the ALLOCATE Skin group of the ERN Skin and chair of the ARHS Task Force group of the EADV. He is the editor of the EADV News and the copyright co‐holder of IHS4 on behalf of the EHSF e.V. His employer has received disease‐relevant clinical study fees from Boehringer Ingelheim, InflaRx, Novartis and UCB for his participation as clinical investigator. Athanassios Kyrgidis declares no conflict of interest. Afsaneh Alavi reports consultancy fees from AbbVie, Boehringer Ingelheim, Incyte, InflaRx Novartis and UCB; she is a principal investigator for Boehringer Ingelheim and Process and serves on the board of EHSF. Gregor B. E. Jemec reports consultancy fees from Novartis and UCB, has received grants from Abbvie, Chemocentryx, LEO, InflaRx, Novartis and UCB and support for attending meetings from Sanofi. He is the vice president of the EHSF e.V. and in the board of C3 and CHORD and is co‐coordinator of the ALLOCATE Skin group of the ERN Skin and vice chair of the ARHS Task Force group of the EADV. He is editor‐in‐chief of dermatology. Antonio Martorell has acted as a consultant, advisory board member and investigator and received honoraria from Novartis, AbbVie, Janssen Cilag, UCB, Lilly, LEO Pharma, L'Oreal, Sanofi, Sandoz, Boehringer Ingelheim and Amgen. Angelo V. Marzano reports consultancy/advisory boards' disease‐relevant honoraria from AbbVie, Boehringer‐Ingelheim, Novartis, Pfizer, Sanofi and UCB. Hessel H. van der Zee reports personal fees from AbbVie, InflaRx, Novartis, Galderma and Incyte. Magdalena B. Wozniak, Angela Llobet Martinez, Torben Kasparek, Teresa Bachhuber, Christine‐Elke Ortmann, Nicolas Thomas and Shoba Ravichandran are employees of Novartis. Iryna Lobach was an employee of Novartis at the time of the study. Thrasyvoulos Tzellos reports consultancy/advisory boards/speaker fees from AbbVie, Novartis, Boehringer‐Ingelheim and UCB. He is the treasurer of the EHSF e.V.
ETHICAL APPROVAL
The study protocol and all amendments were reviewed by the Independent Ethics Committee or Institutional Review Board for each centre.
ETHICS STATEMENT
Written informed consent was obtained from each participating patient.
Supporting information
Data S1:
ACKNOWLEDGEMENTS
The authors thank Ramji Narayanan (Novartis Pharmaceuticals UK Ltd., London, UK), Nihal Maremanda (Novartis Healthcare Pvt. Ltd., Hyderabad, India), and Trudy McGarry (Novartis Ireland Ltd., Dublin, Ireland) for medical writing and editorial support, which was funded by Novartis Pharma AG, Basel, Switzerland, in accordance with the Good Publication Practice (GPP 2022) guidelines (https://www.ismpp.org/gpp‐2022). The Departments of Dermatology, Venereology, Allergology and Immunology, Staedtisches Klinikum Dessau, Dessau, Germany and the Department of Dermatology, Zealand University Hospital, Roskilde Denmark are health care providers of the European Reference Network for Rare and Complex Skin Diseases (ERN Skin‐ALLOCATE Skin group). The authors would like to thank the patients who participated in the trials and the study team supporting the HS development plan.
Zouboulis CC, Kyrgidis A, Alavi A, Jemec GBE, Martorell A, Marzano AV, et al. Secukinumab efficacy in patients with hidradenitis suppurativa assessed by the International Hidradenitis Suppurativa Severity Score System (IHS4): A post hoc analysis of the SUNSHINE and SUNRISE trials. J Eur Acad Dermatol Venereol. 2025;39:1421–1430. 10.1111/jdv.20369
DATA AVAILABILITY STATEMENT
The authors and Novartis are committed to sharing, with qualified external researchers, access to patient‐level data and supporting clinical documents from eligible trials. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trials in line with applicable laws and regulations.
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Data Availability Statement
The authors and Novartis are committed to sharing, with qualified external researchers, access to patient‐level data and supporting clinical documents from eligible trials. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymized to respect the privacy of patients who have participated in the trials in line with applicable laws and regulations.