Background The European Union (EU) has introduced a new process to identify medicines that are being monitored particularly closely by regulatory authorities.

The black triangle will be used in all EU Member States to identify medicines subject to additional monitoring, such as belimumab.

Purpose To check the effectiveness and safety of belimumab.

Materials and methods A retrospective study from July 2012 to March 2013 of patients who were treated with belimumab.

To begin the treatment, the patients were required to meet the criteria set by the European Medicines Agency.

Their test results (immunoglobulins, antinuclear antibodies (ANA), anti-DNA, C3 and C4 levels) and medical records (subjective opinion of the patient, prednisone doses, adverse effects) were used to monitor the patients.

The results were collected at the beginning of the treatment, three and six months later and the subjective opinion of the patient at the end of the study.

Results Five women were treated (median age 36[25–50]), but only four were included because one abandoned the treatment due to thrombosis.

At the beginning of the treatment the patients had the following values: ANA+, anti-DNA+, low C3 and C4.

The treatment resulted in a reversal of the ANA and anti-DNA values, from positive to negative.

Regarding the C3 levels, a median of 90 mg/dl[71–103] was obtained in the first month. Within 3 months this value rose to 106 mg/dl[86–121], which meant an increase of 16 mg/dl. Another 3 months later, a median of 112 mg/dl[101–123] was achieved (increase of 6 mg/dl).

The prednisone dose was halved around week 36[32–40] of the treatment.

Most frequent adverse effects were: fatigue, nausea, diffuse aching, arthralgia.

Conclusions

1. Analytical parameters improved in every case.

2. Three patients referred subjectively to an improvement in symptoms.

3. One of the patients abandoned the treatment due to thrombosis, which cannot be related only to the treatment (until that point, the test values had been improving)

No conflict of interest.