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American Diabetes Association

Conference summaries


Psoriatic arthritis

24-week results from a multicentre, randomised study evaluating ixekizumab versus adalimumab in psoriatic arthritis patients with psoriasis of ≥10% or <10% body surface area involvement at baseline

Presented by: Prof. Saxon Smith Dermatology Centre, Hospital CUF Descobertas, Lisbon, Portugal
  • In bDMARD-naïve patients with PsA and concomitant PsO, ixekizumab was associated with greater response than adalimumab on skin and joint outcomes, independently of baseline body surface area.

The selective interleukin-17A inhibitor ixekizumab (IXE) is approved for the treatment of active psoriatic arthritis (PsA) and moderate-to-severe plaque psoriasis (PsO). The SPIRIT-H2H study evaluated the efficacy and safety of IXE versus adalimumab (ADA), another biologic disease-modifying antirheumatic drug (bDMARD), approved in patients with PsA and PsO. [1]

  • This post-hoc subgroup analysis evaluated various 24-week efficacy outcomes from SPIRIT-H2H in patients with high or low PsO body surface area (BSA) involvement at baseline.

Type of study, patients, and inclusion criteria

  • SPIRIT-H2H was a multicentre, open-label, rater-blinded, parallel-group study in which bDMARD-naïve patients (N=566) with PsA and active PsO (≥3% BSA involvement) were randomised to IXE or ADA for 52 weeks.
  • Dosing was based on the baseline severity of PsO:
    • Moderate-to-severe PsO was defined as PASI score ≥12, sPGA ≥3 and BSA involvement ≥10%.
    • Patients with moderate-to-severe PsO received:
      • IXE (160 mg at week 0, 80 mg Q2W up to week 12 then Q4W). or
      • ADA (80 mg at week 0, 40 mg Q2W starting at week 1).
  • Patients not fulfilling the criteria for moderate-to-severe PsO received:
    • IXE (160 mg at week 0, 80 mg Q4W), or
    • ADA (40 mg at week 0, 40 mg Q2W),

Primary outcome measure

  • The primary endpoint was the proportion of patients achieving simultaneous improvement of ≥50% in American College of Rheumatology criteria (ACR50) and 100% in PASI score (PASI100) at week 24.
  • In this post-hoc subgroup analysis, efficacy outcomes at week 24 were compared between IXE and ADA in patients with baseline BSA involvement of ≥10% or <10%.
  • At baseline, patients with BSA ≥10% (n=217) consistently showed higher arthritis- and skin-related clinical assessment scores, and worse patient-reported outcomes, than patients with BSA <10% (n=349).
  • With regards to the simultaneous achievement of ACR50 and PASI100 at week 24, consistent response rates across baseline BSA levels were observed among IXE-treated patients (37.2%, and 35.3% for high and low BSA, respectively) (Figure).
  • Among ADA-treated patients, a lower response rate was observed in the high compared to the low BSA subgroup (21.2% vs 31.8%), resulting in a significant difference versus IXE.
  • PASI100 and PASI90 responses were significantly higher for IXE than ADA in both subgroups.
  • By contrast, PASI75 responses were significantly higher for IXE only in the subgroup with BSA <10%.
  • For ACR50, responses were similar for IXE versus ADA in both subgroups. Remission rates based on Disease Activity in Psoriatic Arthritis scores and Minimal Disease Activity (MDA6) were significantly higher for IXE than ADA in the BSA ≥10% subgroup.
  • Dermatology Life Quality Index (0,1) responses were also significantly higher for IXE than ADA in the BSA ≥10% subgroup.
  • IXE was associated with higher levels of response than ADA for skin and joint outcomes in bDMARD-naïve patients with active PsA and concomitant PsO, regardless of BSA involvement at baseline.
  • For patients with ≥10% BSA involvement, IXE was associated with a statistically significant better efficacy outcome than ADA with respect to the primary endpoint.
  • Data from this post-hoc analysis are consistent with the findings of the SPIRIT-H2H study.

Key messages/Clinical perspectives

  • In bDMARD-naïve patients with PsA and concomitant PsO, IXE was associated with higher levels of response than ADA on skin and joint outcomes, irrespective of baseline BSA involvement.


