Assessing research gaps and unmet needs in endometriosis

As‐Sanie, Sawsan; Black, Rebecca; Giudice, Linda C.; Valbrun, Tanika Gray; Gupta, Jhumka; Jones, Brittany; Laufer, Marc R.; Milspaw, Alexandra; Missmer, Stacey A.; Norman, Abby; Taylor, Robert N.; Wallace, Kedra; Williams, Zev; Yong, Paul J.; Nebel, Rebecca A.

doi:10.1016/j.ajog.2019.02.033

Cited by 200 publications

(220 citation statements)

References 89 publications

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“…This is consistent with previous studies indicating the lack of adequate response with current treatment regimens. 9,[14][15][16] In a systematic literature review of medical treatment responses for endometriosis-associated pain, 11-19% had no reduction in pain with treatment while 5-59% had remaining pain. 14 Additionally, discontinuation rates of 5-16% were noted due to lack of efficacy or adverse events.…”

Section: Discussionmentioning

confidence: 99%

“…[3][4][5][6] Both pharmacological and surgical treatments options are available for the treatment of endometriosis symptoms. 1,[7][8][9][10] Pharmacological treatment options include nonsteroidal antiinflammatory drugs, pain medications (including opioids), hormonally active contraceptives (oral, intrauterine and intramuscular), progestins, and gonadotropin-releasing hormone (GnRH) agonists (including goserelin, leuprolide, nafarelin, buserelin, and triptorelin) and antagonists (cetrorelix [subcutaneous injection] and elagolix [oral]). Surgical options include lesion ablation or excision potentially involving concomitant procedures such as hysterectomy with or without oophorectomy as well as pre-sacral neurectomy.…”

Section: Introductionmentioning

confidence: 99%

“…However, hysterectomies and presacral neurectomies are discouraged and should only be considered if all other treatment options have failed. 9 As most of these pharmacologic and surgical treatments, with the exception of complete lesion excision, are associated with high recurrence rates and for many women, initial treatments provide temporary or no symptom relief, a variety of different treatments are needed. 9 Elagolix is an oral, nonpeptide GnRH antagonist approved in the United States in 2018 for the management of moderate to severe pain associated with endometriosis.…”

Section: Introductionmentioning

confidence: 99%

“…9 As most of these pharmacologic and surgical treatments, with the exception of complete lesion excision, are associated with high recurrence rates and for many women, initial treatments provide temporary or no symptom relief, a variety of different treatments are needed. 9 Elagolix is an oral, nonpeptide GnRH antagonist approved in the United States in 2018 for the management of moderate to severe pain associated with endometriosis. 11 In the ELARIS Endometriosis I and II (NCT01620528 and NCT01931670) Phase III studies, elagolix, either at 200 mg twice daily or 150 mg once daily, significantly reduced dysmenorrhea (P<0.001) and nonmenstrual pelvic pain (P≤0.003) after 3 months of treatment compared with placebo for women with moderate or severe endometriosis.…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

<p>Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database</p>

Surrey¹,

Soliman²,

Johns³

et al. 2020

CEOR

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Purpose: Elagolix is an oral gonadotropin-releasing hormone antagonist approved in the United States for the management of moderate to severe pain associated with endometriosis. We performed a real-world evaluation of the demographic and clinical characteristics of women diagnosed with endometriosis who were initiating elagolix therapy in the United States. Patients and Methods: This retrospective cohort database analysis included women 18-49 years of age with ≥1 pharmacy claim for elagolix between August 2018 and December 2019 from the Copyright © 2020 Truven Health Analytics LLC. All Rights Reserved. Women had continuous medical and pharmacy health plan enrollment during the baseline period (year immediately preceding the index date [date of earliest elagolix claim]) and had ≥1 medical claim with endometriosis (International Classification of Diseases [ICD]-9/10 code [617.x and N80.x]) on or before the index date. Baseline demographics, comorbidities, ICD codebased endometriosis anatomic site, endometriosis-related treatments, and pain symptoms were summarized descriptively. Results: The study included 2083 patients with mean age at baseline of 33.2 ± 8.1 years. Comorbidities most commonly recorded were non-cancer, non-endometriosis pain (59.5%), including arthritis/joint pain (43.7%) and back/neck pain (31.7%), and mental disorder (40.7%), including anxiety (32.7%). The majority of endometriosis diagnosis codes recorded referred to unspecified location (52.3%) and pelvic peritoneum (23.0%); 61.0% of patients received a medical endometriosis-related treatment in the baseline period, with the most common treatments being contraceptives (various routes of administration, 40.2%) and progestins (31.7%). Additionally, 35.4% of the patients received an endometriosis-related surgery during baseline, with the most common being laparoscopy (33.2% of all patients). Opioids were used during the baseline period by 57.3% of the patients. For pain symptoms, 71.5%, 30.4%, and 19.3% of the patients had claims for pelvic pain, dysmenorrhea, and dyspareunia, respectively. Conclusion: Endometriosis therapies were used by a significant proportion of patients with endometriosis in the year immediately preceding elagolix initiation.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

