Skip to main content
. 2022 Dec 6;11(23):7240. doi: 10.3390/jcm11237240

Table 5.

Results of clinical studies evaluating new treatment approaches for HS (only completed studies with reported study results).

References Study Design(Level of Evidence, Oxford Criteria [84]) Treatment Regimen Efficacy Data/Results
IL-17 (Secukinumab)
Prussick et al., 2019 [151] open-label pilot study
(n = 9)
evidence level: 4)		 secukinumab 300 mg weekly for 5 weeks (loading dose) followed by 300 mg every 4 weeks for 24 weeks
  • -

    HiSCR achieved in 78% after 24 weeks

  • -

    improvement of Sartorius score and DLQI
Casseres et al., 2020 [152] open-label study (n = 20)
(evidence level: 4)		 secukinumab 300 mg weekly for 5 weeks (loading dose) followed by 300 mg every 2 or 4 weeks
  • -

    pooled HiSCR rate of 70% after 24 weeks

  • -

    clinical responses were also observed in patients with failure to prior anti-TNF⍺ treatment
Reguiaï et al., 2020 [183] retrospective study
(n = 20)
(evidence level: 4)		 secukinumab 300 mg weekly for 5 weeks (loading dose) followed by 300 mg every 4 weeks
  • -

    HiSCR achieved in 75% after 16 weeks

  • -

    maintained clinical responses during follow-up

  • -

    2 patients developed Crohn disease after 3 and 5 months of treatment
Ribero et al., 2021 [184] retrospective multicenter study (n = 31)
(evidence level: 4)		 secukinumab 300 mg weekly for 5 weeks (loading dose) followed by 300 mg every 4 weeks
  • -

    HiSCR achieved in 41% after 28 weeks
Kimball et al., 2022 [153] 2 phase III randomized placebo-controlled trials (n = 1084)
  • -

    secukinumab 300 mg every 2 weeks (Q2W)

  • -

    secukinumab 300 mg every 4 weeks (Q4W)

  • -

    placebo
  • -

    HiSCR rates at week 16:

    SUNSHINE: 45.0% (Q2W); 41.8% (QW4); 33.7% (placebo)

    SUNRISE: 42.3% (Q2W); 46.1% (Q4W); 31.2% (placebo)

  • -

    superiority of secukinumab over placebo in moderate-to-severe HS

  • -

    rapid clinical responses (observed from week 2)

  • -

    acceptable safety profile
IL-17 (Bimekizumab)
Glatt et al., 2021 [34] phase II randomized placebo- and active-comparator-controlled trial (n = 90)
(evidence level: 1b)
  • -

    bimekizumab 640 mg at week 0 followed by 320 mg every 2 weeks

  • -

    adalimumab 160 mg at week 0, 80 mg at week 2, followed by 40 mg every week

  • -

    placebo
  • -

    HiSCR was achieved in 57.3% in the bimekizumab group at week 12 (vs. 26.1% in placebo group)

  • -

    HiSCR75 rates of 46.0% in bimekizumab group at week 12 (vs. 10% in placebo group; 35% in adalimumab group)

  • -

    HiSCR90 reached in 32% of patients with bimekizumab (vs. 0% in placebo group; 15% in adalimumab group)
IL-1 (Anakinra)
Leslie et al., 2014 [163] open-label study (n = 6)
(evidence level: 4)		 anakinra 100 mg daily for 8 weeks
  • -

    clinical responses with reduction of mSS and improvement of DLQI

  • -

    rapid relapses after treatment discontinuation in the follow-up period
Tzanetakou et al., 2016 [162] phase II randomized placebo-controlled trial (n = 20)
(evidence level: 2b)
  • -

    anakinra 100 mg daily for 12 weeks

  • -

    placebo
  • -

    HiSCR achieved in 78% after 12 weeks (vs. 30% in placebo group)

  • -

    modulation of cytokine production in peripheral blood mononuclear cells

  • -

    majority of patients relapse after treatment discontinuation
IL-1 ⍺ (MABp1/Bermekimab)
Kanni et al., 2018 [168] phase II randomized placebo-controlled trial
(n = 20); patients not
eligible for anti-TNF⍺
treatment
(evidence level: 2b)
  • -

    MABp1 (bermekimab) 7.5 mg/Kg every 2 weeks for 12 weeks

  • -

    placebo
  • -

    HiSCR achieved in 60% vs. 10% (MABp1 vs. placebo) at week 12

  • -

    maintained clinical responses in 40% after 24 weeks
Kanni et al., 2021 [169] open-label extension study of NCT02643654
(n = 8 *1)
(evidence level: 4)		 MABp1 (bermekimab) 7.5 mg/Kg every 2 weeks for 12 weeks patients initially randomized to placebo achieved HiSCR in 75% after 12 weeks of MABp1 treatment
Gottlieb et al., 2020 [170] phase II open-label study (n = 42)
(evidence level: 3b)		 bermekimab 400 mg every week for 12 weeks in
  • -

    patients with failure to prior anti-TNF⍺ therapy (group A)

  • -

    patients naïve to anti-TNF⍺ therapy (group B)
  • -

    comparable HiSCR rates after 12 weeks with 63% (group A) and 61% (group B)

  • -

    bermekimab as potential treatment alternative for TNF⍺ non-responders
JAK/STAT Inhibitors
Alavi et al., 2022 [180] open-label study
(NCT03569371)
(n = 10)
(evidence level: 4)		 INCB054707 15 mg p.o. daily for 8 weeks
  • -

    HiSCR achieved in 43% at week 8

  • -

    70% experienced at least one AE (esp. upper respiratory tract infections)
Alavi et al., 2022 [180] phase II randomized
placebo-controlled trial
(NCT03607487) (n = 35)
(evidence level: 2b)
  • -

    INCB054707 in escalating dose regimens (30/60/90 mg daily) for 8 weeks

  • -

    placebo
  • -

    dose dependent clinical responses; HiSCR rates of 56%/56%/88% (30/60/90 mg group) vs. 57% (placebo)

  • -

    asymptomatic thrombocytopenia occurred in 4 patients of the 90 mg group, resolved after dose interruption
Kozera et al., 2022 [181] retrospective cohort study (n = 20)
(evidence level: 4)		 upadacitinib for 12 weeks
  • -

    15 mg p.o. daily until week 4

  • -

    at week 4: patients failing HiSCR were switched to 30 mg daily
  • -

    HiSCR rates of 75% after 4 weeks and 100% after 12 weeks

  • -

    HiSCR75 achieved in 95% after 12 weeks

*1 Patients initially randomized to placebo group.