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P466. Hypogonadal patients with Crohn's disease benefit from treatment with testosterone - data from an ongoing, long-term, observational registry study

F. Saad1, M. Nasser2, G. Doros3, W. Kurtz4, A. Haider5, L. Gooren6, 1Bayer Pharma, Global Medical Affairs Andrology, Berlin, Germany, 2University of Aleppo, Dpt. of Gastroenterology, Aleppo, Syrian Arab Republic, 3Boston University School of Public Health, Dpt. of Epidemiology and Statistics, Boston, United States, 4Klinikum Bremerhaven, Dpt. of Internal Medicine, Bremerhaven, Germany, 5Private Urology Practice, Urology, Bremerhaven, Germany, 6VU medical Center, Dpt. of Internal Medicine, Endocrine section, Amsterdam, Netherlands

Background

Anti-inflammatory effects of testosterone (T) have been demonstrated in numerous studies. T treatment has been found to be beneficial in rheumatoid arthritis and chronic obstructive pulmonary disease. Protective effects of T have been shown in experimental studies (e.g., Fijak M et al., J Immunol 2011, 186: 5162–5172). We previously reported effects of two years of T treatment in a small group of hypogonadal men with Crohn's disease (Haider A et al., Horm Mol Biol Clin Invest 2010; 2(3): 287–292).

Methods

In a prospective, cumulative, observational registry study, 73 hypogonadal men with Crohn's disease (n = 71) and Colitis ulcerosa (n = 2) with T ≤ 12 nmol/L from 2 centers in Bremerhaven, Germany and Aleppo, Syria received treatment with parenteral testosterone undecanoate on day 1, after 6 weeks and thereafter every 12 weeks for up to 75 months. 12 hypogonadal men of similar age with Crohn's disease who did not receive T served as an untreated control group. In total, 73 men received T and 12 hypogonadal men remained untreated. The Crohn's Disease Activity Index (CDAI) was assessed every 3 months. In addition, highly sensitive C-reactive protein (hsCRP) and leukocyte count were measured. The Aging Males' Symptoms Scale (AMS) was used as a self-administered quality of life (QoL) instrument.

Results

T levels at baseline were 9.37±1.08 nmol/l in the T group and 10.75±0.36 in the control group. During treatment, T increased to 15.72±0.53 and slightly declined in the control group. The CDAI decreased from 231.3±35.96 to 75.0 in the treated group and increased from 196.25±7.11 to 210.0 in the control group. hsCRP (mg/dl) levels at baseline were 14.01±9.18 in the T group vs 7.3±0.98 in the control group. They decreased to 2.63±1.91 after 72 months in the T group and increased to 13.7 in the control group. Leukocyte count decreased from 12.42±2. 46 to 5.97±0.51×103 cells/µl in the treated group and remained unchanged in the control group (from 11.38±1.29 to 12.7). AMS improved from 49.47±8.11 in the T group to 17.33±0.58. In the control group, AMS remained unchanged from 47.17±1.03 at baseline to 48 at the end of the observation period. 5 patients in the T group had osteoporosis. T-scores in these patients improved from approximately −2.9 to approximately −1.8.

Conclusion

Normalisation of T in hypogonadal men with Crohn's disease led to improvements of the CDAI, hsCRP, a reduction of leukocytes and an improvement of QoL. The mechanism of this improvement may be through anti-inflammatory and immunosuppressive effects of testosterone, reducing chronic inflammation of the intestinal wall in Crohn's disease.