Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Summary of the safety profile

Based on clinical trial and post-marketing data, the most commonly reported adverse drug reactions were anal abscess, proctalgia and anal fistula with the most commonly reported serious adverse drug reactions of anal abscess and anal fistula.

Tabulated list of adverse reactions

The following listing of adverse reactions is based on the clinical trial and post-marketing experience and is displayed by system organ class. The frequency of adverse reactions is defined from clinical trial experience using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).

Table 1. Adverse reactions
System Organ Class                               Frequency                            Adverse Reactions Infections and infestations                      Common                               Anal abscess* Gastrointestinal disorders                       Common                               Proctalgia*, † Common                               Anal fistula*
Injuring, poisoning and procedural               Common                               Procedural pain† complications
*Also seen in post-marketing experience
†Conditioning reactions occurring up to seven days after the fistula preparation for treatment administration.

Description of selected adverse reactions

The following adverse reactions were identified in the multicentre, pivotal clinical trial ADMIRE-CD.
Anal abscess
Up to week 52, 20 (19.4%) and 14 (13.7%) patients developed 21 and 19 anal abscesses in the Alofisel and control groups, respectively, of which 4 and 5 anal abscesses in respective groups (3.9% patients in both groups) were of severe intensity. Treatment-related anal abscess were reported in 8 (7.8%) and 9 (8.8%) patients in the Alofisel and control groups, respectively. Up to week 104, 15 (14.6%) and 8 (7.8%) patients developed 15 and 9 serious anal abscesses in the Alofisel and control groups, respectively.


Proctalgia
Up to week 52, 15 (14.6%) and 12 (11.8%) patients developed 20 and 17 proctalgia in the Alofisel and control groups, respectively, none of these proctalgia being serious in any group up to week104.
Treatment-related proctalgia were reported in 5 (4.9%) and 8 (7.8%) patients in the Alofisel and control groups, respectively. There were no patients in Alofisel group with proctalgia of severe intensity and 3.9% patients with 4 proctalgia in the control group.

Anal fistula
Up to week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistulas in the Alofisel and control groups, respectively, none of these being of severe intensity. Treatment-related anal fistula were reported in 3 (2.9%) and 3 (2.9%) patients in the Alofisel and control groups, respectively. Up to week 104, 5 (4.9%) and one (< 1.0%) patients developed 5 and 1 serious anal fistulas in the Alofisel and control groups, respectively.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il