Vedolizumab treatment persistence and safety in a 2-year data analysis of an extended access programme.

BACKGROUND: Vedolizumab was shown to be effective and safe for patients with ulcerative colitis (UC) or Crohn's disease (CD) in the GEMINI phase 3 and long-term safety (LTS) studies. AIM: To report treatment persistence and safety results up to 2 years after enrolment in the vedolizumab extended access programme (XAP) METHODS: Vedolizumab XAP is a phase 3b/4, prospective, open-label, multinational, interventional study. At rollover from GEMINI LTS, patients who were experiencing continued clinical benefit with vedolizumab received reduced dosing frequency from every 4 weeks (Q4W) to every 8 weeks (Q8W). Patient persistence on Q8W dosing, incidence of relapse, and safety 2 years after enrolment were investigated. RESULTS: We enrolled 311 patients (142 UC and 169 CD). At baseline, 93.7% (UC) and 89.3% (CD) of patients were in clinical remission; 93.0% (UC) and 84.6% (CD) reduced dosing frequency to Q8W at enrolment. Of those who reduced dosing frequency to Q8W at enrolment, 93.9% (UC) and 91.6% (CD) remained on Q8W dosing; 6.1% (UC) and 8.4% (CD) re-escalated to Q4W dosing. Relapse was reported in 9.1% (UC) and 14.0% (CD) of patients who reduced dosing to Q8W. Adverse events related to vedolizumab were infrequent; no new events were reported. CONCLUSION: We observed high patient persistence on vedolizumab Q8W in the first 2 years after the reduction of dosing frequency in the XAP along with low rates of Q4W dose re-escalation and relapse. The safety profile was consistent with previous reports. ClinicalTrials.gov: NCT02743806.

Preliminary report on osteochondrosis in cattle in the north-western parts of South Africa.

The north-western part of South Africa, in particular, is well known for mineral imbalances. Aphosphorosis, resulting in rickets and osteomalacia, received a lot of attention at the turn of the nineteenth century (1882-1912). This was followed in 1997 by research on Vryburg hepatosis, another area-specific mineral imbalance-related disease in young calves reared on manganese-rich soil derived from the weathering of dolomitic (carbonate) rock formations. In 1982, a totally new syndrome (osteochondrosis) manifested in, amongst others, areas in South Africa where aphosphorosis was rife. Osteochondrosis was also identified in the south-western parts of Namibia as well as southern Botswana and other areas in South Africa. Osteochondrosis has a multifactorial aetiology and this study focused on the role of minerals, particularly phosphorus, in the development of the disease. A significant improvement in the clinical signs in experimental animals and a reduction of osteochondrosis occurred on farms where animals received bioavailable trace minerals and phosphorus as part of a balanced lick. An increase in the occurrence of the disease on farms during severe drought conditions in 2012-2013 prompted researchers to investigate the possible role of chronic metabolic acidosis in the pathogenesis of the disease.