1040: Impact of Weight and Sex on Long-term Persistence to Secukinumab Treatment in Patients with Active Psoriatic Arthritis or Ankylosing Spondylitis

Uta Kiltz¹, Petros P. Sfikakis², Nicola Gullick³, ATHINA THEODORIDOU⁴, Anna Kandyli⁵, Jan Brandt-Juergens⁶, Philippe Goupille⁷, Nicola Maiden⁸, Karl Gaffney⁹, Daniel Peterlik¹⁰, Barbara Schulz¹¹, Effie Pournara¹¹ and Piotr Jagiello¹¹, ¹Rheumazentrum Ruhrgebiet, Herne, Germany, ²Joint Academic Rheumatology Program, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece, ³University Hospital Coventry & Warwickshire; Warwick Medical School, University of Warwick, Coventry, United Kingdom, ⁴Euromedica Geniki Kliniki, General Hospital, Thessaloniki, Greece, ⁵Rheumatology Outpatient Clinic, Iaso General Hospital, Athens, Greece, ⁶Rheumatologische Schwerpunktpraxis, Berlin, Germany, ⁷Rheumatology department, University Hospital of Tours, Tours, France, ⁸Craigavon Area Hospital, Southern Health & Social Care Trust, Craigavon, United Kingdom, ⁹Norfolk and Norwich University Hospital NHS Trust, Norfolk, United Kingdom, ¹⁰Novartis Pharma GmbH, Nürnberg, Germany, ¹¹Novartis Pharma AG, Basel, Switzerland

Background/Purpose: Secukinumab (SEC) has demonstrated a high sustained response rate in patients (pts) with psoriatic arthritis (PsA) or ankylosing spondylitis (AS) across Phase III clinical trials.^1-3 SERENA is an ongoing longitudinal, non-interventional study conducted across 438 sites in Europe collecting real-world data from pts with moderate to severe psoriasis, PsA or AS. Here we report the impact of weight and sex on SEC treatment persistence and treatment safety in pts with active PsA or AS from the SERENA study.

Methods: The current interim analysis included data of 524 pts with PsA (290 females and 234 males) and 473 pts with AS (185 females and 288 males) followed up for at least 3 years. Adult pts with active PsA or AS were required to have received at least 16 weeks of SEC treatment before enrolment in the study. Based on weight, pts were categorized into two groups (< 90/≥90 kg). The impact of weight and sex (female/male) on treatment persistence was assessed using descriptive statistics.

Results: Out of 524 pts with PsA and 473 pts with AS, 333 (63.5%) and 323 (68.3%) pts remained in the study respectively. Subgroup analysis by sex demonstrated treatment persistence to be slightly higher in males compared to females in both PsA (65.4% vs 62.1%) and AS (69.4% vs 66.5%) groups. The reasons for treatment discontinuation, including those who were lost to follow up, through more than 3 years of follow-up, are presented in Table 1. Fifty-one % of female and 40% of male pts with PsA discontinued treatment due to lack of efficacy. In the AS cohort, treatment discontinuation due to lack of efficacy was comparable between female and male pts (37.1% vs 35.2%). Adverse events leading to treatment discontinuation were reported in a higher proportion of female pts in the AS cohort (25.8% vs 18.2%), while it was comparable in the PsA cohort (16.4% vs 19.8%). The reasons for treatment discontinuation with respect to body weight are outlined in Table 2. Based on body weight, 52.2% of pts weighing ≥90 kg and 41.0% of pts weighing < 90 kg discontinued SEC treatment due to lack of efficacy in the PsA cohort, while the proportion was comparable between the two groups in the AS cohort (≥90 kg=36.4%; < 90 kg=33.3%). SEC showed a favorable safety profile with no new or unexpected safety signals, consistent with previous reports.

Conclusion: In the current interim analysis after at least 3 years of follow-up, high persistence of secukinumab treatment with a favorable safety profile was observed in pts with PsA and AS. Furthermore, subgroup analysis revealed that higher proportions of female pts or pts with body weight ≥90 kg discontinued treatment due to lack of efficacy in the PsA cohort.

References:
1. Mease PJ, et al. RMD Open. 2021;7(2):e001600.
2. Marzo-Ortega H, et al. RMD Open. 2017;3(2):e000592.
3. McInnes IB, et al. Lancet. 2020;395(10235):1496–505.
Table 1. Persistence to secukinumab treatment and reasons for discontinuation by sex in patients with PsA and AS


Table 2. Persistence to secukinumab treatment and reasons for discontinuation by body weight in patients with PsA and AS

Disclosures: U. Kiltz, AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer, Biocad, Lilly, Grünenthal, Janssen, MSD, Roche, UCB; P. Sfikakis, Pfizer, AbbVie/Abbott, Novartis, Amgen, Janssen, Boehringer-Ingelheim, Celgene, Eli Lilly; N. Gullick, AbbVie/Abbott, Eli Lilly, Janssen, Novartis, UCB; A. THEODORIDOU, None; A. Kandyli, None; J. Brandt-Juergens, AbbVie/Abbott, Bristol-Myers Squibb(BMS), Janssen, Eli Lilly, Merck/MSD, Novartis, Pfizer, Roche, UCB, Sanofi-Aventis, Medac, Gilead, Gilead, Affibody; P. Goupille, AbbVie/Abbott, Amgen, Biogen, Bristol-Myers Squibb(BMS), Boehringer-Ingelheim, Chugai, Galapagos, Janssen, Eli Lilly, Merck/MSD, Novartis, Pfizer, Sanofi, UCB; N. Maiden, Eli Lilly, UCB; K. Gaffney, AbbVie, Eli Lilly, Novartis, UCB Pharma, Gilead; D. Peterlik, Novartis; B. Schulz, Novartis; E. Pournara, Novartis; P. Jagiello, Novartis.