<p>Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database</p>

Surrey¹,

Soliman²,

Johns³

et al. 2020

CEOR

View full text Add to dashboard Cite

show abstract

“…One common inflammatory disease that affects approximately 10% of reproductive aged women is endometriosis, which causes chronic pain and infertility, and is defined as the presence of endometrium-like tissue outside the uterus (As-Sanie et al, 2019). Epidemiological, biological, and molecular data all indirectly suggest links between the endometriosis and endometrial cancer (Painter et al, 2018;As-Sanie et al, 2019). In 1992, Koike et al (1992) identified increased production of 6-keto-PGF 1a , TXB 2 , and PGE 2 in endometrial cysts compared to non-endometrial cysts and normal ovaries.…”

Section: Cyclooxygenase In Uterine Cancermentioning

confidence: 99%

The Role of Eicosanoids in Gynecological Malignancies

et al. 2020

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Eicosanoids, bio-active lipid molecules, evoke a multitude of biological effects that directly affect cancer cells and indirectly affect tumor microenvironment. An emerging role has been shown for eicosanoids in the pathogenesis of gynecological malignancies which include cancers of the vulva, vagina, cervix, uterine, and ovary. Eicosanoid biosynthesis pathways start at the metabolism of phospholipids by phospholipase A2 then proceeding to one of three pathways: the cyclooxygenase (COX), lipoxygenase (LOX), or P450 epoxygenase pathways. The most studied eicosanoid pathways include COX and LOX; however, more evidence is appearing to support further study of the P450 epoxygenase pathway in gynecologic cancers. In this review, we present the current knowledge of the role of COX, LOX and P450 pathways in the pathogenesis of gynecologic malignancies. Vulvar and vaginal cancer, the rarest subtypes, there is association of COX-2 expression with poor disease specific survival in vulvar cancer and, in vaginal cancer, COX-2 expression has been found to play a role in mucosal inflammation leading to disease susceptibility and transmission. Cervical cancer is associated with COX-2 levels 7.4 times higher than in healthy tissues. Additionally, HPV elevates COX-2 levels through the EGFR pathway and HIV promotes elevated COX-2 levels in cervical tissue as well as increases PGE 2 levels eliciting inflammation and progression of cancer. Evidence supports significant roles for both the LOX and COX pathways in uterine cancer. In endometrial cancer, there is increased expression of 5-LOX which is associated with adverse outcomes. Prostanoids in the COX pathway PGE 2 and PGF 2α have been shown to play a significant role in uterine cancer including alteration of proliferation, adhesion, migration, invasion, angiogenesis, and the inflammatory microenvironment. The most studied gynecological malignancy in regard to the potential role of eicosanoids in tumorigenesis is ovarian cancer in which all three pathways have shown to be associated or play a role in ovarian tumorigenesis directly on the tumor cell or through modulation of the tumor microenvironment. By identifying the gaps in knowledge, additional pathways and targets could be identified in order to obtain a better understanding of eicosanoid signaling in gynecological malignancies and identify potential new therapeutic approaches.

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How long does a transvaginal ultrasound examination for endometriosis take in comparison to a routine transvaginal ultrasound examination?

Deslandes

Parange

Childs

et al. 2021

Australas J Ultrason Med

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Introduction: This study aimed to determine the additional time needed to perform an endometriosis transvaginal ultrasound (eTVUS) compared to routine transvaginal ultrasound (rTVUS). Methods: A retrospective case-control study was performed. The study group included 199 eTVUS performed between September 2019 and September 2020. The control group comprised 105 consecutive rTVUS studies performed in the same time period. The time stamps on the ultrasound images of all cases in both groups were reviewed to determine the time taken to perform each study. Mean, median, minimum and maximum scan times for both groups were calculated as was percentage difference between scan times. A two-tailed, unpaired t-test of the normalised data and a Mann-Whitney U test assessing time difference of scans between two groups were performed with P value <0.05 considered statistically significant. Results: Performing eTVUS took significantly longer than rTVUS with increases in the mean (8.4 vs 13.8 min, 64%), median (7 vs 12 min, 71%), minimum (4 vs 7 min, 75%) and maximum (19 vs 42 min, 121%) scan times. The Mann-Whitney U test indicated a statistically significant difference in the median scan times (5.0, CI 4.0-6.0), P < 0.001. An independent t-test of the normalised data revealed a significantly larger mean scan time for eTVUS than rTVUS, Mean = 9.05 95%CI [13.17-4.94], t(302) = 4.327, P < 0.001. R 2 = 0.583. Conclusion: Endometriosis transvaginal ultrasound added an average 5.4 min to rTVUS, which is statistically significant. For ultrasound departments wanting to offer this technique, doubling the scan time allocated to perform a transvaginal ultrasound (TVUS) is suggested.

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Assessing research gaps and unmet needs in endometriosis

Cited by 200 publications

References 89 publications

<p>Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database</p>

<p>Real-World Characterization of Women with Diagnosed Endometriosis Initiating Therapy with Elagolix Using a US Claims Database</p>

The Role of Eicosanoids in Gynecological Malignancies

How long does a transvaginal ultrasound examination for endometriosis take in comparison to a routine transvaginal ultrasound examination?

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