References

References


  1. Mease PJ, Smolen JS, Behrens F, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2019 Sep 28. pii: annrheumdis-2019-215386.

Presenter disclosure information: S Smith: AbbVie, BMS, Eli Lilly and Company, Janssen-Cilag, Leo Pharma, and Novartis, Sanofi Genzyme.

Medical writer: Patrick Moore, PhD

Reviewer: Martina Lambertini, MD

Local reviewers: Martina Lambertini, MD (Italian); Alain Brassard, MD (French); Jorge Moreno González, MD (Spanish); Swen Malte John, MD, PhD (German); Marcelo Arnone, MD (Portuguese)

Scientific Editor: Prof. Brigitte Dréno, MD


CLINICAL TRIALS

PSORIASIS

Efficacy and safety of ixekizumab in a phase 3, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis

Presented by: Prof. Kim A. Papp, Department of Medicine, Division of Dermatology, University of Toronto, Toronto, Canada

ATOPIC DERMATITIS

Efficacy and safety of baricitinib in combination with topical corticosteroids in moderate to severe atopic dermatitis: results of a phase 3 randomized, double-blind, placebo-controlled 16-week trial (BREEZE-AD7)

Presented by: Prof. Kristian Reich, Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation® Center, Hamburg, Germany

PRURIGO NODULARIS

Phase 2b study of nemolizumab in patients with moderate to severe prurigo nodularis and associated severe pruritus

Presented by: Prof. Sonja Ständer, Department of Dermatology and Center for Chronic Pruritus (KCP), University Hospital Münster, Germany

VITILIGO

Efficacy and safety of a 52-week, randomized, double-blind trial of ruxolitinib cream for the treatment of vitiligo

Presented by: Dr. Amit G. Pandya, University of Texas Southwestern Medical Center, Dallas, TX, USA
 

EMERGING TERAPIES

PSORIASIS

Emerging therapies for psoriasis

Presented by: Prof. Michel Gilliet, Department of Dermatology, Lausanne CHUV, Switzerland

ATOPIC DERMATITIS

New and emerging therapies in atopic dermatitis

Presented by: Prof. Dagmar Simon, Department of Dermatology, Inselspital, Bern University Hospital, Bern, Switzerland

ONYCHOMYCOSIS

Emerging treatments for onychomycosis

Presented by: Dr. Ditte Marie L. Saunte, Department of Dermatology, Institute for Clinical Medicine, Zealand University Hospital, Roskilde, Denmark
 

REVIEW & UPDATES

ACNE & ROSACEA

Isotretinoin for acne and rosacea

Presented by: Dr. Pedro Mendes-Bastos, Dermatology Centre, Hospital CUF Descobertas, Lisbon, Portugal

ALOPECIA AREATA

New drugs for alopecia areata

Presented by: Prof. Spyridon Gkalpakiotis, Department of Dermatovenereology, Third Faculty of Medicine and University Hospital of Kralovske Vinohrady, Prague, Czech Republic.

DERMATOSURGERY

Update in dermatosurgery

Presented by: Prof. Eduardo Nagore, Department of Dermatology, Instituto Valenciano de Oncología, Valencia, Spain

EPIDERMOLYSIS BULLOSA

New start of gene therapy in epidermolysis bullosa

Presented by: Prof. Leena K. Bruckner-Tuderman, University Medical Center, Albert-Ludwigs-University of Freiburg, Germany

MELANOMA

Treatment resistance in metastatic melanoma

Presented by: Prof. Martin Röcken, Department of Dermatology, Eberhard-Karls-University Tübingen, Germany

SCAR TREATMENT

Future of medical scar treatment

Presented by: Prof. Gabriella Fabbrocini, Department of Dermatology, University of Naples Federico II, Naples, Italy
 

EDUCATION FORUM

NON-MELANOMA SKIN CANCER

Systemic treatments of non-melanoma skin cancer

Presented by: Prof. Henrik F. Lorentzen, Department of Dermatology, Aarhus University Hospital, Denmark
 

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