Challenges and successes in the therapy of female patients

Lack of awareness of gender differences may lead to suboptimal treatment [1]. Prof. Andrea Rubbert-Roth, Dr. Diana Dan and PD Dr. Brigitte Uebelhart spoke at this year’s congress of the Swiss Society of Rheumatology (SGR) about the challenges in the therapy of axSpA and osteoporosis patients.

Compared to men, women receive a diagnosis for many diseases much later and respond differently to therapies [1]. Since timely diagnosis and adequate treatment significantly improve prognosis, research and consideration of gender-specific disease-related differences are essential for optimal care of all affected individuals [1].
The UCB Pharma AG symposium, moderated by Prof. Dr. Andrea Rubbert-Roth, was dedicated to the specifics of the diagnosis and treatment of women with axSpA and osteoporosis, as well as the role of certolizumab pegol (Cimzia®) and romosozumab (Evenity®).

Prof. Dr. med. Andrea Rubbert-Roth

Clinic for Rheumatology
Cantonal Hospital St. Gallen
St. Gallen

axSpA – “Adapting therapy for women”

With axSpA, rheumatologist Dr. Diana Dan presented a disease in which diagnosis is severely delayed, especially in women. Thus, according to an analysis of 1677 axSpA patients, the already very long diagnostic latency of an average of 5.7 years is even higher in young, HLA-B27-negative women [2]. One reason is that axSpA often manifests atypically in women and in the nonradiographic (nr-axSpA) form with decreased inflammation. For example, in one study, women were twice as likely to be affected by nr-axSpA as men, and in another study, women showed significantly reduced signs of inflammation [3, 4]. These findings also have implications for treatment, for example, nr-axSpA patients with higher inflammatory parameters may respond better to therapies with TNF blockers according to study results [5]. Dr. Dan also explained that many patients are of childbearing age and treatment should be compatible with a desire to have children. This should be seen in particular against the background that many pregnancies are unplanned. “According to the ACR guidelines, among TNF inhibitors, we can only use certolizumab pegol before and during pregnancy and lactation,” she emphasized(Table) [6].

Diana Dan, MD

Service de rhumatologie et Centre des maladies osseuses
Centre hospitalier universitaire vaudois (CHUV)
Lausanne

Table: ACR recommendations for medications before and during pregnancy and during lactation (adapted from [6]).

Severe osteoporosis – “Romosozumab is an effective and tolerable therapy”

Osteoporosis is a disease that particularly affects postmenopausal women [7]. Since July 2020, the sclerostin inhibitor romosozumab has been available to these women for the treatment of severe osteoporosis with high fracture risk [8]. Internist PD Dr. Brigitte Uebelhart summarized that the positive results of the three main studies ARCH, STRUCTURE and FRAME suggest the preferred use of romosozumab over alendronate and teriparatide. In direct comparison with the established antiresorptive drug alendronate or with placebo, romosozumab significantly reduced the recurrence of vertebral fractures within one year with comparable tolerability and, compared with alendronate, also significantly reduced the risk of clinical fractures [9, 10]. In addition, romosozumab was shown to be superior to both alendronate and teriparatide in improving bone mineral density [9, 11]. “The 15 patients currently being treated with romosozumab at our HUG in Geneva show very good efficacy with good tolerability and high adherence,” Dr. Uebelhart concluded.

PD Brigitte Uebelhart, M.D.

Service des maladies osseuses
Hôpitaux Universitaires Genève (HUG)
Geneva

Conclusion

axSpA and osteoporosis show large gender discrepancies [2, 7]. Thus, diagnosis is significantly delayed in female axSpA patients compared with male affected individuals, and clinical presentation and treatment response also differ [2-5]. In osteoporosis, the gender differences are most evident in prevalence, as this disease affects postmenopausal women with particular frequency [7]. In order to provide optimal care to all affected individuals, treating physicians should be aware of these differences [1]. Study data show that the TNF inhibitor certolizumab pegol (Cimzia®) and the sclerostin inhibitor romosozumab (Evenity®) can contribute to adequate care for both sexes [6, 9-11].

Source: Continuum of Care FOR HER: Focus on Axial Spondyloarthritis and Osteoporosis, Annual Congress of the Swiss Society of Rheumatology (SGR), Sept. 02, 2021.

Literature

1 Mauvais-Jarvis F et al. Sex and gender: modifiers of health, disease, and medicine. The Lancet, 2020. 396(10250): p. 565-582.

2 Redeker I et al. Determinants of diagnostic delay in axial spondyloarthritis: an analysis based on linked claims and patient-reported survey data. Rheumatology, 2019. 58(9): p. 1634-1638.

3 Kiltz U et al. Do patients with non-radiographic axial spondylarthritis differ from patients with ankylosing spondylitis? Arthritis care & research, 2012. 64(9): p. 1415-1422.

4 Tournadre A et al. Differences between women and men with recent-onset axial spondyloarthritis: results from a prospective multicenter French cohort. Arthritis care & research, 2013. 65(9): p. 1482-1489.

5 Sieper J et al. Early response to adalimumab predicts long-term remission through 5 years of treatment in patients with ankylosing spondylitis. Annals of the rheumatic diseases, 2012. 71(5): p. 700-706.

6 Sammaritano LR et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis care & research, 2020. 72(4): p. 461-488.

7. website of the Rheumaliga Schweiz. Osteoporosis. https://www.rheumaliga.ch/rheuma-von-a-z/osteoporose. Last accessed 04/01/2021.

8. Current professional information of Evenity® on https://www.swissmedicinfo.ch/.

9. Saag KG et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. New England Journal of Medicine, 2017. 377(15): p. 1417-1427.

10 Cosman F et al. Romosozumab treatment in postmenopausal women with osteoporosis. New England Journal of Medicine, 2016. 375(16): p. 1532-1543.

11. Langdahl BL et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. The Lancet, 2017. 390(10102): p. 1585-1594.

This article was created with the kind support of UCB Pharma AG.

CH-N-CZ-axSpA-2100026

Brief technical information Cimzia®

Brief technical information Evenity®

Article online since 20.12.2021